Tibial Shaft Fractures: Clinical Guidelines

List of Abbreviations

EAF – external fixation apparatus

AO – Association for Osteosynthesis

Tibia - tibia

VTE – venous thromboembolism

DT – diaphyseal tibia

ДТП - motor vehicle accident

Knee joint - knee joint

CT — computed tomography

HDL — high-density lipoproteins

LDL – low-density lipoproteins

Exercise therapy - physical therapy

Russian Ministry of Health - Ministry of Health of the Russian Federation

MRI - magnetic resonance imaging

LMWH - low-molecular-weight heparins from group B01AB Heparin group

NSAIDs – nonsteroidal anti-inflammatory drugs from group M01A Nonsteroidal anti-inflammatory and antirheumatic products

PPLE - proximal part of the lower leg bones

TPF - tibial plateau fracture

FHNFB - fracture of the head of the fibula

ATS - antitetanus serum

TIG - tetanus immunoglobulin

PCD – primary 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

SAP – surgical antibiotic prophylaxis

ECG - electrocardiography

LCP – locking compression plate

MIPO - minimally invasive plate osteosynthesis

ORIF - open reduction internal fixation

TEN - titanium elastic nail - titanium elastic nail

Terms and Definitions

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

Allograft - a fragment of another person's (donor's) bone tissue, typically cadaveric, that has undergone a preservation procedure.

External fixation apparatus (EFA) – an orthopaedic device comprising an implant (a transosseous or extracortical element protruding through the skin, reaching or embedded in the bone) and an external (non-implantable) support connecting bone fragments via transosseous elements in the treatment of fractures, pseudarthrosis, or gradual lengthening (correction of deformity) of a segment.

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

Internal fixator – an orthopaedic implant surgically implanted beneath the patient's skin to connect bone fragments in the treatment of fractures, deformities, or pseudarthrosis.

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

Fracture consolidation - the mutual joining of fragments by living bone tissue due to the successful completion of the reparative regeneration process.

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

Bone fragment – a portion of bone separated as a result of injury, surgical intervention, or a destructive process.

Migration of fixation elements - the loss of the optimal position of fixation elements due to bone resorption around them, occurring when permissible cyclic loads, their number, or installation technology into the bone are exceeded (within the context of this topic).

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

Impaired bone healing – alterations in reparative bone regeneration leading to decreased rate, cessation, or formation of a callus insufficient to perform mechanical function.

Post-traumatic deformity - fracture consolidation with a violation of spatial, including axial and rotational, relationships between fragments.

Fixation stability – the 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

Tibial shaft fractures are a non-classification concept combining fractures of the upper, middle, and third thirds of the tibial shaft. These fractures represent a disruption of the integrity of the tibia in the diaphyseal region, excluding its proximal and distal segments bounded by squares whose sides are the widest parts of the proximal and distal metaphyses, resulting from a traumatic impact. These injuries are extra-articular in nature. According to the number of fragments, tibial shaft fractures are divided into simple and comminuted. In most cases, tibial fractures are combined with fibular fractures; however, the nature of the fibular fracture is not decisive in choosing treatment tactics, but with certain types of fractures of both bones of the leg, osteosynthesis of the fibula significantly increases the stability of the synthesized tibia, Raymond G. Kim et al. (2022). [35]

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

Tibial shaft fractures occur as a result of a high-force external traumatic agent. According to the mechanism of injury, direct and indirect impact are distinguished. In the direct mechanism of injury, the force is applied directly to the fracture site. The indirect mechanism of injury is characterized by the fact that the traumatic force is applied far from the fracture site. According to the energy of injury, high-energy and low-energy fractures are distinguished. The former are usually the result of direct trauma and are accompanied by significant damage to the surrounding soft tissues. Low-energy fractures have an indirect mechanism of injury and occur during rotation of the leg with a fixed foot or, conversely, rotation of the foot with a fixed leg [6, 93]. High-energy tibial shaft injuries occur during road traffic accidents, falls from a height, and sports activities [6, 93]. An anatomical and functional feature of the leg is that the two bones, the tibia and fibula, forming the skeleton of the segment, have completely different functions. The weight-bearing capacity of the leg is determined by the tibia (TIB), while the fibula (FIB) is actually a vestige and only participates in the formation of the ankle joint [78].

1.3 Epidemiology of the Disease or Condition

Diaphyseal fractures of the leg bones are the most common skeletal injury, occurring with a frequency of 16.9–18.7 cases per 100,000 population [11, 37, 71, 78]. These fractures account for 8.1 to 31.5% of all skeletal fractures or 64.3%–70% of lower limb bone fractures [9, 83]. Temporary disability of patients with leg bone fractures varies widely: from 5–6 weeks to 5–7 months, and in complex fractures reaches 10–12 months [29, 77]. In the structure of disability caused by the consequences of fractures of various localizations, they occupy a leading place and account for 5.5 to 39.8% [84]. In tibial shaft fractures, compartment syndrome develops with a frequency of up to 9%, especially in cases of a high-energy injury mechanism [63].

1.4 Features of Coding the Disease or Condition

S82.2 - fracture of shaft (diaphysis) of tibia;

S82.20 - closed fracture of shaft (diaphysis) of tibia;

S82.21 - open fracture of shaft (diaphysis) of tibia.

1.5 Classification of the disease or condition

Diaphyseal fractures are divided into simple, wedge-shaped, and multi-fragmentary (complex).

Simple fracture is a single-line fracture in which the contact area between fragments after reduction exceeds 90%. Simple fractures are subdivided into spiral, oblique, and transverse or close to them.

Wedge fracture – a fracture containing 3 or more fragments. Following reduction, the main fragments remain in contact with each other. The wedge may be intact or fragmented.

Multi-fragmentary (complex) fracture also contains 3 or more fragments, however, unlike a wedge-shaped fracture, after its reduction there will be no contact between the main fragments. The intermediate fragment of a complex fracture can be spiral, segmental, or irregular.

To accurately determine the anatomical location of a fracture, its center must be identified. For a simple fracture, the center is the midpoint of the oblique or spiral fracture line; for fractures with a wedge, it is the widest part of the wedge or the midpoint of the fragmented wedge after reduction; for complex fractures, the center is determined after reduction with restoration of bone length as the midpoint between the proximal and distal borders of the fracture.

