Distal Tibial and Fibular Fractures: Clinical Guidelines

List of Abbreviations

EFA – external fixation apparatus

AO – Association for Osteosynthesis

Tibia – tibia

VTE – venous thromboembolism

AJ – ankle joint

DTFS – distal tibiofibular syndesmosis

DLLF – distal lower leg fractures

RTA – road traffic accident

Knee – knee joint

CT – computed tomography

HDL – high-density lipoproteins

LDL – low-density lipoproteins

PT – physical therapy

Ministry of Health of the Russian Federation – Ministry of Health of the Russian Federation

MRI – magnetic resonance imaging

LMWH – low-molecular-weight heparin from the B01AB Heparin group

NSAIDs – nonsteroidal anti-inflammatory drugs from the M01A Non-steroidal anti-inflammatory and antirheumatic products group

DLLF – distal lower leg fractures

TAT – tetanus antitoxin

HTIG – human tetanus immunoglobulin

SWD – surgical wound debridement

SCT – spiral computed tomography

TIA – transient ischemic attack

RF – risk factors

PRM – physical and rehabilitation medicine

FS – functional status

TENS – transcutaneous electrical nerve stimulation

SAB – surgical antibiotic prophylaxis

LCP – Locking Compression Plate

MIPO – Minimally Invasive Plate Osteosynthesis

ORIF – Open Reduction Internal Fixation

Terms and Definitions

Absolute stability – absence of micromotion at the fracture site, provided there is anatomical reduction and interfragmentary bone compression after fixation with hardware.

Allograft – a bone tissue fragment from another person (donor), typically cadaveric, that has undergone preservation processing.

External fixation device (EFD) – an orthopedic device containing an implant (a transosseous or extracorporeal element protruding through the skin, reaching the bone or inserted into it) and an external (non-implantable) support connecting bone fragments via transosseous elements in the treatment of fractures, pseudoarthrosis, or gradual lengthening (deformity correction) of a segment.

Autograft – a fragment of the patient's own bone harvested from a donor site for transplantation to fill a bone tissue deficit (bone defect).

Internal fixation device – an orthopedic implant implanted beneath the patient's skin that connects bone fragments in the treatment of fractures, deformities, or nonunions.

Impression – the process of articular surface fracture formation resulting from excessive pressure of the articulating bone exceeding the strength of spongy bone tissue, as well as the resulting impression fracture.

Fracture union – mutual connection of fragments by living bone tissue as a result of the successful completion of reparative regeneration.

Contracture – restriction of the range of motion in a joint.

Bone fragment – a portion of bone separated as a result of trauma, surgery, or a destructive process.

Migration of fixation elements – loss of the optimal position of fixation elements due to bone resorption around them, occurring when allowable cyclic loads or their number are exceeded, or due to errors in the surgical technique of implanting the element into the bone (within the context of this topic).

Load – mechanical force applied to a limb, bone, and fixation system during treatment, typically recurring with constant periodicity (cyclically).

Delayed union / Nonunion – changes in the reparative regeneration of bone tissue leading to a decrease in its rate, cessation, or formation of a callus insufficient to perform mechanical function.

Post-traumatic deformity – fracture consolidation with disruption of spatial relationships between fragments, including axial and rotational alignment.

Fixation stability – resistance of the system to external loads, allowing it to maintain the constancy of the mutual orientation of fragments and the optimal distance between them.

Fixation – a state in which relative or complete immobilization of fragments is achieved.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Distal lower leg fractures (DLLF) comprise extra-articular and intra-articular fractures of the distal tibial metaepiphysis, the localization of which is bounded by a square with sides equal to the widest part of the distal tibial metaphysis [12]. These fractures may be combined with fibular fractures at various levels, including the lateral malleolus [119, 120]. Frequently, these fractures are referred to by the term "pilon fracture." From the perspective of modern concepts of the anatomy of the distal tibial metaepiphysis, it is customary to distinguish three columns: the medial column, which includes the medial malleolus and the medial part of the articular surface of the pilon; the lateral column, consisting of the so-called Tillaux-Chaput fragment, the fibular notch, and the anterolateral part of the tibial articular surface; as well as the posterior column, including Volkmann's triangle (Volkmann’s fragment) or the posterior margin of the tibia, sometimes called the posterior malleolus [3].

Depending on the energy of the injury, the mechanism of trauma, and the position of the limb at the time of injury, various combinations of damage to one or more columns occur in each specific case. In addition, pilon fractures are often accompanied by injuries to the lateral malleolus and the distal tibiofibular syndesmosis. Unlike malleolar fractures, dislocations and subluxations in the ankle joint due to ligamentous stabilizer injuries are less common, and joint surface incongruency is usually caused by angular deformities (varus, valgus, ante- or retroversion) of the tibial metaepiphysis itself. Based on this, during surgical interventions and reconstruction of the injured segment, special attention must be paid not only to the anatomical reduction of the articular surface, but also to the restoration of all axial relationships of the lower leg and ankle joint [12, 15, 21, 119, 120].

Pediatric considerations: A subset of ankle fractures in children, known as transitional fractures, can occur within a 1.5–2-year age "window" (in girls aged 12–15 and boys aged 14–18), due to the progressive closure of the distal tibial physis, which begins centrally and ends laterally. Triplane fractures occur in the early stages of physeal closure, whereas juvenile Tillaux fractures occur when closure is nearly complete. Because most of the physis is already closed at this age, these fractures are not complicated by significant bone growth disturbances. Triplane fractures represent a complex, transitional, multiplanar variant of Salter-Harris type IV fractures occurring in adolescents at the stage of development when asymmetric partial closure of the distal tibial physis takes place. These fractures account for 5–10% of intra-articular ankle fractures in children. The triplane configuration consists of fracture lines running in the coronal plane through the posterior metaphysis, in the sagittal plane through the epiphysis, and in the horizontal plane through the physis.

1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)

Unlike malleolar fractures, which result from indirect low-energy trauma with a rotational component, fractures of the distal tibial metaepiphysis are in most cases high-energy injuries resulting from the talus impacting the articular surface of the tibia.

According to the mechanism, two main groups of distal leg fractures are distinguished. The first and prevailing group consists of high-energy fractures resulting from falls from a height (catastrophic trauma) or motor vehicle accidents. They are often accompanied by extensive soft tissue damage, can be open, and are characterized by significant destruction of the articular surface and the metaepiphysial zone of the tibia [30, 48, 68].

The second group comprises low-energy rotational fractures, which may result from sports injuries (e.g., skiing or falls from standing height). Low-energy pilon fractures often occur in the setting of osteoporosis. Evaluation of the injury mechanism, soft tissue status, and bone quality is of great importance in choosing treatment tactics and determines its outcomes [30, 48, 68]. It should be noted that different injury mechanisms lead to predominant damage to one or more columns of the tibia, causing typical axial fragment displacements as well as the formation of varus or valgus deformity. Three main variants of pilon fractures are distinguished: axial compression of the tibia; its varus deformity with compression of the medial column and "tensioning" of the lateral column; and valgus deformity with compression of the lateral column. Surgical approaches are planned depending on the predominant damage to one of the three columns. In this case, the compressed column requires the application of a buttress plate on the corresponding side to restore the anatomy of the distal tibia [13, 14, 99].

In addition, the specific architectonics of the fracture are also influenced by the position of the foot at the time of injury. Under the action of the traumatic energy propagating along the axis of the leg, the talus, striking the articular surface of the tibia, predominantly destroys the anterior parts of the latter if the foot was in dorsiflexion at the time of injury. If the foot was in plantarflexion, the posterior parts of the tibia suffer to a greater extent [21]. In a neutral foot position, for example when a patient falls from a significant height onto a straight leg, substantial central depression occurs with impaction of the articular surface and cancellous bone in the metaphyseal region. The latter injuries are among the most complex in surgical reconstruction, requiring re-impaction of the articular surface and bone defect grafting in the metaepiphysial zone [12, 21].

1.3 Epidemiology of the Disease or Condition

Fractures of the distal tibia account for 7% to 10% of all tibial fractures [68] and about 1% of all lower extremity fractures [87]. In the group of patients with high-energy pilon fractures resulting from motor vehicle accidents and falls from a height, 27% to 51% of victims have polytrauma [21], in 0–5% of cases these fractures are complicated by vascular injuries and compartment syndrome, and in 12–56% of cases they are open [21]. However, according to T.P. Rüedi, who studied pilon fractures in victims of skiing accidents, the proportion of open injuries does not exceed 3–6% [78]. According to modern literature, both high-energy and low-energy injuries are combined with fibular fractures in 70–80% of cases [21].

Pediatric considerations: The proportion of children with leg bone fractures in the general fracture structure ranges from 21.3% to 37.0% and accounts for 43.8% of long bone fractures of the lower extremities. Moreover, among all leg fractures in children, distal injuries occur in 54% of cases. An increase in the proportion of leg fractures in children with age is also noted, from 1.8% in children aged 2–5 years to 28.8% in those aged 12–15 years. [106, 118]

1.4 Features of Coding the Disease or Condition

S82.3 – Fracture of lower leg, part unspecified

S82.30 – Fracture of lower end of tibia, closed

S82.31 – Fracture of lower end of tibia, open

S82.7 – Multiple fractures of lower leg

S82.70 – Closed multiple fractures of lower leg

S82.71 – Open multiple fractures of lower leg

S82.8 – Fractures of other parts of lower leg

S82.80 – Fractures of other parts of lower leg, closed

S82.81 – Fractures of other parts of lower leg, open

S82.9 – Fracture of unspecified part of lower leg

S82.90 – Fracture of unspecified part of lower leg, closed

S82.91 – Fracture of unspecified part of lower leg, open

S89.7 – Multiple injuries of lower leg

S89.8 – Other specified injuries of lower leg

1.5 Classification of the disease or condition

Fractures of the distal leg bones belong to the group of peri-articular and intra-articular fractures of the ankle joint.

From the standpoint of choosing operative treatment tactics, the AO/ASIF (Association for Osteosynthesis) classification is currently the most widely used. According to the universal AO fracture classification, fractures of the distal leg bones correspond to code 43 [69]. Fractures are subdivided into three types based on the degree of involvement of the articular surface of the tibia:

• 43-A - Extra-articular fracture:

• 43-A1 - Extra-articular fracture, metaphyseal simple;

• 43-A2 - Extra-articular fracture, metaphyseal wedge;

• 43-A3 - Extra-articular fracture, metaphyseal multifocal/complex (Fig. 29, a).

• 43-B - Partial articular fracture:

• 43-B1 - Partial articular fracture, pure split (Fig. 29, b);

• 43-B2 - Partial articular fracture, split-depression;

• 43-B3 - Partial articular fracture, multifocal with depression;

• 43-C - Complete articular fracture:

• 43-C1 - Complete articular fracture, articular simple, metaphyseal simple;

• 43-C2 - Complete articular fracture, articular simple, metaphyseal multifocal;

• 43-C3 - Complete articular fracture, multifocal articular, simple, wedge, or multifocal metaphyseal;

According to the recommendation of the latest 2018 revision of the AO classification, associated fibular fractures are considered separately in segment 43 [69]. If present, they are classified as:

• 4F – Fibula:

• 4F-1 – Proximal segment:

• 4F-1A – Simple fracture;

• 4F-1B – Multifocal fracture;

• 4F-2 – Diaphysis:

• 4F-2A – Simple fracture;

• 4F-2B – Wedge or multifocal fracture;

• 4F-3 – Distal segment:

• 4F-3A – Simple fracture;

• 4F-3B – Wedge or multifocal fracture.

Comments.

The 1969 Rüedi–Allgower classification of intra-articular pilon fractures remains highly relevant, categorizing these injuries into three types: Type I — intra-articular fracture of the distal metatibial epiphysis without fragment displacement; Type II — intra-articular fracture of the distal metatibial epiphysis with fragment displacement; Type III — intra-articular fracture of the distal metatibial epiphysis with fragment displacement and articular surface impression [78].

Modern views on the surgical management of pilon fractures mandate CT scanning to delineate fracture architectonics and guide surgical strategy [89]. Preoperative planning should utilize pilon fracture classifications based on CT scan data. For instance, the classification by D. Leonetti and D. Tigani (2017) accounts for the extent of articular surface involvement, magnitude of displacement, number of tibial joint fragments, predominant orientation of the fracture plane at the joint level, and comminution degree [61]. According to this classification, four fracture types are distinguished. Type I includes non-displaced intra-articular fractures (Type Ia) and extra-articular fractures (Type Ib). Type II comprises displaced intra-articular fractures with two main fragments: subtype IIS with a sagittal fracture plane dividing the pilon into medial and lateral fragments; subtype IIF with a frontal fracture plane dividing the pilon into anterior and posterior fragments. Type III involves three main fragments and is similarly subdivided into subtypes IIIS and IIIF. Type IV includes four-fragment and comminuted fractures, including impaction of the central fragment of the distal tibial articular surface into the metadiaphyseal zone. Determining the pilon fracture type according to this proposed classification allows for more accurate surgical planning, selection of the optimal surgical approach or combination of approaches, and application of a suitable implant for stable fixation. Thus, if the primary fracture plane is sagittal (types IIS and IIIS), a medial fixator placement with screws inserted perpendicularly to the fracture plane is preferred. If the fracture plane is frontal (IIF and IIIF), the implant should be placed on the anterior or posterior surface of the pilon. For Type IV fracture fixation, multiple implants may be used [61].

For open fractures of the distal leg bones, the classification by R.B. Gustilo and J.T. Anderson (1976) [39], as modified by R.B. Gustilo, R.M. Mendoza, and D.N. Williams (1984) [40], is used:

Type I – open fracture, the wound is minimally contaminated, wound size is less than 1 cm;

Type II – open fracture, the wound is greater than 1 cm and less than 10 cm in length without significant soft tissue damage, flaps, or skin detachment;

Type IIIA – open fracture, soft tissues cover the fragments, no periosteal stripping in the presence of extensive soft tissue damage or flaps, or in high-energy trauma regardless of wound size;

Type IIIB – open fracture with an extensive soft tissue defect, periosteal stripping, and a comminuted fracture pattern, often with significant microbial contamination of the wound;

Type IIIC: open fracture complicated by major vascular injury requiring surgical reconstruction, regardless of the extent of soft tissue damage.

Pediatric considerations: in children, the Salter-Harris classification is the most widely used system for fractures involving the growth plate. Each type of injury in this classification carries prognostic significance.

Type I — Epiphyseolysis: the fracture runs exclusively through the growth plate.

Type II — Metaphyseolysis: the fracture runs through the growth plate and then extends into the metaphysis.

Type III — Epiphyseal fracture: the fracture runs through the growth plate and then extends into the epiphysis.

Type IV — Metatepiphyseal fracture: the fracture line crosses the metaphysis, growth plate, and epiphysis.

Type V — Impacted fracture with growth plate injury: a fracture characterized by "destruction and impaction" of the growth plate resulting from an axial loading force. This fracture type is extremely rare (about 1%), and premature closure of the growth plate frequently occurs. In pediatric practice, the Dias-Tachdjian classification of distal leg injuries is also used, which accounts for the presence of growth plates. Ankle injuries are categorized based on foot position at the time of injury and the direction of the traumatic force [26]. Additionally, there are two specific pediatric fractures that are exceptions to this classification: the Tillaux fracture (Salter-Harris III) and the triplanar fracture. Specific fractures also occur in children, including those involving the distal bones of the leg—namely, subperiosteal fractures and greenstick fractures.

1.6 Clinical presentation of the disease or condition

The clinical presentation of a distal leg bone fracture is characterized by severe pain in the distal leg and ankle joint, functional impairment, smoothing of contours and edema in the lower third of the leg and ankle, tenderness on palpation and axial loading. In the presence of displacement, shortening of the leg segment is observed, along with deformity at the level of the distal leg and ankle joint, the type of which (valgus, varus deformity, ante- or retrocurvation) depends on the direction of traumatic energy and foot position at the moment of injury. Pathological mobility in the distal leg and ankle region is detected [21, 119].

Complaints: pain in the distal leg and ankle joint, impaired and sharply painful flexion and extension of the foot, pathological mobility, deformity of the leg and ankle joint, swelling and edema of the leg, ankle joint, and foot, wound pain (in open fractures), possible protrusion of bone fragments through the wound, presence of subepidermal fllyctenulae with exudate and areas of skin de-epithelialization upon rapid progression of soft tissue swelling. In unreduced fractures with significant fragment displacement, skin necrosis may develop over prominent bone fragments. When compartment syndrome develops, the patient reports severe pain that sharply increases with passive dorsiflexion of the hallux, along with impaired foot and toe mobility. As compartment syndrome progresses, cutaneous sensation in the foot becomes impaired [15, 21, 120].

History: a history of trauma, with the patient describing a characteristic mechanism of injury.

The classic mechanism of injury is axial loading, where the talus strikes the articular surface of the tibia, resulting in a comminuted fracture and impression of the central portion of the articular surface. This mechanism occurs during falls from a height, whether low (2-3 m) or significant (several stories of an apartment building), with the severity of articular surface destruction largely depending on bone quality and the patient's age. This same mechanism of pilon injury can occur in motor vehicle accidents when car engine components shift into the pedal area where the driver's feet were positioned at the moment of impact [12, 15, 21, 87].

In some cases, a pilon fracture may result from a direct blow to the distal leg and ankle joint.

Low-energy extra-articular and simple intra-articular fractures resulting from rotation with a fixed foot can be sports-related injuries, such as from ice skating or rollerblading, or occur—similar to malleolar fractures—from twisting the ankle and falling from a standing height [12, 15, 21].

Objective examination: edema of the leg and ankle joint, limitation of active and passive range of motion due to severe pain, visually apparent deformity of the leg and ankle joint, tenderness upon palpation of the distal leg and ankle, bone fragment crepitus, and pathological mobility in the distal leg and ankle region [15, 21, 119, 120]. With pronounced leg deformity, excessive skin tension may occur due to protruding bone fragments, most frequently localized on the medial surface of the leg and ankle joint [21, 87].

In cases of severe edema, serous or hemorrhagic subepidermal blisters—"fllyctenulae"—frequently form, which subsequently progress to areas of skin de-epithelialization, dry scab formation, and skin necrosis. Open fractures present with wounds, most commonly located on the medial surface of the distal leg [21, 87].

In high-energy fractures accompanied by marked edema, peripheral circulation and innervation of the foot may be compromised, alongside the development of compartment syndrome characterized by severe pain, tense edema, pallor of the skin, exquisite tenderness upon passive toe movement, impaired skin sensation of the leg and foot, and absent peripheral arterial pulses [12, 15, 21, 87].

When a distal leg bone fracture is suspected, all patients must be evacuated to a medical facility for diagnosis verification.

Pediatric age characteristics: in certain fractures in children, the clinical presentation may be less pronounced than in adults. With subperiosteal fractures, limb weight-bearing capacity may not be significantly impaired, and marked edema may be absent, which complicates differential diagnosis between a fracture, contusion, and ligament sprain. To determine the appropriateness of radiography in traumatic injuries of the lower third of the leg bones, the Ottawa ankle rules (University of Ottawa, Ottawa, Canada) can be used. Originally developed for adult patients, their accuracy has subsequently been demonstrated in children over 5 years of age. Based on these criteria, performing radiographs is justified if the patient is unable to take more than four steps with full weight-bearing on the injured limb, or if there is pain or tenderness on palpation in the area of the apex or the posterior surfaces of the medial and lateral malleolus over the proximal 6 cm.

2. Diagnostics, medical indications and contraindications for diagnostic methods

Criteria for establishing the diagnosis/condition:

• anamnestic data: indication of a characteristic mechanism of lower limb injury (turning of the foot and lower leg, fall, blow to the distal lower leg and ankle joint, road traffic accident, high-energy trauma, etc.)

• physical examination data: impaired function of the injured segment, deformity, local edema, and tenderness of the injury area (tenderness increases with axial load), presence of pathological mobility and/or bone fragment crepitus

• instrumental examination data: radiographic signs of a fracture based on lower extremity radiography in 2 projections. In fractures of the distal leg bones with suspected intra-articular injury, an additional lower extremity CT scan is recommended as prescribed by the on-duty or attending trauma surgeon to clarify the fracture pattern and determine the degree of fragment displacement.

2.1 Complaints and Anamnesis

In most cases, patients present with complaints described in Section 1.6 "Clinical Presentation"

• All patients with suspected distal lower leg fracture are recommended a thorough collection of complaints and anamnesis for diagnostic purposes [12, 15, 21, 119, 120, 121].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

2.2 Physical Examination

Physical examination findings are described in Section 1.6 "Clinical Presentation"

• All patients with suspected distal lower leg fracture evaluation of the following parameters (initial appointment (examination, consultation) by an orthopedic trauma surgeon) is recommended to be performed no later than 1 hour after admission to the hospital, with mandatory indication of the results in the medical record for diagnostic purposes:

• assessment of somatic status;

• visual and palpation assessment of local status [12, 21, 119, 120, 121];

• measurement of blood pressure on peripheral arteries;

• measurement of body temperature (general thermometry) [107, 120];

• assessment of the risk of venous thromboembolic events (Appendix G1) [103].

Level of Evidence 5Grade of Recommendation C (Level of Evidence – 5).