Coding of the diagnosis begins with determining the anatomical location of the fracture: the bone and segment. According to the AO classification, the tibia has the number 4. The tibial shaft is coded as 42. Then the morphological characteristic of the fracture is determined. It consists in determining the type, group, and subgroup of the fracture. All fractures are subdivided into 3 types: A, B, and C.

According to the universal AO fracture classification, tibial shaft fractures correspond to code 42-. Fractures of this localization are divided into the following groups:

42-A - simple fracture:

32-A1 - simple fracture, spiral;

32-A2 - simple fracture, oblique (> or = 30⁰);

32-A3 - simple fracture, transverse (<30⁰);

42-B - wedge fracture:

32-B2 - wedge fracture, bending wedge, intact;

32-B3 - wedge fracture, fragmented wedge;

42-C – multi-fragmentary (complex) fracture;

32-C2 - multi-fragmentary fracture with an intact segmental fragment;

32-C3 - multi-fragmentary fracture, irregular.

Fibula fractures are classified separately:

4F1 - fracture of the proximal segment of the fibula;

4F2 - fracture of the fibular shaft;

4F1- fracture of the distal segment of the fibula [44].

For open tibial shaft fractures , the classification of R.B. Gustilo, J.T. Anderson (1976) [24] modified by R.B. Gustilo, R.M. Mendoza, and D.N. Williams (1984) [25] is used:

Type I - open fracture, wound is slightly contaminated, wound size is less than 1 cm;

Type II - open fracture, wound is more than 1 cm and less than 10 cm in length without severe soft tissue damage, flaps, or skin detachment;

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

Type IIIB - open fracture, with an extensive soft tissue defect, periosteal stripping, and a multi-fragmentary fracture pattern, often with severe microbial wound contamination;

Type IIIC - open fracture accompanied by damage to major vessels requiring reconstructive interventions, regardless of the degree of soft tissue damage.

1.6 Clinical presentation of the disease or condition

The clinical picture of tibial shaft fractures is characterized by severe pain syndrome at the fracture site, tenderness upon palpation and axial loading, and pathological mobility in the fracture zone. If displacement of fragments is present, deformation is determined at the fracture site, and limb shortening is possible, which can reach 5–7 cm [86, 93, 94].

If a tibial shaft fracture is suspected, all patients must be evacuated to a medical organization to verify the diagnosis.

Complaints: pain at the fracture site, impaired limb weight-bearing capacity, leg deformity, pathological mobility, pain in the wound area (in open fractures).

Anamnesis: history of trauma, the patient describes a characteristic mechanism of injury. The mechanism of injury may be indirect – rotation of the leg with a fixed foot or, conversely, rotation of the foot with a fixed leg, falling from a height onto an extended lower limb. In the case of a road traffic accident or criminal violent acts, a direct injury mechanism may be observed – a direct impact of the traumatic agent on the leg.

Objectively: edema of the leg, knee and ankle joint areas, restriction of active and passive movements due to severe pain syndrome, visually determined leg deformity, tenderness upon palpation and axial loading in the injury zone, crepitation of bone fragments, pathological mobility of the leg at some level.

2. Diagnostics, medical indications and contraindications for diagnostic methods

Criteria for establishing the diagnosis/condition:

• anamnestic data: indication of a characteristic lower limb injury mechanism (fall, blow to the segment, road traffic accident, etc.);

• physical examination data: impaired function of the damaged segment, local edema and tenderness of the injury area (tenderness increases with axial loading), presence of pathological mobility and/or fragment crepitation;

• instrumental examination data: radiographic signs of fracture based on the results of radiography of the tibia and fibula in 2 projections. Additional lower limb CT may be performed as prescribed by the on-duty or attending trauma-orthopedic physician to clarify the nature of the fracture and determine the degree of fragment displacement.

2.1 Complaints and Anamnesis

In most cases, patients present with the complaints described in section 1.6 "Clinical Presentation".

2.2 Physical Examination

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

• Evaluation of the following parameters (Initial trauma-orthopedic physician's appointment (examination, consultation)) for diagnostic purposes is recommended to be performed for all patients with suspected tibial shaft fracture no later than 1 hour after admission to the hospital with mandatory indication of the results in the medical history [86, 93, 94, 101]:

- assessment of somatic status;

- visual and palpation assessment of local status.;

- measurement of blood pressure on peripheral arteries;

- measurement of body temperature;

- assessment of the risk of venous thromboembolic complications (Appendix G1) [80, 108].

Leveled position 5Level of recommendation evidence C (level of data reliability - 5).

• All patients with suspected tibial shaft fracture are recommended to undergo an assessment of peripheral innervation and blood supply to rule out neurovascular bundle injury at the fracture level [86, 93, 94, 101].

GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).

• All patients with suspected tibial shaft fracture are recommended to undergo an assessment of soft tissue status and edema severity to rule out hematomas, hemarthrosis, developing compartment syndrome, and open fractures [47, 49, 63, 101].

GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).

• When deciding on surgical treatment for a tibial shaft fracture in adult patients, it is recommended to take a medical history and perform a physical examination to identify risk factors and cardiovascular diseases [4, 26].

GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).

Comment: Cardiovascular disease risk factors include: 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) [26]. Established cardiovascular diseases are defined as: coronary artery disease, cerebrovascular disease, peripheral artery disease, chronic heart failure, pulmonary hypertension, valvular heart disease, and cardiomyopathies [4, 17].

• All adult patients scheduled for elective surgical treatment of a tibial shaft fracture are recommended an assessment of perioperative cardiovascular risk based on the type of planned surgery, regardless of any concomitant pathology [22, 26].

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

Comments: When surgical treatment is performed for emergency (<6 hours) and urgent (6–24 hours) indications, preoperative risk assessment is not performed.

Minor orthopedic procedures are associated with a low risk of cardiovascular complications (30-day risk of myocardial infarction or cardiovascular death after surgery is less than 1%). Major orthopedic procedures are associated with an intermediate (moderate) risk of cardiovascular complications (30-day risk of myocardial infarction or cardiovascular death after surgery is 1-5%) [89].

• To assess the risk of perioperative cardiovascular complications in adult patients, it is recommended to use a special algorithm (Appendix B2) [19, 22].

GCR CLEL 3Grade of Recommendation C (Level of Evidence — 3).

• Elective surgical treatment for a tibial shaft fracture is recommended without additional workup in patients assessed as having a low risk of cardiovascular complications. In patients with an intermediate or high perioperative risk of cardiovascular complications, an assessment of the patient's functional status is recommended [64, 89].

GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).

2.3 Laboratory Diagnostics

• All patients diagnosed with a tibial shaft fracture are recommended the following laboratory tests for diagnostic purposes:

- complete blood count;

- urinalysis;

- general clinical blood biochemistry analysis;

- determination of main blood groups by the ABO system and determination of the D antigen of the Rhesus system (Rh factor);

- screening for hepatitis B virus surface antigen (HBsAg) in the blood:

- screening for hepatitis C virus antibodies (anti-HCV IgG) in the blood;

- screening for human immunodeficiency virus HIV-1/2 antibodies (IgM, IgG) and p24 antigen in the blood;

- screening for antibodies to Treponema pallidum in the blood,

- coagulogram (exploratory hemostasis test);

- determination of the international normalized ratio (INR) [3, 31, 56, 76, 86].

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

• When deciding on surgical treatment for a tibial shaft fracture in adult patients, it is recommended to test blood levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in cases of intermediate or high cardiovascular risk and low functional status (see Appendix B2) [26, 57, 76, 89].

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

2.4 Instrumental Diagnostics

• All patients with suspected tibial shaft fracture are recommended to undergo radiography of the tibia and fibula including adjacent joints in two projections for diagnostic purposes [6, 49, 93].

GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).

Comments: Performing radiography of the leg including two joints is necessary to diagnose a tibial shaft fracture, determine the fracture pattern and degree of displacement, and rule out injuries at other skeletal levels. In cases of significant limb shortening due to the fracture, radiographs may be taken under manual or skeletal traction along the axis of the injured limb to better visualize the fracture zone [6, 46, 66]. After confirming the tibial shaft fracture by diagnostic imaging, the patient must be hospitalized.

If a patient refuses inpatient treatment, the reason for refusal must be documented in the inpatient medical record with the signature of the patient or their legal guardians (in cases of legally established incapacity).

• All patients with a tibial shaft fracture are recommended to undergo multislice computed tomography (MSCT) of the distal tibia (lower extremity CT) or knee joint (joint CT) if extension of the fracture into the ankle or knee joint is suspected, in order to clarify the diagnosis [6, 46, 48].

GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).

Comments: MSCT provides the orthopedic trauma surgeon with additional information on the fracture pattern, degree of fragment displacement, and severity of articular surface involvement, thereby significantly improving preoperative planning. [6, 18, 46, 48].

• Echocardiography may be considered prior to planned surgical treatment of a tibial shaft fracture in adult 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 [7, 66, 89].

Leveled position 5Level of recommendation evidence C (level of data reliability - 5).

2.5 Other Procedures

• When treating patients with a tibial shaft fracture the attending physician is recommended to consider the following indications for consultations with relevant specialists 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;

- general surgeon consultation: in case of suspected or objectively diagnosed concomitant abdominal trauma;

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

- physician consultation: in the presence of comorbid medical conditions (according to medical history) [90, 93, 94, 101].

GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).

• If acute or unstable clinical conditions are identified, it is recommended to postpone elective surgical treatment of the tibial shaft fracture until cardiac status improves and the patient's condition stabilizes; transfer to a regional vascular center or specialized cardiology department is indicated [89].

GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).

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

3.1 Conservative Treatment

Patients with tibial shaft 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 relief;

• correction of fluid and electrolyte imbalances[6, 85, 86, 90, 101, 108].

GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).

• Patients with a tibial shaft fracture are recommended conservative treatment as definitive therapy to achieve fracture union in the following cases:

- low-energy fractures,

- nondisplaced or minimally displaced fractures,

- patient refusal of surgical treatment,

- tibial shaft fracture in a patient with a spinal cord injury,

-

- tibial shaft fracture in a patient with a comorbid condition that is an absolute contraindication to surgery,

- in case of patient's voluntary refusal of surgical treatment [6, 86, 94, 101].

LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).

Comments: Primary immobilization with a plaster cast (application of a plaster cast for bone fractures) is possible in cases of fractures with minor fragment displacement and no tendency toward axial malalignment and segment shortening (42A3 fractures). In this case, immediately upon admission of the patient to the hospital, a split circular plaster cast or a plaster splint is applied, which can be converted into a circular cast after the edema subsides.

In cases of low-energy 42A1 and 42A2 fractures, conservative treatment consists of two stages. The first stage involves treatment with calcaneal skeletal traction. The traction force counteracts the muscle pull force, which promotes gradual fracture reduction. The position of the fragments must be controlled by staged radiographs during skeletal traction, which are performed 3 – 5 days after applying the skeletal traction system and 3 – 4 weeks before conversion to a plaster cast. If a satisfactory position of the fragments is achieved on skeletal traction, the next stage of conservative treatment is the application of a plaster cast. The criterion for the possibility of removing skeletal traction is the absence of pathological mobility in the fracture zone, which indicates the formation of a primary bone callus and minimizes the risks of secondary fragment displacement during the application of the plaster cast. The plaster cast is applied while skeletal traction is maintained; the latter is removed after the plaster cast has hardened.

The total duration of immobilization is 8 – 16 weeks.

Failure to achieve fragment reduction on skeletal traction or in a plaster cast, as well as secondary fragment displacement during conservative treatment stages, are indications for surgical treatment [6, 86, 93].

Comments: when immobilizing with a plaster splint or circular cast for up to 6 weeks, axial load on the injured extremity must be avoided. Primary immobilization with a skeletal traction system may be replaced by plaster immobilization if necessary. Regardless of the immobilization method, the following complications may develop: knee joint contracture, pressure ulcers, pulmonary congestion, deep vein thrombosis of the lower extremities, muscle atrophy [85, 86].