Comment: Pediatric age characteristics: there are no specific criteria for assessing the risks of thromboembolic events in children with traumatic injuries. Important criteria include a history of thrombosis and thromboembolism, blood coagulation disorders, and placement of a central venous catheter [109].

• All patients with suspected distal lower leg fracture are recommended an assessment of the state of innervation and blood circulation in the peripheral parts of the lower limb in order to rule out neurovascular bundle injury at the fracture level or compartment syndrome [12, 21, 119, 120, 121].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

Comment: Pediatric age characteristics: taking into account the characteristics of the pediatric body, which in some cases leads to a discrepancy between the clinical presentation and the severity of injuries, a detailed clinical assessment is necessary for the timely detection of secondary complications (vascular and nerve injuries, compartment syndrome, etc.) [121].

• All patients with suspected distal lower leg fracture are recommended an assessment of the soft tissues and the severity of edema in order to rule out hematomas and open fractures [3, 12, 15, 21, 87, 119, 120].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

• When deciding on surgical treatment for a distal lower leg fracture in adult patients, it is recommended to collect an anamnesis and perform a physical examination to identify risk factors and cardiovascular diseases [9, 43].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

Comment: Risk factors for the development of cardiovascular diseases include: arterial hypertension, smoking, dyslipidemia (elevated total cholesterol >4.9 mmol/L and/or LDL cholesterol >3 mmol/L, and/or HDL cholesterol <1.0 mmol/L in men, <1.2 mmol/L in women, and/or triglycerides >1.7 mmol/L), diabetes mellitus, and a family history of premature cardiovascular disease (<55 years for men and <65 years for women) [102]. Established cardiovascular disease is defined as: coronary artery disease, cerebrovascular disease, peripheral atherosclerosis, chronic heart failure, pulmonary hypertension, valvular heart disease, or cardiomyopathies [9, 29].

• All adult patients scheduled for elective surgical treatment of a lower leg fracture are recommended to undergo risk assessment for perioperative cardiovascular complications, taking into account the type of planned surgical intervention regardless of the presence of comorbidities [36, 43].

GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5).

Comments: Perioperative risk assessment is not performed when surgical treatment is indicated on an emergency (<6 hours) or urgent (6–24 hours) basis. Minor orthopedic procedures are associated with a low risk of cardiovascular complications (30-day postoperative risk of myocardial infarction or cardiovascular death <1%). Major orthopedic procedures are associated with an intermediate (moderate) risk of cardiovascular complications (30-day postoperative risk of myocardial infarction or cardiovascular death of 1–5%) [114].

• To assess the risk of perioperative cardiovascular complications in adult patients, it is recommended to use a special algorithm [Appendix B2] [33, 36].

GPR CLOC 3Grade of Recommendation C (Level of Evidence – 3).

• Elective surgical treatment of a lower leg fracture in adult patients is recommended without additional testing if their cardiovascular risk is determined to be low. In patients with intermediate or high perioperative risk of cardiovascular complications, assessment of the patient's functional status is recommended [81, 114].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

2.3 Laboratory Diagnostics

• All patients diagnosed with a lower leg fracture who are scheduled for surgical treatment are recommended to undergo the following laboratory tests for diagnostic purposes:

• complete blood count;

• urinalysis;

• general clinical biochemical blood test [120];

• determination of ABO blood groups and Rh factor (D antigen) [107];

• determination of hepatitis B virus surface antigen (HBsAg) in the blood;

• determination of class G antibodies (anti-HCV IgG) to Hepatitis C virus in the blood;

• determination of antibodies to Treponema pallidum in the blood,

• determination of class M and G antibodies (IgM, IgG) to human immunodeficiency virus HIV-1/2 and p24 antigen (Human immunodeficiency virus HIV 1/2 + Agp24) in the blood;

• coagulation screening (basic hemostasis assay);

• determination of the international normalized ratio (INR) [107, 120].

LEL 5Grade of Recommendation C (Level of Evidence – 5).

• When making decisions regarding the surgical treatment of a lower leg fracture in adult patients, it is recommended to measure blood levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in cases of intermediate or high risk of cardiovascular complications and low functional status (see Appendix B2) [43, 114, 122, 123].

LeE 2Grade of Recommendations B (Level of Evidence – 2).

2.4 Instrumental Diagnostics

• All patients with suspected lower leg fracture are recommended to undergo radiography of the lower leg (radiography of the lower extremity, knee joint, ankle joint) including both the ankle and knee joints in two projections for diagnostic purposes [3, 12, 15, 21, 82, 87, 119, 120].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

Comments: Radiographs make it possible to assess limb axis deviation and draw preliminary conclusions regarding the direction of the traumatic forces and primary traumatic deformation. For a correct evaluation of initial radiographs, it is recommended to determine the deviations of standard reference lines (the anatomical and mechanical axis of the tibia) and angles [113]. Normally, in the frontal plane, the articular surface of the tibia is inclined at an angle of 89 (86–92) degrees to the tibial axis, forming a minor physiological valgus in some cases, and a minor varus in others. In the sagittal plane, the inclination angle of the tibial articular surface is 80 (78–82) degrees [113]. To identify primary traumatic deformation (valgus, varus, neutral position, ante- or retrocurvation of the tibia), radiographs of the contralateral limb are required in some cases. Based on initial radiographs, it is necessary to assess the nature and type of the fracture, the degree of involvement of the lateral, medial, and posterior columns (compression or distraction of the respective columns), as well as the presence, type, and localization of the fibular fracture.

Pediatric considerations: if fracture diagnostics is difficult (transphyseal injuries, subperiosteal fractures), comparative radiography of the contralateral limb segment is recommended. Furthermore, when assessing the lower limb axis and radiomorphometric parameters, one should take into account age-related features and, whenever possible, perform a comparative evaluation with the contralateral limb. In subperiosteal fractures, the fracture line is usually not visible on radiographs, and the radiological diagnosis of such a fracture consists in identifying an angular disruption of the metaphyseal contour ("step-off") on standard radiographs.

• All patients with distal lower leg fractures are recommended to undergo spiral computed tomography (SCT) of the distal lower leg (lower extremity computed tomography) and the ankle joint (joint computed tomography) when an intra-articular fracture is suspected, in order to clarify the diagnosis [3, 12, 15, 21, 61, 89].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

Comments: SCT provides additional information on the nature of the fracture, the degree of fragment displacement, and the presence and localization of articular surface depression of the tibia. [3, 12, 15, 21, 61, 89] A thorough evaluation of 3D reconstructions, coronal, sagittal, and axial CT slices is recommended. To assess distal tibiofibular syndesmosis (DTFS) congruence on axial slices, it is recommended to use the contralateral limb as a reference.

In two-stage surgical treatment of pilon fractures, it is advisable to perform SCT after applying a primary external fixation device (EFD) under moderate distraction, since distraction provides primary reduction of major fracture fragments through ligamentotaxis, which significantly facilitates preoperative planning [6, 48].

• All adult patients with distal lower leg fractures are recommended to undergo Doppler ultrasound of the lower limb vessels (arteries and veins) when impaired blood supply to the distal parts of the injured limb is suspected, in order to rule out major vessel injury [21].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

• Echocardiography may be considered prior to planned surgical treatment of a distal lower leg fracture in patients with low functional status, elevated NT-proBNP levels, left ventricular systolic dysfunction, cardiomyopathies, valvular heart disease, newly detected heart murmurs, and suspected cardiovascular disease [18, 84, 114].

LEL 5Grade of Recommendation C (Level of Evidence – 5).

• If acute or unstable clinical conditions are detected, it is recommended to postpone elective surgical treatment of the distal lower leg fracture until the cardiac status improves and the patient's condition stabilizes; transfer of the patient to a regional vascular center or a specialized cardiology department is indicated [114].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

Comments.After confirming the diagnosis of a distal lower leg fracture using imaging methods, the issue of hospital admission is addressed. The patient should be hospitalized if surgical treatment is planned. If conservative treatment is chosen, lower limb immobilization may be performed. The method of primary immobilization will be described below in the section dedicated to conservative treatment.

2.5 Other Procedures

• When treating patients with distal lower leg fractures, the attending physician is recommended to take into account the following indications for consultations with allied specialists in clinical practice in order to rule out conditions threatening the patient's life and health:

• neurosurgeon consultation: in case of nerve injury or suspected nerve injury and concomitant traumatic brain injury;

• surgeon consultation: in case of suspected or objectively diagnosed concomitant abdominal and/or thoracic trauma;

• neurologist consultation: in case of nerve injury or suspected nerve injury and concomitant traumatic brain injury;

• cardiovascular surgeon consultation: in case of concomitant vascular injury or suspected vascular injury;

• physician (general practitioner/internist) consultation: in the presence of comorbid medical conditions (according to medical history) [115, 120, 121].

RG CLE 5Recommendation Grade C (Level of Evidence 5).

Comments: Pediatric considerations: consultations with pediatric specialists are also prescribed to children with distal lower leg injuries in the presence of appropriate indications.

3. Treatment, including drug and non-drug therapies, diet therapy, and pain management

3.1 Conservative Treatment

• Patients with distal lower leg fractures upon admission to the hospital are recommended the following minimum scope of care in the emergency department:

• ensuring thermal comfort for the patient;

• adequate pain management;

• immobilization of the injured lower limb;

• correction of fluid and electrolyte imbalances [107, 120, 121].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

• Patients with distal lower leg fractures are recommended to undergo conservative treatment to achieve bone union in the following cases:

• isolated distal tibial fracture without fragment displacement;

• distal lower leg fracture in elderly patients with severe comorbidities and low quality-of-life expectations;

• in the presence of comorbid conditions that are a contraindication to surgical treatment;

• in case of the patient's voluntary refusal of surgery [12, 15, 21, 119, 120, 121].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

Comments. Conservative treatment consists of closed reduction of fragments under adequate anesthesia and immobilization. During reduction, it is necessary to take into account the existing primary traumatic deformation and perform manipulations to restore the lower leg axis. [12, 15, 21, 119, 120]. The quality of the performed reduction must be checked using anteroposterior and lateral radiographs. The criteria for an adequate closed reduction are the elimination of gross fragment displacement and the restoration of ankle joint congruence. In case of unsuccessful closed reduction of fragments, as well as significant soft tissue swelling and contraindications to surgery, temporary skeletal traction through the calcaneus or a fixing bandage that prevents soft tissue compression as edema increases is recommended.

Immobilization of the injured lower limb (application of an immobilization bandage for bone fractures) is performed using various types of fixing bandages. In cases where closed manual reduction is used, it is recommended to use a U-shaped plaster slab, supplemented with a posterior plaster slab or a primarily incised circular plaster cast, extending above the level of the knee joint (up to the lower third of the thigh). An important condition for conservative treatment with prolonged plaster immobilization (application of a plaster cast for bone fractures) is monitoring the state of soft tissue edema and maintaining blood supply to the distal parts of the limb. A patient undergoing conservative treatment needs constant contact with the attending orthopedic trauma surgeon in the outpatient department to monitor the condition of the bandage and perform staged radiographs. Repeated follow-up radiographs must be taken on day 7 (5–10) after the injury to rule out secondary fragment displacement and every 4–6 weeks until signs of radiologic fracture healing appear on radiographs in two standard projections. The duration of immobilization and axial load restrictions are determined by the dynamics of fracture consolidation and average 3–4 months. [21, 119, 120].

Pediatric features:conservative treatment in the form of plaster immobilization is the primary method of treatment. The remodeling capacity of children's bones makes it possible to correct residual deformities as they grow; however, during closed reduction, one should strive for the anatomical restoration of the damaged segment. The remodeling potential depends on the patient's age, fracture location, and the magnitude of the residual deformity. In the 3–10 age group with conservative treatment, it has been noted that shortening of up to 10 mm can be fully or partially compensated by accelerated growth. Varus deformity <15° may correct spontaneously, whereas valgus deformity and posterior angular deformity persist to a certain degree, and rotational deformities do not correct[79]. In children under 12 years of age, anterior angular deformity shows maximum correction (52.7%), to a lesser extent varus (40.9%), then valgus (23.9%), and to the least extent posterior angular deformity (18.5%). Complete correction is possible for anterior angular deformity – 12°, posterior – 6°, varus – 10°, and valgus – 8°[31]. In stable fractures (subperiosteal fractures, transverse tibial fractures without fibular fracture), plaster immobilization is performed with the foot in a neutral position up to the upper third of the lower leg (depending on the fracture type, severity of edema, and skin changes, this may be a plaster slab, a circular plaster cast, or a primarily incised circular plaster cast). In fractures of both bones of the lower leg, and comminuted extra-articular fractures, plaster immobilization is carried out up to the upper third of the thigh with the knee joint flexed at an angle of 45–60^° to eliminate rotational movements of the lower leg and prevent secondary displacement. In displaced fractures, closed reduction is performed using traction and angular deformation followed by plaster immobilization up to the upper third of the thigh. Closed reduction can be performed under either general or regional anesthesia (depending on the fracture type and the child's age). In unstable injuries, the position of the foot in the plaster cast is dictated by the fracture type and the method of closed reduction, which is required to maintain the fragments in the specified position. Following plaster immobilization, careful clinical monitoring is required for the timely detection of potential complications (tissue compression by the cast, trophic disorders, phlyctenae, etc.). After 5–7 days, radiographic follow-up is indicated to rule out secondary fragment displacement. The duration of plaster immobilization depends on the fracture type and the rate of consolidation, and typically ranges from 3–6 weeks.

3.2 Surgical Treatment

The choice of surgical tactics for a pilon fracture is determined by the fracture type, soft tissue condition, presence of associated injuries, and individual patient characteristics. When performing osteosynthesis, the priorities are restoring the axis, length, and rotation of the lower leg, anatomical reconstruction of the articular surface of the tibia, and restoring ankle joint stability.

• Patients with a combination of a distal tibial fracture and soft tissue injuries are recommended to undergo a soft tissue assessment in order to determine further treatment tactics [12, 16, 119, 120, 121].

GCR CLOE 5Grade of Recommendation C (Level of Evidence – 5).

Comments: In the presence of open fractures, the choice of further tactics is determined in accordance with the recommendations for treating patients with open distal tibial fractures.

In the presence of closed soft tissue injuries (contusions, abrasions, subcutaneous hemorrhages, hematomas, skin detachment, etc.), the choice of further treatment tactics, timing, and method of tibial osteosynthesis are determined by the severity of soft tissue damage and the patient's general condition [12, 16, 119, 120].

• presence of a displaced distal tibial fracture;

• presence of an intra-articular fracture of the distal tibia accompanied by disruption of the congruity of the articular surfaces forming the ankle joint;

• open fractures of the distal lower leg bones;

• fracture of the distal lower leg bones as part of polytrauma;

• unsatisfactory results of conservative treatment [3, 12, 15, 48, 119, 120, 121].

Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).

Comment: Pediatric considerations: Stabilization of extra-articular fractures in the absence of stable retention of bone fragments is most often performed using Kirschner wires (orthopedic bone wire***). The presence of functioning growth plates imposes certain limitations on the choice of stabilization method – fracture fixation with transphyseal placement of screws, positioning of plates (non-absorbable sterile bone fracture fixation plate with screws***, non-absorbable non-sterile bone fracture fixation plate with screws***, non-absorbable sterile orthopedic bone screw***, non-absorbable non-sterile orthopedic bone screw***) bridging the growth plates with screws can lead to secondary deformities as the child grows and is not recommended. If transphyseal compression is required, the Weber technique may be the method of choice. It should be noted that transphyseal fixation elements must be removed in a timely manner to prevent secondary deformities. In intra-articular fractures, fixation can be performed using compression screws (non-absorbable sterile orthopedic bone screw***, non-absorbable non-sterile orthopedic bone screw***), but it is recommended to place them parallel to the physis (without crossing) – from epiphysis to epiphysis, from metaphysis to metaphysis [93]

3.2.1 External Fixation and Two-Stage Treatment Protocol

• Patients with distal tibial fractures are recommended to have external fixation devices applied for temporary or definitive fragment fixation according to the following indications:

• open distal tibial fracture type Gustilo-Anderson II, IIIA-C;

• displaced distal tibial fracture as part of multiple and polytrauma, as a method of temporary fracture fixation;

• in complex comminuted fractures of the distal tibia as a method of primary reduction and temporary fixation in the presence or anticipated significant soft tissue edema, as a preparation method for definitive internal osteosynthesis;

• in distal tibial fractures of any complexity as a method of definitive stabilization at the surgeon's individual preference [21, 23, 48, 101, 93, 121].

GCR ALoE 2Grade of Recommendation A (Level of Evidence – 2).

Comments: The use of an external fixation device (EFD) as a method for temporary stabilization of a distal tibia fracture followed by conversion to definitive internal osteosynthesis after normalization of the patient's general condition and soft tissue status is a generally accepted approach referred to in modern literature as the "two-stage protocol". The goal of the primary stage is to restore the axis and length of the leg segment, correct rotational displacement of fragments, and eliminate gross displacement of articular surface fragments through ligamentotaxis, which reduces the likelihood of critical soft tissue ischemia in the fracture zone. For primary surgical stabilization, basic EFD configurations are used as temporary fixators. Traditional convenient configurations include bilateral EFD assemblies from the military field rod kit (KSVP) and a kit of components and parts for an external fixation device with an installation tool, with pins inserted into the upper third of the tibial diaphysis, the calcaneus, talus, or the 1st and 5th metatarsal bones, connected by tubes in the shape of an inverted letter "V". The duration of fixation in the EFD ranges from 10 to 21 days. The timing of conversion to internal osteosynthesis is determined by the resolution of edema, the appearance of "wrinkles" on the skin of the foot and ankle joint, epithelialization of blisters, or wound healing in open fractures [9, 21, 29, 48].

• In patients with distal lower leg fractures, primary single-stage osteosynthesis of the fibula during the placement of a primary stabilizing EFD is not recommended, as this may limit the choice of surgical approach for osteosynthesis of the distal tibial metaphysis and complicate the reconstruction of the latter's articular surface if fibular reduction is performed incorrectly [73, 108, 93, 121].

  Recommendation Grade B (Evidence Level – 3).

Comments: As a method of definitive fracture stabilization, circular or hybrid EFDs are preferred (military field rod kit KSVP, kit of components and parts for the external fixation device with its installation tool). To increase their stability and to reduce intra-articular fragments, the use of wires with stopper ends (orthopedic bone wire***) is recommended. In a number of clinical cases, with poor soft tissue condition and skin defects or according to the surgeon's preference, it is possible to combine limited open reduction of intra-articular fracture fragments with their fixation by individual 3.5 mm cortical screws, 4.0 mm cancellous screws, cannulated screws (orthopedic bone screw, non-absorbable, non-sterile***, orthopedic bone screw, non-absorbable, sterile***), or mini-plates (bone plate for fracture fixation with screws, non-absorbable, sterile***, bone plate for fracture fixation with screws, non-absorbable, non-sterile***), followed by osteosynthesis with an external fixation device. The fixing elements of the EFD into the lower leg and foot must be placed taking into account the anatomical features of the leg segment, "safe zones", and the topography of vessels, nerves, muscles, and tendons of the segment. The duration of fixation in the EFD in this case is determined by the time of tibial fracture healing [23, 38, 47, 70, 90, 96, 112].

Pediatric considerations: the use of external fixation devices in children is performed for similar indications. Both rod and circular (wire) external fixation devices can be used. It is recommended to avoid placing support elements transphyseally [93, 121].

3.2.2. Plate osteosynthesis

• In patients with distal lower leg fractures, plate osteosynthesis is recommended during the surgical treatment of distal tibial fractures to create conditions for fracture consolidation [12, 15, 21, 48, 101, 93, 121].

LE AQOE 3Level of Evidence A (reliability of evidence level – 3).

Comments: When performing plate osteosynthesis of distal lower leg fractures, the following implants are used: bone plate for fracture fixation with screws, non-absorbable, sterile***, bone plate for fracture fixation with screws, non-absorbable, non-sterile***, orthopedic bone screw, non-absorbable, sterile***, orthopedic bone screw, non-absorbable, non-sterile***.

For quality preoperative planning, it is recommended to distinguish the following stages of internal plate osteosynthesis of a distal lower leg fracture:

• reconstruction of the articular surface;

• fixation of the diaphyseal fragment;

• osteosynthesis of the fibula;

• closure of surgical wounds.

Reconstruction of the articular component of the fracture requires an adequate surgical approach or a combination thereof, and is often performed using a distractor. Fragment reduction is carried out in a specific sequence depending on the individual architectonics of the fracture, using a combination of direct and indirect reduction methods with joysticks, bone holding forceps, Kirschner wires, lag screws, and plate-assisted reduction. Reduction is performed under visual and fluoroscopic control. Restoration of the articular surface anatomy frequently requires bone grafting to fill subchondral bone defects. Preliminary fixation can be performed using Kirschner wires (orthopedic bone wire***). Final fixation of the articular component should be performed according to the principle of absolute stability, achieving anatomic reduction and interfragmentary compression of the articular surface fragments. During osteosynthesis of the metaphyseal component of the fracture, it is sufficient to restore only the axis and length of the segment and correct rotational displacement of the fragments. Anatomic reduction of the metaphyseal component of the fracture is possible, but requires broader surgical approaches, is more traumatic, and is associated with a higher rate of postoperative complications [9, 12, 15, 21, 48].