3.2 Surgical Treatment

Indications for surgical treatment of tibial shaft fractures:

• fractures with fragment displacement,

• open fractures,

• fractures accompanied by major vascular and nerve injuries,

• fractures as part of polytrauma,

• compartment syndrome,

• social indications.

Timing of surgical treatment. For patients with low-energy tibial shaft fractures, as well as high-energy fractures not accompanied by marked soft tissue swelling, definitive internal fixation can be performed immediately after admission to a specialized hospital. If it is not possible to perform surgery within the first 24 hours after injury, an external fixation device, skeletal traction system, or plaster splint should be temporarily used until posttraumatic edema subsides and soft tissue trophism normalizes. Definitive internal fixation in such cases should be performed no earlier than 4 – 5 days, and often 7 – 10 days after the injury, depending on the regression dynamics of posttraumatic edema.

When using a circular external fixation device (Ilizarov apparatus) as the method of definitive osteosynthesis, time restrictions for surgery may not apply.

• Patients with tibial shaft fractures are recommended to undergo intramedullary osteosynthesis for tibial shaft fractures in order to create conditions for fracture union [6, 27, 33, 40, 85, 93, 94].

GCR ALEL 3Grade of Recommendation A (Level of Evidence - 3).

Comments: When performing intramedullary osteosynthesis of the tibial shaft, 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***. For pediatric patients, TEN (Titanium Elastic Nail), which is a pediatric intramedullary fixator for long tubular bones, is applicable (Intramedullary rods and nails: flexible intramedullary nail).

Intramedullary osteosynthesis can be performed for all tibial shaft fractures. When using an infrapatellar approach to access the intramedullary canal, the lower extremity is fixed on a special attachment to the orthopedic table in a knee-flexed position. Alternatively, preliminary fixation with a distractor or external fixator rod system can be used, which also allows flexion of the lower extremity at the knee joint. In this case, the rods are inserted so that they do not conflict with the intramedullary nail. When using a suprapatellar approach, the surgery is performed on a general surgical table in a knee-extended position. Fragment reduction is performed closed. For this purpose, additional reduction tools are used if necessary: percutaneous reduction forceps, poller screws (orthopedic bone screw, non-absorbable, sterile***, orthopedic bone screw, non-absorbable, non-sterile***) and wires (orthopedic bone wire***), Schanz screws as joysticks. For interlocking, a minimum of two screws proximally and distally must be used. For osteosynthesis of proximal and distal fractures, the introduction of additional locking screws is recommended to improve fixation quality. Proximal locking is performed using targeting devices. Distal locking is performed using the "free hand" method under direct fluoroscopic control or using targeting devices. When using targeting devices, fluoroscopic control of the locking screw insertion quality is mandatory.

Reaming of the medullary canal allows for an increase in its diameter and the use of a larger-diameter intramedullary nail, which increases fixation stability by increasing the bone-nail contact area. In addition, reaming has an osteoinductive and osteogenic effect due to bone fragments entering the fracture zone. Indications for reaming include a narrow or tortuous medullary canal and hypertrophic nonunions. Furthermore, reaming can be used in other cases to increase fixation stability. When treating a pediatric patient using a TEN, the insertion of pediatric nails into the tibia is usually performed antegrudely from the proximal metaphyseal zone, with intraoperative marking of the bone growth plate and creation of the medullary canal entry point with a bone awl 7 millimeters or more distal to the growth plate. The selection of nail size is carried out during preoperative planning based on digital radiography (MSCT) data by determining the narrowest distance of the medullary canal and selecting two nails by diameter. The use of a C-arm (image intensifier) makes it possible to achieve closed reduction and stable osteosynthesis with this type of fixator in pediatric patients in a minimally invasive manner.

• There are no absolute indications for intramedullary osteosynthesis of the tibial shaft. It is recommended to take into account the following contraindications for intramedullary osteosynthesis in order to create conditions for fracture union in patients with tibial shaft fractures:

- contaminated wound in the knee joint area,

- skin and soft tissue defects of the lower leg,

- soft tissue injuries or burns at the site of intended nail insertion and interlocking,

- presence of an implant or endoprosthesis in the proximal tibia [6].

GCR BLEL 3Recommendation Grade B (Level of Evidence — 3).

Comments: In intramedullary osteosynthesis of tibial shaft fractures, both reamed and unreamed techniques of the medullary canal can be used. The rate of bone healing is lower with unreamed osteosynthesis. In addition, these patients more frequently require repeat surgeries [15, 74]. The technical performance of TEN implantation in pediatric patients does not involve enlarging the medullary canal lumen by reaming.

• Patients with tibial shaft fractures are recommended to undergo plate osteosynthesis for tibial shaft fractures to create conditions for fracture healing, taking into account the following relative indications:

- high and low tibial shaft fractures extending into the knee or ankle joint;

- narrow or deformed medullary canal;

- associated spinal or pelvic fractures (risk of additional trauma when using traction on an orthopedic table during intramedullary fixation);

- associated vascular injuries requiring surgical repair;

- periprosthetic or peri-implant fractures;

- associated severe chest injuries with pulmonary contusion, increasing the risk of intramedullary osteosynthesis [6].

LoR CGoE 4Level of Recommendation C (Grade of Evidence - 4).

Comments: The following implants are used when performing plate osteosynthesis of the tibial shaft: non-absorbable sterile bone-fixation plate with screws***, non-absorbable non-sterile bone-fixation plate with screws***, non-absorbable sterile orthopedic bone screw***, non-absorbable non-sterile orthopedic bone screw***.

Plate osteosynthesis can be performed using the traditional open technique or minimally invasively. Open direct fracture reduction is performed for simple shaft fractures. In such cases, anatomical reduction and plate osteosynthesis must be performed, ensuring interfragmentary compression using a lag screw or inserting screws into the eccentric holes of the plate. It must be taken into account that open direct reduction significantly traumatizes soft tissues and is not an optimal technique from a biological perspective. This is confirmed by the high rate of infectious complications following such surgeries.