Pediatric considerations: plate fixation for distal lower leg fractures is possible if there is a sufficient length of the metaphyseal fragment to position the plate proximal to the growth plate (metaphyseal and diaphyseal fractures). In transphyseal fractures, the use of plates is limited; for diaphyseal fractures, the optimal fixation method is elastic titanium nails (intramedullary nails and rods: flexible intramedullary nail).

• In patients with distal lower leg fractures, the following surgical approaches are recommended for performing osteosynthesis of distal lower leg fractures, depending on the fracture architectonics, soft tissue status, and the surgeon's individual preferences:

• medial approach is most commonly used in minimally invasive osteosynthesis techniques for periarticular fractures and minimally displaced fractures, when there is no need to expose the anterior pilon fragments and visualize them openly;

• anteromedial approach is indicated for varus deformation of the fracture zone with predominant damage to the medial column of the pilon, when placement of a distal medial buttress plate is required;

• anterolateral approach provides good exposure of the lateral column, allows open reduction of the lateral and anterior fragments of the tibial articular surface, is preferred for fractures with valgus deformation, and is convenient for placing an anatomic anterolateral plate;

• lateral approach is indicated for fibular osteosynthesis, reduction and fixation of the Tillaux–Chaput fragment, and also provides visualization of the anterior tibiofibular ligament;

• posterolateral approach is used to directly access the posterolateral fragment of the pilon (Volkmann’s fragment);

• posteromedial approach also allows access to the posterior column of the pilon and direct open reduction thereof [3, 9, 12, 21].

GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).

Comments: The use of anterior and posterior approaches is recommended both separately for injuries of the anterior or posterior column [3, 44, 50, 94, 95], and in combination for complex comminuted pilon fractures. The use of a combination of approaches for visualization and direct reduction of the anterior and posterior parts of the pilon during a single operative session is recommended [73, 108]. Each selected approach must be minimally sufficient in length for inspection and manipulation of fragments while remaining minimally traumatic and sparing to the soft tissues. When using multiple surgical approaches, one should take into account the need to preserve soft tissue blood supply and, to prevent complications associated with tissue ischemia between the approaches, maintain a soft tissue bridge of at least 7 cm between the surgical approaches [68, 69, 119]

If open reduction and internal fixation of a pilon fracture using two approaches was initially planned, but during the first stage of surgery through the first approach a significant increase in soft tissue edema is noted, the execution of the second surgical approach may be postponed for 5–10 days until the edema subsides. Otherwise, a situation may arise where skin wound closure is impossible or can only be achieved under high tension, leading to marginal wound necrosis. Fracture immobilization in the interval between stages can be performed using one of the standard methods (external fixation device, plaster cast, skeletal traction) [12, 21].

In cases of comminuted intra-articular fractures, the use of a combination of plates with support for all damaged columns of the distal tibial metaphysis is recommended. [20, 24, 55, 57, 58].

Pediatric considerations: when performing surgical approaches to fractures, extensive skeletonization of fragments with damage to growth plates is not recommended to avoid premature closure of growth plates and the development of secondary deformities.

• In patients with distal lower leg bone fractures it is recommended to use autologous bone, allogeneic bone, and synthetic bone substitutes to bridge bone defects of the distal tibial metaphysis [17].

GPP BLOE 3Grade of Recommendation B (Level of Evidence – 3).

Comments. Bone defect reconstruction can be performed during the internal osteosynthesis stage in comminuted tibial fractures or in a delayed manner, depending on the specific clinical situation and the decision of the operating surgeon [17].

• In patients with distal lower leg bone fractures to minimize surgical trauma and create conditions for fracture healing it is recommended to use minimally invasive plate osteosynthesis techniques by placing plates through distal surgical approaches to the articular component of the fracture and proximal fixation through separate mini-incisions in extra-articular and simple intra-articular fractures of the distal tibia where the articular component is absent or anatomical reduction of the articular surface can be achieved without fragment exposure [12, 48, 88].

LE AQOE 3Level of Evidence A (reliability of evidence level – 3).

Comments. In simple intra-articular fractures (type 43-C1, 43-C2) it is recommended to first perform closed reduction of the articular fragment using bone holding forceps and fix them with lag screws, followed by minimally invasive insertion of a buttress plate. In complex intra-articular fractures (type 43-C3), a combination of limited open reduction of the articular component of the fracture and minimally invasive fixation of the diaphyseal fracture fragment is recommended to reduce operative wound length, minimize surgical trauma, and optimize healing processes [7, 12, 48, 62, 66, 75, 88].

• In patients with distal lower leg bone fractures it is recommended to use intraoperative fluoroscopic imaging during plate osteosynthesis of pilon fractures to monitor fragment reduction and implant positioning [12, 101, 115, 119, 120, 121].

LE AQOE 3Level of Evidence A (reliability of evidence level – 3).

• In patients with distal lower leg bone fractures it is recommended to perform osteosynthesis of the fibula when combined with a distal tibial fracture to create conditions for fracture healing according to the following indications:

• post-traumatic varus/valgus deformity of the leg and the presence of lateral instability of bone fragments after reduction and fixation of intra-articular comminuted pilon fractures [108].

GPP BLOE 3Grade of Recommendation B (Level of Evidence – 3).

Comments. An intraoperative valgus stress test is recommended to verify lateral ankle instability and establish intraoperative indications for fibular fixation. Fibular osteosynthesis should be performed through the same approach used for tibial pilon osteosynthesis. In cases of a comminuted fibular fracture, it is advisable to use a minimally invasive fixation method without wide exposure of the fibular fracture zone [108].

Depending on the surgeon's individual preference, intramedullary osteosynthesis of the fibula may be used in certain clinical situations [21].

In cases of primary varus deformity of the segment and a simple fibular fracture pattern, its osteosynthesis may be performed, but can be omitted to reduce surgical trauma and minimize the risk of potential complications [108].

• In patients with distal lower leg bone fractures it is recommended to assess the condition of the distal tibiofibular syndesmosis (DTFS) when there is evidence of its injury (up to 15% in pilon fractures) and to fix the DTFS using traditional methods (position screw, ligament fixation system – endobutton) in the presence of persistent valgus instability detected intraoperatively after fibular fixation, in order to increase fixation stability [41, 64, 108].

Pediatric considerations: evaluation of stability and the need for stabilization of the DTFS in children is performed after osteosynthesis of the tibia and fibula.

GPP BLOE 3Grade of Recommendation B (Level of Evidence – 3).

• In patients with distal lower leg bone fractures during the closure of postoperative wounds in the distal lower leg area it is recommended to use a technique that ensures adequate wound edge adaptation with minimal trauma (cosmetic epidermal suture, Allgöwer suture) to reduce the risk of complications [12, 21].

GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).

Comments. In some cases, when wound closure without skin flap tension is impossible and there is an increased risk of postoperative skin necrosis, delayed suture placement or plastic wound coverage methods are indicated. The medial wound should preferably be closed, while the skin defect of the lateral or posterolateral surface can be covered with a split-thickness skin graft [12, 21].

3.2.3. Intramedullary Nailing

• In patients with distal lower leg bone fractures it is recommended to use intramedullary osteosynthesis for distal tibial fractures to create conditions for fracture healing under the following restricted indications:

• extra-articular tibial fractures;

• distal tibial fracture extending to or combined with a fracture of the tibial diaphysis or proximal tibia;

• simple intra-articular tibial fracture provided prior osteosynthesis of the distal metaphysis with lag screws has been performed;

• individual surgeon preference;

• special clinical cases [12, 15, 21].

GPP BLOE 3Grade of Recommendation B (Level of Evidence – 3).

Comments. When performing intramedullary osteosynthesis for distal lower leg bone fractures, the following implants are used: tibial intramedullary nail, sterile***; tibial intramedullary nail, non-sterile***; orthopedic bone screw, non-absorbable, sterile***; orthopedic bone screw, non-absorbable, non-sterile***.

The use of intramedullary osteosynthesis has limited indications in the surgical treatment of distal tibial fractures. In such cases, special designs of intramedullary nails allowing multiplanar distal locking should be used, and the length, diameter, and specific model of the nail should be carefully selected to achieve sufficient fracture fixation stability [12, 15, 21].

Pediatric considerations: locked intramedullary nailing in children is recommended after growth plate closure. When growth plates are open and the fracture is located in the diaphyseal or metadiaphyseal region, titanium elastic nails are the optimal method to achieve adequate stabilization.

3.2.4. Primary ankle arthrodesis

• In patients with distal lower leg bone fractures it is recommended to perform primary ankle arthrodesis during early surgical treatment of distal lower leg fractures to achieve bone union in the following clinical situations:

• severe comminuted intra-articular pilon fracture with significant impression and destruction of the tibial articular surface when anatomical reduction of the articular surface is impossible

• distal tibial fractures with an existing bone defect of the tibial articular surface

• special clinical cases [4, 21].

Comments. Ankle arthrodesis can be performed using a circular external fixation frame (military field rod set KSVP, set of components and parts for an external fixation device with an installation tool), plate-and-screw internal fixation (non-absorbable sterile bone fracture fixation plate with screws***, non-absorbable non-sterile bone fracture fixation plate with screws***, non-absorbable sterile orthopedic bone screw***, non-absorbable non-sterile orthopedic bone screw***), or intramedullary nailing (sterile intramedullary arthrodesis nail***, non-sterile intramedullary arthrodesis nail***, non-absorbable sterile orthopedic bone screw***, non-absorbable non-sterile orthopedic bone screw***), depending on the specific clinical situation and the surgeon's preference [4, 21].

Pediatric considerations: primary ankle arthrodesis in children with open physes is significantly limited and requires an individualized assessment of indications, contraindications, and risk levels.

3.3 Other Treatment

3.3.1. Postoperative analgesia

• For adequate pain relief in patients with distal tibial articular fractures, it is recommended to use multimodal analgesia, which may include NSAIDs (from group M01A Anti-inflammatory and antirheumatic products, non-steroids), paracetamol**, gabapentinoids (ATC group code N02BF), and immediate-release opioids (ATC group code N02A) taking into account the age restrictions in the instructions for medical use, or monomodal analgesia if multimodal approach cannot be prescribed [27, 92, 97].

GoR ALoE 2Grade of Recommendation A (Level of Evidence – 2).

Comments: It is necessary to ensure adequate analgesia for the patient with a fracture prior to any manipulations and throughout the entire period of fracture treatment, the duration of which varies significantly depending on the chosen management strategy. When performing analgesia in a hospital setting, it is necessary to take into account prescriptions made at the emergency medical care stage. In the acute period of trauma, for the purpose of analgesia, it is necessary to ensure proper immobilization of fragments using a vacuum splint, a vacuum mattress, or an external fixation device.