Minimally invasive plate osteosynthesis is performed without opening the fracture site. The plate is inserted through a small skin and soft tissue incision above or below the fracture site and advanced epiperiosteally, after which fracture fixation with screws is performed through the existing incision and an additional incision on the opposite side of the plate insertion. In such cases, fragment reduction is performed closed, and the plate acts as a bridge fixator. When using this technique, long angle-stable plates and locking screws must be used. In addition to locking screws, conventional screws can also be used to improve the reduction of bone fragments.

Disadvantages of the minimally invasive plate osteosynthesis method include the impossibility of early full axial loading on the operated limb [6, 34, 69].

External fixation for tibial shaft fractures is primarily used as a temporary osteosynthesis method.

As a definitive osteosynthesis method, external fixation for tibial shaft fractures is rarely used today in the presence of soft tissue and bone defects or infection due to specific complications and limitations (pin-track infections, rehabilitation difficulties, patient inconvenience). As a rule, external fixation is used as a provisional osteosynthesis method in cases of open fractures and polytrauma. For this purpose, single- and multi-plane pin fixators, as well as circular Ilizarov apparatuses, can be used. After the normalization of trophism, reduction of soft tissue edema, and stabilization of the patient's general condition, conversion to internal fixation is performed. The rate of infectious complications increases when definitive fixation is performed later than 14 days from the moment of external fixator application, especially in cases of multiple and polytrauma [51]. Circular Ilizarov apparatuses can also be used as a definitive fixation method. When using the Ilizarov apparatus as a definitive fixation method, its disadvantages must be taken into account: pin-track infection, patient discomfort, and the need for periodic evaluations.

• Patients with tibial shaft fractures are recommended to undergo extrafocal osteosynthesis using external fixation devices for temporary or definitive fragment fixation [6, 51, 88, 93, 94].

GCR BLEL 3Recommendation Grade B (Level of Evidence — 3).

Comments: In the unstable patient, damage control tactics and primary temporary external fixation are indicated. Severe concomitant chest and brain injuries may serve as an indication for damage control tactics with primary temporary immobilization using an external fixation device; however, primary intramedullary fixation of long bone fractures in such cases also provides improved ventilation and normalization of intracranial pressure [50].

Temporary external fixation reduces blood loss and operative time compared to primary internal osteosynthesis in patients with lower extremity long bone fractures as part of polytrauma, and also decreases interleukin-6 levels. Definitive internal fixation can be performed within 2 weeks after the injury [51, 53, 58]. In cases of isolated tibial shaft fractures with technical feasibility and satisfactory soft tissue condition, primary internal osteosynthesis is indicated. If primary internal osteosynthesis cannot be performed, skeletal traction or external fixation immobilization is carried out, after which the patient is transferred to the trauma department.

• The use of an external fixation device (EFD) as a definitive treatment method in patients with tibial shaft fractures to create conditions for fracture healing is recommended taking into account the following indications:

- extensive skin and soft tissue defects that cannot be resolved in the early post-traumatic period;

- surgical site infection;

- extensive bone defects requiring reconstruction using bone lengthening technology [40].

GCR BLEL 3Recommendation Grade B (Level of Evidence — 3).

Comments: Compartment syndrome is the most serious complication of tibial shaft fractures. Its pathogenesis consists in the impairment of muscle blood circulation within closed fascial compartments with the development of ischemia against the background of increasing post-traumatic tissue edema.

Clinical signs of compartment syndrome:

• pain out of proportion to the injury,

• tense edema of the lower leg,

• severe pain on passive muscle stretching (this symptom is usually checked by passive plantarflexion of the first toe).

Upon manifestation of compartment syndrome, the pressure in the fascial compartments rises to 30 mm Hg or more, but clinical data must be relied upon for diagnosis and decision-making, as pressure measurement data can be erroneous. In addition, in hypotensive patients, compartment syndrome may develop at lower fascial compartment pressure values due to a low gradient between the diastolic blood pressure and the fascial compartment pressure.

Upon diagnosing compartment syndrome, emergency fasciotomy with opening of all four fascial compartments of the lower leg is indicated. The surgery is completed by stabilizing the fracture using one of the osteosynthesis methods described above [1, 6, 52, 59, 60].

Open fractures. In the treatment of G1 – G2 open fractures, the patient management tactics do not differ from those for closed fractures. In such injuries, primary internal osteosynthesis can be performed immediately upon admission of the patient to the hospital after thorough initial surgical debridement of the wound. If primary internal osteosynthesis cannot be performed upon admission, it is performed after wound healing.

 In the treatment of Gustilo-Anderson type 3 open fractures, following initial surgical debridement, osteosynthesis with an external fixation device must be performed. In the presence of skin defects, efforts should be made to cover them as early as possible using local tissues, non-free muscle flaps, split-thickness skin grafts, or vascularized tissue grafts. Conversion to internal fixation in such cases is feasible after skin coverage has been achieved [6].

3.3 Other Treatment

• For adequate pain relief, patients with tibial shaft fractures are advised to receive multimodal analgesia for adults and children, taking into account age-related restrictions, which may include NSAIDs from the M01A (Anti-inflammatory and antirheumatic products, non-steroids) group, paracetamol**, gabapentinoids, and immediate-release opioids, or monomodal analgesia if multimodal therapy cannot be prescribed [16, 70, 72].

GPP ALE 2Grade of Recommendations 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 administration of several analgesics (opioid and non-opioid) from the N02 (Analgesics) group with different mechanisms of action, combined with non-pharmacological interventions targeting the peripheral and/or central nervous system [30]. This combination provides more effective pain relief by potentiating the effects of various medications, which in most cases leads to a reduced frequency of prescriptions and/or 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 injection or peripheral nerve catheter placement), local injections, and opioids [72].

In modern scientific literature, authors emphasize 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 administered preoperatively (60 minutes before the incision) can be used, as it provides significant pain reduction [70].

It must be kept in mind that parenteral administration of most NSAIDs (ketorolac**, diclofenac**) is limited to a maximum of two days, which requires timely switching the patient to oral administration, changing the drug, or approving further use with a medical committee. The specific choice of local anesthesia technique and medications is made by the attending physician individually, in accordance with the patient's characteristics, local protocols, and the medical organization's equipment.

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 medicinal products for analgesia are provided in Appendices A3.1–A3.3.