Among pharmacological strategies, the current consensus is to use multimodal analgesia (MMA), which involves the combination of several analgesic drugs (opioid and non-opioid) of group N02 with different mechanisms of action, along with non-pharmacological interventions targeting the peripheral and/or central nervous system [46]. This combination provides more effective pain control by enhancing the effects of various drugs, which in most cases leads to a reduced frequency of prescriptions and/or lower doses of opioid analgesics. Thus, MMA improves the risk profile of each drug while ensuring synergistic pain control through different drug classes. Postoperative MMA may include psychotherapy, physical therapy, NSAIDs, paracetamol**, gabapentinoids, regional anesthesia (single-shot or peripheral nerve catheters), local injections, and opioids [97].

Current scientific literature emphasizes the use of the lowest effective doses of opioids for the shortest possible duration, avoiding extended-release opioids. As an adjuvant during MMA in adult patients, a single intravenous dose of #dexamethasone** 1.25–20 mg can be administered preoperatively (60 minutes before the incision), which significantly reduces pain [92].

It must be kept in mind that parenteral administration of most NSAIDs (ketorolac**, ketoprofen**, diclofenac**) is limited to two days in accordance with the age restrictions in the instructions for medical use, which requires timely transition of the patient to oral administration, changing the drug, or approving further use by a medical commission. The specific choice of local anesthesia method and medicinal products is made by the attending physician individually in accordance with the patient's characteristics, local protocols, and the equipment of the medical organization.

When prescribing analgesic therapy for children, a single dose should be chosen taking into account the child's weight and age. Preference should be given to analgesics with oral or rectal administration routes, avoiding intramuscular injections.

Recommended analgesic medications of group N02 are provided in Appendices A3.1 and A3.2.

Pediatric considerations: analgesic therapy in children is determined by the severity of pain, the child's age, and age-related contraindications for certain analgesic drugs of group N02. Continuous peripheral nerve block can be used for adequate pain relief.

Dosage regimens for analgesics in children in accordance with the instructions for medical use are provided in Appendix A3.3.

3.3.2. Perioperative antibiotic prophylaxis

• In the surgical treatment of patients with distal tibial articular fractures, it is recommended to perform surgical antibiotic prophylaxis (SAP) of surgical site infections by a single preoperative administration of an antibacterial drug to reduce the risk of infectious complications [10, 12].

GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5).

Comments. In accordance with international clinical guidelines for the prevention of surgical site infections [10, 117] the goal of SAP is to achieve bactericidal concentrations of the antibacterial drug in tissues exposed to microbial contamination during surgery to prevent surgical site infections. The need for SAP is determined by the surgical wound class of the upcoming operation: SAP is not required for "clean" surgical wounds not involving the placement of orthopedic implants and metal hardware. SAP should be performed: for clean-contaminated and contaminated surgical wounds; for "clean" surgical wounds where orthopedic implants and metal hardware are implanted. For infected ("dirty") wounds, SAP is not indicated; antibiotic therapy is administered instead.

• In patients with distal tibial articular fractures, it is recommended to use first- and second-generation cephalosporins (cefazolin**, cefuroxime**) as the primary drugs for surgical antibiotic prophylaxis during trauma and orthopedic surgeries, with glycopeptide antibiotics (vancomycin**) or lincosamides (#clindamycin**) serving as alternatives in case of beta-lactam allergy [10].

GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5).

Comments._For patients with an unremarkable allergy history and no significant risk factors for methicillin-resistant Staphylococcus carriage, first- and second-generation cephalosporins (cefazolin**, cefuroxime**) are used for SAP, administered intravenously 30 to 60 minutes before the skin incision. In case of beta-lactam hypersensitivity a combination of vancomycin** with one of the fluoroquinolones (ciprofloxacin**, #levofloxacin**) administered over at least 60 minutes starting the intravenous infusion 2 hours before the incision, or #clindamycin** should be prescribed. In the presence of significant risk factors for methicillin-resistant Staphylococcus (MRS) carriage, the SAP regimen should include systemic antibacterial drugs (J01A) with anti-MRS activity (vancomycin**). In most cases, a single preoperative dose of the antibiotic is sufficient for effective prophylaxis. For prolonged procedures or massive blood loss, an additional intraoperative dose of the antibiotic should be administered (the approximate timing of intraoperative administration is two half-lives after the preoperative dose). Administering an antibiotic after wound closure in the operating room is impractical even in the presence of inserted drains.

Single doses of the main antibacterial drugs for SAP in adult trauma and orthopedic surgeries: cefazolin** 2 g (if patient weight ≥120 kg — 3 g), cefuroxime** 1.5 g, #clindamycin** 900 mg, vancomycin** 15 mg/kg as a slow IV infusion, ciprofloxacin** 400 mg, #levofloxacin** 500 mg [10]. Single doses for children should be calculated based on actual weight: cefazolin** 30 mg/kg, cefuroxime** 50 mg/kg, #clindamycin** 10 mg/kg, vancomycin** 15 mg/kg; the use of fluoroquinolones during the period of musculoskeletal system development is contraindicated due to the risk of arthropathy [124, 125].

Comments. In open fractures, prophylactic administration of antibiotics is effective in preventing early infection, and the drug should be administered as soon as possible after trauma. Cefazolin** is the antibiotic of choice; however, in patients with open high-energy fractures with displacement and segmental bone loss; major vascular injury, and severely contaminated wounds, it is advisable to broaden the spectrum of administered antibiotics to cover Gram-negative pathogens. In such cases, adult patients may be considered for the addition of #gentamicin# (at a dose of 6 mg/kg once daily) to cefazolin** [45, 83]. An alternative to this combination may be #ampicillin+sulbactam** (at a dose of 3.0 g every 8 hours for 3 days) [85], the latter being particularly relevant in case of the risk of clostridial infection. According to most researchers, in Gustilo and Anderson type III open fractures, antibiotics should not be continued for more than 72 hours after soft tissue wound closure [71].

• In the surgical treatment of patients with lower limb bone fractures, it is recommended to perform antimicrobial prophylaxis of surgical site infection lasting no more than 24 hours [104].

GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5).

Comments. In accordance with the regulatory documentation in force in the Russian Federation (SanPiN 3.3686-21) and clinical guidelines [104], to achieve an effective concentration of the antibacterial drug in tissues and blood serum at the time of the skin incision, antibiotics for the prevention of surgical site infection should be administered intravenously within 30 to 60 minutes before the skin incision, or within 2 hours before the incision when using vancomycin**. The maximum duration of prophylactic antibiotic administration should not exceed 24 hours after the completion of the surgery. In most cases, a single dose of the antibiotic is sufficient for effective prophylaxis. Additional doses should be administered during prolonged surgeries when the half-life of the administered antibiotic elapses from the moment of preoperative administration, creating a risk of the antibiotic concentration dropping below the bactericidal level and increasing the risk of surgical site infection.

Pediatric considerations: perioperative antimicrobial prophylaxis in children with lower leg bone fractures consists of administering first- and second-generation cephalosporins (cefazolin**, cefuroxime**) taking into account age restrictions for children, no later than 30 minutes before the start of the surgical procedure (in case of allergic reactions, the choice of a broad-spectrum antibiotic is made individually). The choice of drug for antibiotic therapy is determined by the child's age, severity of condition, and microorganism susceptibility [124, 125].

3.3.3. Prevention of venous thromboembolic complications

Comments: Patients with lower limb bone fractures may belong to the moderate or high-risk group for VTEC development, depending on patient characteristics, the nature of the sustained trauma (multiple and polytrauma have a higher risk of DVT), and the duration of the planned surgery.

To assess the patient's risk of developing VTEC before surgery, it is advisable to use the Caprini risk assessment scoring scales for VTEC development (Appendix G1). For all patients with limited mobility, regardless of the determined VTEC risk level, mechanical VTEC prophylaxis is recommended [102].

Non-pharmacological means of VTE prophylaxis include:

• elastic and/or intermittent pneumatic sequential compression of the lower extremities;

• early mobilization and activation of the patient;

• physiotherapy.

Along with mechanical VTEC prophylaxis, patients with a moderate or high risk of VTEC are recommended to undergo pharmacological VTEC prophylaxis, as a rule, until the patient's normal or expected mobility is restored [102].

• In all patients with lower limb bone fractures and subsequent osteosynthesis in the absence of active bleeding, it is recommended to perform VTEC prophylaxis until the patient's normal or expected mobility is restored [56, 59].

Level of Recommendations B (Level of Evidence 2)Level of Evidence 2Level of Recommendations B (Level of Evidence 2).

Comments: Preoperative pharmacological VTEC prophylaxis is performed with unfractionated heparin (UFH) of the B01AB group or, preferably, low-molecular-weight heparins (LMWH) of the B01AB group (Appendix A3.3). Vitamin K antagonists may also be used when determining the international normalized ratio (INR) [102].

• For patients chronically receiving antithrombotic agents  of group B01 and admitted with a distal lower extremity fracture, it is recommended to perform VTE prophylaxis and anesthesia based on relevant guidelines in order to prevent complications [105, 110].

GGR BLOC 3Grade of recommendation B (Level of evidence 3).

• In patients with lower limb bone fractures undergoing conservative treatment and limb immobilization, it is recommended to initiate VTEC prophylaxis immediately after bleeding is ruled out, with the aim of preventing complications [102].

GGR BLOC 3Grade of recommendation B (Level of evidence 3).

Comments. According to Metz et al. [72] there is insufficient evidence to recommend routine VTE prophylaxis in outpatients with below-knee or lower leg immobilization following an isolated lower leg injury because the incidence of symptomatic VTE is too low. Current ACCP guidelines suggest no VTE prophylaxis rather than pharmacological VTE prophylaxis in patients with isolated lower leg injuries requiring leg immobilization [32].

Recommended medicinal products and regimens for thromboprophylaxis in adults are provided in Appendix A3.4.

Issues of VTE prophylaxis in trauma and orthopedic patients are discussed in detail in the 2022 guidelines [102] and the 2023 Russian expert guidelines [110].

Pediatric age specifics: specific measures for thromboprophylaxis in children with traumatic injuries are absent due to their low incidence. Important criteria for performing thromboprophylaxis include a history of thrombosis and thromboembolism, blood coagulation disorders, and placement of a central venous catheter [91].

3.3.4. Blood-conserving technologies

Comments. Tranexamic acid** effectively reduces blood loss and leads to a smaller decrease in postoperative hemoglobin levels in patients undergoing surgery for distal lower extremity fractures. Randomized clinical trials demonstrate the efficacy of local subfascial administration of #tranexamic acid** (1.0 g in 10 ml) into the postoperative wound area, comparable to intravenous administration of an equivalent dose of the drug [35, 128].

Comments. Systematic reviews and meta-analyses demonstrate that perioperative use of intravenous iron preparations, specifically ferric carboxymaltose**, in trauma and orthopedic patients, especially in the postoperative period, is an effective alternative to blood transfusion, as it reduces the proportion of patients who underwent blood transfusion, decreases the volume of red blood cell mass transfused, leads to a lower incidence of infectious complications, but does not result in a change in mortality [52, 80].

Evidence has been obtained in the pediatric population regarding the efficacy of intravenous iron preparations for correcting iron deficiency anemia in the preoperative period during elective orthopedic procedures [126, 127]. Data on the use of these drugs in children in the postoperative period following trauma surgery are absent.

3.3.5. Tetanus prophylaxis

Comments: In accordance with clauses 4156-4157 of the Sanitary Rules and Norms for the Prevention of Infectious Diseases (SanPiN 3.3686-21), emergency tetanus prophylaxis is performed for any injuries with a breach of integrity of the skin and mucous membranes. Emergency tetanus prophylaxis is performed up to the 20th calendar day from the moment of injury [116]. The prescription of drugs for emergency tetanus immunoprophylaxis is carried out differentially depending on the presence of documentary confirmation of vaccination or data from immunological monitoring of anti-tetanus immunity levels, as well as taking into account the nature of the injuries.

Emergency tetanus immunoprophylaxis is carried out in the form of:

• passive immunization or seroprophylaxis with human tetanus immunoglobulin** (HTIG), and in its absence, with tetanus antitoxin** (TAT);

• active-passive prophylaxis, consisting of the simultaneous administration into different anatomical sites of human tetanus immunoglobulin** (or in its absence, TAT) and tetanus toxoid** (TT);

• emergency revaccination with tetanus toxoid** (or diphtheria-tetanus toxoid with reduced antigen content** - Td-toxoid) to stimulate immunity in previously vaccinated individuals. [63, 116]

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Comments: Depending on the location and nature of the fracture, the technique of fragment reposition is determined, followed by fracture fixation with a plaster cast up to the middle third of the thigh for a period of 3-4 months. After consultation with a medical rehabilitation physician / physical therapy physician, a rehabilitation program is drawn up in accordance with the general principles of the immobilization period: dynamic exercises for the healthy limbs, isometric exercises for the muscles under the plaster cast, ideomotor movements for the knee and ankle joints, and self-assisted movements for the hip joint are prescribed. Training in locomotion with assistive mobility devices is carried out [34, 100, 111].

Pediatric features: taking into account the specifics of bone fracture consolidation rates in children, the periods of immobilization can vary from 3 weeks to 3 months depending on the degree of consolidation according to radiographs, as well as clinical evaluation data.

Comments: after removal of the plaster cast, the medical rehabilitation physician / physical therapy physician draws up a rehabilitation program prescribing physical therapy (exercise therapy) and physiotherapy: dynamic exercises for healthy limbs, assisted movements in the knee and ankle joints, basic mechanotherapy, passive mechanotherapy for the knee and ankle joints, physical exercises in water, positioning therapy, soft tissue stretching exercises, manual and/or hardware lymphatic drainage, manual and/or underwater massage of the leg [1, 5, 65, 76].

Physiotherapy methods include local cryotherapy, low-frequency pulsed electromagnetic field therapy, and ultrasound therapy for joint diseases.

Two weeks after the follow-up consultation with a medical rehabilitation physician/exercise therapy physician, provided there is sufficient mobility of the knee and ankle joints, the following are prescribed: robot-assisted mechanotherapy for bone fractures, pneumatically (electrically) powered mechanotherapy devices, exercise therapy for bone fractures (dynamic exercises with resistance and weights, static exercises), biofeedback-assisted exercise therapy for joint diseases and injuries, balance therapy, and biofeedback-based weight-bearing training for joint diseases and injuries. Training in walking without weight-bearing on the leg and with partial weight-bearing is performed. Considering the intra-articular nature of the fracture, full weight-bearing and gait training begin at 4 months post-fracture [42, 53, 91].

Comments: starting from the first postoperative day, in accordance with the performed surgical intervention, an individualized rehabilitation program is prescribed: postoperative exercise therapy for bone fractures (breathing exercises, active exercises for the joints of the healthy limb, assisted and self-assisted exercises for the hip, knee, and ankle joints of the operated leg, isometric exercises for the gluteal muscles, thigh and lower leg muscles of the operated limb). For the ankle joint, mechanotherapy using pneumatic- or electric-powered devices for joint injuries and diseases, and positioning correction are prescribed. There is no single rehabilitation protocol; an individualized approach is emphasized in selecting rehabilitation tools and methods based on the mechanisms of action of physical exercises, massage, and physiotherapy methods [1, 5, 67, 91, 100]. To prevent local complications—reducing soft tissue edema and creating optimal anatomical and physiological conditions for the healing of tissues traumatized during surgery—local cryotherapy, alternating magnetic field therapy, low-level laser therapy, and ultraviolet therapy are prescribed. [65].

Gait training using a walker and subsequently, depending on the patient's condition, using two crutches without weight-bearing on the leg is initiated from the first days after surgery [12, 28].

Comments: in patients with distal tibia/fibula fractures after “stable” osteosynthesis, active movements in the ankle joint are performed from the first days after surgery and continue at this stage until normal range of motion is achieved. The question of axial weight-bearing on the lower limb is decided individually, based on the dynamics of fracture union [12, 15, 21, 119, 120]. The literature notes the positive role of physical exercise and a statistically significant improvement in treatment outcomes with a reduction in postoperative complications when rehabilitation is carried out from the first days after surgery until final results are achieved [1, 65, 67, 76]. The rehabilitation program includes postoperative therapeutic exercise (exercises to strengthen the thigh, lower leg and foot muscles; resistance exercises, exercises with additional weight, static exercises). Robotic mechanotherapy is prescribed, as well as mechanotherapy on electrically/pneumatically driven mechanotherapy devices for bone fractures, biofeedback training on support reaction in fractures, and balance therapy. Therapeutic exercise is combined with manual massage of the foot and lower leg, and physiotherapy methods: electrophoresis of medications for joint diseases, interferential current therapy, high-frequency electromagnetic field exposure (inductothermy), and ultrasound therapy for joint diseases [1, 65, 67, 76].

In the presence of radiological signs of fracture healing 3–4 months after surgery, weight-bearing on the leg and gait training are permitted [42, 53, 67, 91].

5. Prevention and Dispensary Observation

Prevention of distal lower leg fractures consists of citizens observing social safety rules during household chores, staying in vehicle traffic zones, engaging in sports, walking on poor surfaces, and during icy conditions.

A significant share of responsibility in fracture prevention also belongs to state structures, which are obliged to ensure safety to prevent road traffic injuries, as well as ensure compliance with safety regulations in industries with increased risk of trauma.

Comments: After discharge from the inpatient facility, the patient should be referred to an outpatient trauma center or orthopedic clinic, indicating the treatment performed and providing detailed recommendations for ongoing treatment and rehabilitation. This ensures continuity between inpatient and outpatient stages of care.

Follow-up examinations with X-rays (lower limb radiography) and assessment of functional recovery dynamics are performed at 6 weeks postoperatively (assessment of fracture healing progress, implant position), 12 weeks postoperatively (assessment of fracture healing progress and weight-bearing capability), 24 weeks postoperatively (assessment of healing progress and functional recovery dynamics), and 1 year postoperatively (assessment of functional treatment outcomes and determining the necessity and timing of implant removal).

Pediatric considerations: fractures involving growth plates require dynamic monitoring with follow-up X-rays at 6–12 months post-fracture (and further as needed) for the timely diagnosis of premature physeal closure.

6. Organization of Medical Care

Clinical application of recommendations: Traumatology and Orthopedics, Anesthesiology and Intensive Care, Medical Rehabilitation, Health Organization and Public Health.

The aim of the clinical guidelines: The clinical guidelines have been developed to improve the quality of medical care, standardize diagnostic algorithms, and treatment of patients with malleolar fractures.

Indications for planned hospitalization:

• presence of a displaced distal lower leg fracture identified during follow-up examinations by an outpatient traumatologist;

• unsatisfactory result of conservative treatment (secondary displacement of fragments, absence of signs of fracture union); secondary displacement or migration of implants following osteosynthesis surgery [11, 15, 21, 119, 120].

Indications for emergency hospitalization:

Patients with suspected or confirmed distal lower leg fracture must be referred to an inpatient facility to determine the need for emergency hospitalization. Indications for emergency hospitalization include:

• distal lower leg fracture with fragment displacement;

• open distal lower leg fracture;

• gunshot fracture of the distal lower leg region;

• distal lower leg fracture accompanied by major vascular and nerve injuries;

• distal lower leg fracture as part of polytrauma [11, 15, 21, 119, 120].

Indications for emergency hospitalization for a distal lower leg fracture are determined based on:

1. presence of symptoms characteristic of a distal lower leg fracture in the patient;

2. presence of characteristic clinical signs of a distal lower leg fracture;

3. presence of radiographic signs of a distal lower leg fracture in the patient.

Indications for patient discharge from the hospital:

1. Internal fixation of the fracture with hardware or stabilization with an external fixation device has been performed, or adequate plaster immobilization has been achieved during conservative treatment.

2. The first stage of rehabilitation has been completed.

3. There is no acute infectious process.

4. Refusal of the patient or their legal guardians in case of legally established incapacity of the patient to continue inpatient treatment (the reason for refusal must be recorded in the medical chart with the personal signature of the patient or their guardians).

7. Additional Information

No additional information is required.

Criteria for Evaluating the Quality of Medical Care

References

Appendix A1. Working Group Composition

1. Belenky I.G., MD, DSc, Associate Professor, Saint Petersburg I.I. Janelidze Research Institute of Emergency Medicine, Saint Petersburg, member of ATOR

2. Sergeev G.D., PhD, Saint Petersburg Dzhanelidze Research Institute of Emergency Medicine, St. Petersburg, member of ATOR

3. Mayorov B.A., Candidate of Medical Sciences, St. Petersburg I.I. Janelidze Research Institute of Emergency Medicine, Pavlov First Saint Petersburg State Medical University, St. Petersburg, member of ATOR

4. Bozhkova S.A., Doctor of Medical Sciences, Vreden National Medical Research Center of Traumatology and Orthopedics of the Russian Ministry of Health, St. Petersburg, member of ATOR.

5. Kleymenova E.B., MD, Professor, Federal State Budgetary Institution "N.N. Priorov National Medical Research Center of Traumatology and Orthopedics" of the Russian Ministry of Health, Moscow.

6. Geroyeva I.B., MD, Professor, Federal State Budgetary Institution "N.N. Priorov National Medical Research Center of Traumatology and Orthopedics" of the Russian Ministry of Health, Moscow.