• In the surgical treatment of patients with tibial shaft fractures, it is recommended to perform surgical antibiotic prophylaxis (SAP) to prevent surgical site infections via a single preoperative administration of an antibacterial drug in order to reduce the risk of infectious complications [5, 6].

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

Comments. In accordance with international clinical guidelines on the prevention of surgical site infections [5, 92], the objective of SAP is to establish 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 procedure: SAP is not required for "clean" surgical wounds not involving the placement of orthopedic implants and metallic hardware. SAP should be administered for clean-contaminated and contaminated surgical wounds, as well as for "clean" surgical wounds involving the placement of orthopedic implants and metallic hardware. In infected ("dirty") wounds, SAP is not indicated; instead, therapeutic antibiotic therapy is administered.

• In patients with tibial shaft fractures, it is recommended to use first- and second-generation cephalosporins (cefazolin**, cefuroxime**) as first-line agents for surgical antibiotic prophylaxis in traumatology and orthopedics, with glycopeptide antibacterial drugs (vancomycin**) or lincosamides (#clindamycin**) serving as alternatives in case of beta-lactam hypersensitivity [5].

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

Comments. For patients with an uncomplicated allergic history and no significant risk factors for methicillin-resistant Staphylococcus aureus colonization, first- and second-generation cephalosporins (cefazolin**, cefuroxime**) are used for SAP, administered intravenously 30 to 60 minutes prior to skin incision. In case of hypersensitivity to beta-lactam antibacterial drugs, a combination of vancomycin** with a fluoroquinolone (cipروفлоксацин**, #levofloxacin**) administered as an intravenous infusion over at least 60 minutes starting 2 hours before the incision, or #clindamycin** should be prescribed. When significant risk factors for methicillin-resistant Staphylococcus aureus (MRS) carriage are present, the SAP regimen must include an antibiotic 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 estimated timing for intraoperative administration is two half-lives after the preoperative dose). Administering antibiotics after wound closure in the operating room is ineffective and unjustified, even in the presence of indwelling drains.

Single doses of main antibacterial drugs for SAP in adult traumatology and orthopedic procedures: cefazolin** 2 g (3 g for patients weighing ≥120 kg), cefuroxime** 1.5 g, #clindamycin** 900 mg, vancomycin** 15 mg/kg as a slow IV infusion, ciprofloxacin** 400 mg, #levofloxacin** 500 mg [5].

Single doses for children should be calculated based on actual body 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 [106, 107].

Comments. In open fractures, prophylactic antibiotic administration is effective in preventing early infection, and the drug should be administered as soon as possible after the injury. Cefazolin** is the antibiotic of choice; however, in patients with open high-energy fractures featuring displacement and segmental bone loss, major vascular injury, or heavily contaminated wounds, it is advisable to broaden the spectrum of administered antibiotics to cover Gram-negative pathogens. In such cases, adding #gentamicin** (at a dose of 6 mg/kg once daily) to cefazolin** may be considered for adult patients [28, 65].. An alternative to this combination is #ampicillin+sulbactam** (at a dose of 3.0 g every 8 hours for 3 days) [67]; the latter is particularly relevant when there is a risk of clostridial infection. According to the majority of researchers, in Gustilo-Anderson type III open fractures, antibiotics should not be continued for more than 72 hours after soft tissue wound closure [45].

• In the surgical treatment of patients with tibial shaft fractures, it is recommended to perform surgical site infection prophylaxis for a duration not exceeding 24 hours [81].

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

Comments. In accordance with current regulatory documents in the Russian Federation (SanPiN 3.3686-21) and clinical guidelines [81], to achieve an effective concentration of the antibacterial drug in tissues and blood serum at the time of skin incision, antibiotics for surgical site infection prophylaxis should be administered intravenously 30 to 60 minutes prior to skin incision, or within 2 hours before the incision when using vancomycin**. The maximum duration of systemic prophylactic antibiotic administration must not exceed 24 hours after the completion of 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 has elapsed since the preoperative dose, creating a risk of the antibiotic concentration dropping below the bactericidal level and increasing the risk of surgical site infection.

Comments: Patients with tibial shaft fractures are classified as moderate to high risk for VTE due to the nature of the fracture itself, regardless of the treatment method; therefore, along with mechanical VTE prophylaxis, this patient category generally requires pharmacological prophylaxis.

To assess the risk of VTE in a patient before surgery, it is advisable to use the Caprini risk assessment scoring system (Appendix G1). All patients with limited mobility, regardless of the determined VTE risk level, are recommended to undergo mechanical VTE prophylaxis [79].

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 VTE prophylaxis, patients with moderate or high VTE risk are recommended to receive pharmacological VTE prophylaxis, typically until the patient's normal or expected level of mobility is restored [79].

• All patients with tibial shaft fractures undergoing subsequent osteosynthesis, in the absence of active bleeding, are recommended to receive VTE prophylaxis until their normal or expected level of mobility is restored [36, 38].

LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).

Comments: Preoperative pharmacological VTE prophylaxis is performed using unfractionated heparin (UFH) from the heparin group (ATC: B01AB) or, preferably, low-molecular-weight heparins (LMWH) from the heparin group (ATC: B01AB) [Appendix A3.4]. Vitamin K antagonists monitored by INR (international normalized ratio) can also be used [79].

• Patients receiving chronic antithrombotic therapy (group B01) who present with a tibial shaft fracture are recommended to receive VTE prophylaxis based on relevant guidelines [79, 82].

GCR BLOE 3Grade of Recommendation B (Level of Evidence 3).

• Patients with tibial shaft fractures managed conservatively with limb immobilization are recommended to start VTE prophylaxis immediately after bleeding has been ruled out, in order to prevent complications [79].

GCR BLOE 3Grade of Recommendation B (Level of Evidence 3).

Comments: Recommended medications and thromboprophylaxis regimens are detailed in Appendix A3.4. VTE prophylaxis in orthopedic trauma patients is thoroughly discussed in the 2022 methodological guidelines [79] and the 2023 Russian expert guidelines [87].