7. Otdelevonov V.A., Candidate of Medical Sciences, N.N. Priorov National Medical Research Center of Traumatology and Orthopedics of the Russian Ministry of Health, Moscow

8. Kenis V.M., Doctor of Medical Sciences, G.I. Turner National Medical Research Center for Children's Orthopedics and Trauma of the Russian Ministry of Health, St. Petersburg

9. Sapogovsky A.V., Candidate of Medical Sciences, G.I. Turner National Medical Research Center for Children's Orthopedics and Trauma of the Russian Ministry of Health, St. Petersburg

Conflict of interest.

The working group for writing these clinical guidelines has no conflict of interest.

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience for these clinical guidelines:

1. Orthopedic trauma surgeons

2. Surgeons

3. General practitioners (family physicians)

4. Medical rehabilitation physicians

5. Healthcare organization and public health specialists.

Stages of evaluating the levels of evidence and grades of recommendation:

1. Definition of search and selection criteria for publications on clinical trials (CT) regarding the efficacy and/or safety of the medical intervention described in the recommendation statement.

2. Systematic search and selection of CT publications in accordance with the previously defined criteria.

Systematic search and selection of clinical trial publications:

The evidence base for the recommendations consisted of publications retrieved via information retrieval in the following databases: Central Scientific Medical Library (CSML) "Russian Medicine", MEDLINE (US NLM), and COCHRANE Library; scientific electronic libraries eLibrary.ru and "CyberLeninka"; as well as on the Internet using Yandex, Google, and Google Scholar search engines, by reviewing leading specialized peer-reviewed domestic medical journals on the subject and treatment guidelines for fractures from the international Association for Osteosynthesis AO/ASIF.

Table 1. Levels of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)

Table 2. Scale for grading levels of evidence (LE) for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)

Table 3. Scale for grading grades of recommendation (GR) for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitative interventions)

Procedure for updating clinical guidelines.

The mechanism for updating clinical guidelines provides for their systematic revision — at least once every three years, as well as upon the emergence of new evidence-based medicine data regarding the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.

Appendix A3. Reference Materials

Appendix A3.1. Recommendations for pain management in major musculoskeletal trauma (surgical interventions for long bone fracture fixation or complex articular fracture, extensive soft tissue trauma, major surgery, etc.) in adults

Appendix A3.2. Recommendations for pain management in non-surgical musculoskeletal trauma (closed fractures, superficial wounds, etc.) in adults

Appendix A3.3 Dosing regimen of painkillers for children

¹ In children under 12 years of age, morphine** is preferred when opioid analgesics need to be prescribed, as the use of tramadol** is associated with a higher risk of adverse reactions [129, 130].

² Use in children is not recommended because its metabolite accumulates in the body and provokes seizures upon repeated use [131].

Appendix A3.4. Recommended dosing regimen of low molecular weight heparins for the prevention of high-risk VTE in conservative treatment and orthopedic surgery in adult patients with high VTE risk

It should be noted that spinal or epidural anesthesia is possible only 12 hours after the administration of a dose of low molecular weight heparins and no earlier than 4–6 hours after the administration of unfractionated heparin (provided that aPTT or ACT values are within the normal range) [132, 133].

It should be noted that spinal or epidural anesthesia is possible only 12 hours after the administration of a dose of low molecular weight heparins of group B01AB and no earlier than 4–6 hours after the administration of unfractionated heparin of group B01AB (provided that aPTT or ACT values are within the normal range) [105].

Appendix B. Physician Action Algorithms

Appendix B1. Physician Action Algorithms for Suspected Distal Leg Bone Fracture

Appendix B2. Assessment of Cardiovascular Risk of Surgery

Notes and abbreviations:

CVRF – cardiovascular risk factors (arterial hypertension, smoking, dyslipidemia (elevated total cholesterol >4.9 mmol/L and/or LDL cholesterol >3 mmol/L and/or HDL cholesterol <1.0 mmol/L in men, <1.2 mmol/L in women, and/or triglycerides >1.7 mmol/L), diabetes mellitus, family history of premature cardiovascular disease (<55 years for men and <65 years for women);

CVD – cardiovascular disease (coronary artery disease, cerebrovascular disease, peripheral artery disease, chronic heart failure, pulmonary hypertension, valvular heart disease, cardiomyopathies);

rRCRI - reconstructed RCRI index (See Appendix G2);

FS – functional status (the patient's ability to climb 2 flights of stairs independently without stopping before the injury).

*- regional vascular center or specialized cardiological department.

Appendix C. Patient Information

Distal leg bone fractures are severe injuries requiring specialized treatment in a traumatology department. Conservative treatment of such injuries is only possible for non-displaced or minimally displaced fractures. This type of treatment involves prolonged immobilization with a plaster cast or its equivalents. Its main disadvantage is the increased duration of treatment and the need for prolonged rehabilitation, as immobilization results in knee and ankle contractures. Surgical treatment is indicated for all displaced fractures, especially intra-articular ones. Various plate configurations, intramedullary nails, and external fixation devices in various configurations can be used to treat distal tibial fractures. Treatment can be single-stage (for isolated closed fractures and satisfactory soft tissue condition) and two-stage, where the fracture is first temporarily fixed with an external fixator followed by conversion to internal fixation (in multiple and polytrauma, severe open fractures, and significant soft tissue trauma). In intra-articular fractures, the goal must be the complete restoration of the articular surface anatomy. To this end, it is usually necessary to open the fracture site and reduce the fragments under direct visual control. For extra-articular fractures, complete restoration of the anatomy of the injured bone is not required; it is sufficient to restore the axis and length of the limb and eliminate rotational displacement. In most cases, minimally invasive osteosynthesis techniques are used for this purpose, which do not involve opening the extra-articular fracture site. In all cases, the goal must be stable osteosynthesis that does not require additional external immobilization after surgery. This makes it possible to begin early rehabilitation treatment. When treating distal leg bone fractures, it is important to know that special attention should be paid to the condition of the soft tissues, as complications associated with impaired blood circulation in the fracture zone can lead to skin necrosis, infection, and significantly worsen the prognosis of treatment for patients with such fractures.

Rehabilitation treatment should begin immediately after surgery. It consists of passive and active movements in the joints of the lower extremity, physiotherapeutic procedures, and exercises aimed at normalizing the trophism of injured soft tissues and bone. The timing of weight-bearing on the limb may vary depending on the nature of the fracture and the method of fixation. As a rule, after intramedullary osteosynthesis of extra-articular fractures, partial weight-bearing on the limb is permitted in the first days after surgery. After osteosynthesis of similar fractures with plates, weight-bearing is permitted no earlier than 6–8 weeks postoperatively. If the fracture was intra-articular, weight-bearing is delayed further and is permitted no earlier than 3 months from the time of surgery.

Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools

Appendix G1. Caprini Scale for Individual Assessment of Risk for Venous Thromboembolic Complications (Caprini J.)

Russian title: Caprini Scale for Individual Assessment of Risk for Venous Thromboembolic Complications

Original title: Caprini Score for Venous Thromboembolism

Source: Lobastov K.V., Barinov V.E., Schastlivtsev I.V., Laberko L.A. Caprini scale as a tool for individual risk stratification of postoperative venous thromboembolism in the high-risk group. Pirogov Russian Journal of Surgery. 2014; (12):16-23.

Type: scale

Purpose: assessment of venous thromboembolism risk

Content (template):

1 point

Age 41–60 years

Lower extremity edema

Varicose veins

Body mass index over 25 kg/m2

Minor surgery

Sepsis (within 1 month)

Serious pulmonary disease (including pneumonia within 1 month)

Oral contraceptive use, hormone replacement therapy

Pregnancy and postpartum period (up to 1 month)

History of unexplained stillbirths, spontaneous abortions (≥3),

Premature birth with preeclampsia or intrauterine growth restriction

Acute myocardial infarction

Chronic heart failure (within 1 month)

Bed rest in a non-surgical patient

History of inflammatory bowel disease

Major surgery within the past 1 month

Chronic obstructive pulmonary disease

2 points

Age 61–74 years

Arthroscopic surgery

Malignant neoplasm105

Laparoscopic surgery (duration > 45 min)

Bed rest > 72 h

Limb immobilization (within 1 month)

Central venous catheterization

Major surgery (duration > 45 min)

3 points

Age > 75 years

Personal history of VTE

Family history of VTE

Factor V Leiden mutation

Prothrombin G20210A mutation

Hyperhomocysteinemia

Heparin-induced thrombocytopenia

Elevated anticardiolipin antibodies

Lupus anticoagulant

5 points

Stroke (< 1 month)

Multiple trauma (< 1 month)

Major joint arthroplasty

Femur and lower leg fractures (< 1 month)

Spinal cord injury/paralysis (< 1 month)

Key: Depending on the score obtained from history taking and patient examination, the patient is assigned to a specific risk group:

• low risk: 0–1 points;

• moderate risk: 2 points;

• high risk: 3–4 points;

• very high risk: 5 points or more

Appendix G2. Reconstructed Cardiac Risk Index rRCRI

Russian title: Reconstructed cardiac risk index for noncardiac surgical procedures

Original title: Reconstructed Revised Cardiac Risk Index (rRCRI)

Source: Davis C., Tait G., Carroll J. et al. The Revised Cardiac Risk Index in the new millennium: a single-centre prospective cohort re-evaluation of the original variables in 9,519 consecutive elective surgical patients. Can. J. Anaesth. 2013; 60(9): 855-863.

Type: scale

Purpose: prediction of the risk of perioperative cardiac complications in noncardiac surgery: myocardial infarction, pulmonary edema, ventricular fibrillation or cardiac arrest, complete AV block.

Content:

1. High-risk surgery (intrathoracic, intra-abdominal, or suprainguinal vascular surgery) – 1 point.

2. Ischemic heart disease (myocardial infarction, positive stress test, angina pectoris, nitroglycerin use, pathological Q wave on ECG) – 1 point.

3. Heart failure (history of heart failure, pulmonary edema, paroxysmal nocturnal dyspnea, bilateral pulmonary rales, gallop rhythm, pulmonary congestion on chest X-ray) – 1 point.

4. TIA/Stroke – 1 point.

5. Creatinine clearance <30 ml/min - 1 point

Scoring:

• total score of 0 – low risk of cardiovascular complications;

• a total score of 1 – moderate risk of cardiovascular complications;

• a total score of 2 or more – high risk of cardiovascular complications.

Notes:

The RCRI index was developed in 1977 [37] to predict the risk of perioperative cardiac complications in noncardiac surgery. It was validated in the Lee study [60], and in 2013 [25] it was revised and re-validated based on clinical risk factors (instead of the criterion "creatinine level >176.8 µmol/L", the scale uses the criterion "creatinine clearance <30 mL/min"; the clinical criterion "insulin-requiring diabetes mellitus" was removed), which is why it is called the revised cardiac risk index. It includes 5 parameters, each assigned 1 point. This specific version of the index is recommended by the Russian Society of Cardiology [114].