VTE prophylaxis in children

There is no evidence base regarding the routine use of VTE prophylaxis in children. Routine pharmacological prophylaxis in pediatric practice is not advisable. The final decision is made by the attending physician, taking into account the extent of the injury, the nature of the planned intervention, and additional patient-specific VTE risk factors. Anticoagulants currently used predominantly in children include unfractionated heparin, low-molecular-weight heparins from the heparin group (ATC code: B01AB) (off-label in the Russian Federation – requires a medical board review), and vitamin K antagonists (ATC code: B01AA) [102]. Reliable data on the pharmacology of these drugs depending on age, as well as their efficacy and safety for the prevention and treatment of thrombosis in children, are insufficient. The available literature is heterogeneous and reflects age-related differences and various clinical settings for anticoagulant use in children. Monitoring methods and target ranges have not yet been established. However, weight-based dosing generally achieves acceptable results for most indications. Nevertheless, special attention should be paid to contraindications for certain pharmaceutical agents in children, as well as their dosages as specified in the respective product labeling. To make a decision regarding pharmacological VTE prophylaxis, a consultation with a pediatrician or hematologist experienced in managing pediatric thrombosis is recommended.

Comments. Tranexamic acid** effectively reduces blood loss and leads to a smaller drop in postoperative hemoglobin levels in adult patients undergoing surgery for tibial shaft fractures. Randomized clinical trials demonstrate the efficacy of local subfascial administration in adults of #tranexamic acid** (1.0 g in 10 mL) into the surgical wound area, comparable to intravenous administration of an equivalent dose [97, 98]. Currently, there are insufficient clinical data on the efficacy and safety of tranexamic acid in children under 1 year of age; therefore, its use in this age group is contraindicated. Experience with tranexamic acid in pediatric patients is limited. The recommended dose for children aged 1 year and older is 20 mg/kg once daily.

Comments. Systematic reviews and meta-analyses demonstrate that perioperative administration of intravenous iron preparations, particularly ferric carboxymaltose**, in orthopedic trauma patients—especially in the postoperative period—is an effective alternative to blood transfusion, as it reduces the proportion of patients receiving blood transfusions, lowers the volume of packed red blood cells transfused, and decreases the incidence of infectious complications, though it does not affect mortality rates [32, 62].

Evidence for the efficacy of intravenous iron preparations in correcting preoperative iron-deficiency anemia during elective orthopedic interventions has been obtained in the pediatric population [99, 100]. Data on the use of these drugs in the postoperative period following trauma surgeries in children are lacking.

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 involving compromised integrity of the skin and mucous membranes. Emergency tetanus prophylaxis is administered up to the 20th calendar day from the moment of injury [91]. The administration of agents for emergency tetanus immunoprophylaxis is carried out differentially, depending on the availability of documented proof of preventive vaccination or immunological monitoring data on anti-tetanus immunity titers, as well as the nature of the injuries.

Emergency tetanus immunoprophylaxis is carried out in the form of:

-  passive immunization or seroprophylaxis with human anti-tetanus immunoglobulin**, or in its absence - tetanus antitoxin**;

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

-    emergency revaccination with tetanus toxoid** (or reduced-antigen tetanus-diphtheria toxoid** - Td-toxoid) to stimulate immunity in previously vaccinated individuals [39, 91].

4. Medical Rehabilitation and Sanatorium-Resort Treatment

• Postoperative patient mobilization and restoration of the range of motion in the knee and ankle joints should be initiated as early as possible. Patient activation is recommended to begin within 24 hours after surgery [6, 54].

GLE BLOD 3Level of evidence B (reliability level of evidence - 3).

Comments: Patients with tibial shaft fractures, following stabilization via intramedullary nailing with proximal and distal locking using two screws, may be allowed to bear weight on the operated limb immediately after surgery, even in cases of comminuted shaft fractures [6]. In patients following plate osteosynthesis, axial load on the limb is not recommended for 6 to 8 weeks postoperatively [6]. In pediatric patients undergoing TEN fixation, early postoperative verticalization is permitted using auxiliary support devices (crutches) and minimal weight-bearing—foot-to-floor contact of the operated limb for 6–8 weeks until radiological confirmation of callus formation signs, with a gradual increase and restoration of weight-bearing on the operated limb.

The tasks of the early postoperative period are the prevention of general postoperative complications from the cardiovascular system, respiratory organs, gastrointestinal tract, and the prevention of trophic disorders. Prevention of local complications includes reducing soft tissue edema and creating optimal anatomical and physiological conditions for the healing of tissues traumatized during surgery.

From the first day after surgery, the patient is prescribed breathing exercises, active exercises for the joints of the unaffected limb (hip, knee, ankle), and isometric exercises for the muscles (gluteal, quadriceps, biceps femoris, calf muscles) of the operated limb. The use of a continuous passive motion (CPM) device for passive movements in the knee and ankle joints on a functional splint is possible, with a gradual increase in the flexion angle for the operated limb as prescribed by the physical therapy doctor. Sessions on the splint are conducted for 15–30 minutes, 3–5 times a day.

Gait training after surgery begins in the early postoperative period and continues into the late postoperative period. It is performed individually depending on the patient's age, physical status, and the specifics of the fracture and surgery. Most elderly patients are first taught to walk using a walker, and then, taking into account the patient's condition, using two crutches. Young, physically healthy patients are immediately taught to walk on two crutches. Gait training using assistive devices is carried out in front of a full-length mirror. Attention must be paid to restoring the normal gait stereotype in the first days after surgery.

Physical therapy methods are aimed at reducing pain and edema, relieving inflammation, and improving tissue perfusion and soft tissue metabolism in the surgical area. The use of physiotherapeutic procedures is indicated in the absence of contraindications, as prescribed by a physical therapist.

Comments: Depending on the localization and nature of the fracture, the method of reduction and fixation is determined either by a plaster cast or by preliminary skeletal traction through the calcaneus for 3–4 weeks, followed by immobilization with a plaster cast ranging from 4 weeks in pediatric patients to 14–16 weeks [14]. Following a consultation with a physical medicine and rehabilitation physician / physical therapist, a rehabilitation program is formulated prescribing dynamic exercises for the unaffected limbs, isometric exercises for muscles beneath the plaster cast, ideomotor movements for the knee and ankle joints, and self-assisted movements for the hip joint. During the period of skeletal traction, special attention is paid to breathing exercises and active movements of the unaffected limbs to prevent hypostatic complications.

Gait training without weight-bearing on the injured leg is conducted using crutches or a walker. Gradual weight-bearing on the leg, as confirmed by a follow-up radiograph, is permitted after 6 weeks.

The rehabilitation program is based on general knowledge of the mechanisms of action of various physical exercises for the prevention of complications associated with prolonged immobilization [55, 75].

Comments: After removal of the plaster cast, the physical medicine and rehabilitation physician / physical therapist draws up a rehabilitation program prescribing physical therapy and physiotherapy modalities: dynamic exercises for the unaffected limbs, assisted movements in the knee and ankle joints, basic mechanotherapy, passive mechanotherapy for the knee and ankle joints, aquatic physical exercises, positioning therapy, soft tissue stretching exercises, manual and/or apparatus lymph drainage, and manual and/or underwater massage [43, 55, 75].

Of the physiotherapeutic methods, local cryotherapy, electrotherapy, ultrasound therapy for joint diseases, and hardware lymphatic drainage are prescribed depending on clinical symptoms [20].

Two weeks after the repeated consultation with a physical and rehabilitation medicine physician / exercise therapy physician, provided there is sufficient mobility of the knee and ankle joints, active mechanotherapy for bone fractures, dynamic resistance and weight-bearing exercises, static exercises, manual joint mobilization, gym equipment training, balance therapy, and proprioceptive training with biofeedback (exercise therapy for bone fractures, biofeedback-assisted training) are prescribed.

Gait training without limb weight-bearing and with partial weight-bearing is carried out. Full weight-bearing and gait training begin at 3 months after the fracture [43, 55, 75], and in pediatric patients, starting from 2 months if radiological data confirm stabilization of the fracture site.

All publications note the necessity and importance of rehabilitation to accelerate the restoration of limb function and weight-bearing capacity; however, individual protocol publications lack an evidence base.

Comments: starting from the first postoperative day, the physical and rehabilitation medicine physician / exercise therapy physician draws up an individualized rehabilitation program prescribing exercise therapy and physical therapy modalities: breathing exercises, active exercises for the joints of the healthy limb (hip, knee, ankle), isometric exercises for the muscles (gluteal, quadriceps, biceps femoris, calf muscles) of the operated limb, passive mechanotherapy (continuous passive motion [CPM] for the knee and ankle joints with increasing flexion angle), and positioning therapy for the knee and ankle joints [2, 14, 43].

Prevention of local complications includes reducing soft tissue edema and creating optimal anatomical and physiological conditions for the healing of tissues traumatized during surgery through cryotherapy, magnetotherapy, laser therapy, and ultraviolet irradiation (UVI) [43].

Patients with tibial shaft fractures after intramedullary nailing with proximal and distal locking by two screws may be allowed weight-bearing on the operated limb immediately after surgery, even in comminuted shaft fractures [2]. In patients after plate osteosynthesis, axial limb weight-bearing is not recommended for 6 to 8 weeks postoperatively [2, 20, 55]. In pediatric patients treated with titanium elastic nails (TEN), verticalization in the early postoperative period is permitted using auxiliary supports (crutches) and minimal weight-bearing—foot-floor contact of the operated limb for 6–8 weeks until radiological signs of callus formation are confirmed, with a gradual increase and restoration of weight-bearing on the operated limb.

Comments: Rigorous scientific justifications for various rehabilitation protocols are lacking. However, it has been shown that postoperative rehabilitation accelerates the recovery of limb function and improves the patient's quality of life [2, 14, 20, 43].

The rehabilitation program is drawn up by a medical rehabilitation physician / physical therapy physician based on knowledge of the mechanisms of action of physical exercises, massage, and physiotherapeutic factors. Every fracture is unique, so the rehabilitation program must be tailored to the individual characteristics of the patient. In accordance with clinical and radiological data, the following are prescribed: dynamic exercises to restore joint mobility, exercises with manual stretching of periarticular tissues, dynamic exercises with resistance and weight loading, static exercises to strengthen the foot and lower leg muscles; passive and active mechanotherapy, balance therapy, and proprioception training with biofeedback (exercise therapy for bone fracture, biofeedback training). Manual/ аппаратный massage of the leg, hardware lymph drainage, electrotherapy, and ultrasound therapy are prescribed [42, 55, 61, 75].

5. Prevention and Dispensary Observation

Prevention of tibia fractures consists in citizens following social safety rules when performing household chores, being in vehicle traffic areas, walking on poor-quality pavement and during icy conditions, and engaging in physical culture and sports.

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 hospital, the patient should be referred to a trauma center or outpatient trauma department, indicating the treatment performed and detailed recommendations for continuing treatment and rehabilitation. This will ensure continuity between the inpatient and outpatient stages of treatment.

Follow-up examinations with radiographs (radiography of the tibia and fibula diaphysis) and assessment of functional recovery dynamics are performed 6–8 weeks from the moment of injury or surgery (assessment of the degree of fracture consolidation and the possibility of full limb weight-bearing in extra-articular fractures), 12 weeks after injury or surgery (assessment of the degree of fracture consolidation and the possibility of limb weight-bearing in the presence of an intra-articular fracture component), 24 weeks after injury or surgery (assessment of the dynamics of functional recovery), 1 year after injury (assessment of the functional outcome of treatment and deciding on the need and timing of implant removal).

6. Organization of Medical Care

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

Purpose of the clinical guidelines: These clinical guidelines were developed to improve the quality of medical care and to standardize diagnostic and treatment algorithms for patients with femoral shaft and distal femoral fractures.

Indications for planned hospitalization:

1. Patients with a suspected fracture or a confirmed diagnosis of a tibial shaft fracture must be referred to a hospital for emergency hospitalization

Indications for emergency hospitalization:

• presence of complaints in the patient characteristic of a tibial shaft fracture;

• presence of characteristic clinical signs of a tibial shaft fracture;

• presence of radiological signs of a tibial shaft 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. Bozhkova S.A., D.Sc. in Medicine, Vreden National Medical Research Center of Traumatology and Orthopedics of the Ministry of Health of Russia, St. Petersburg, member of ATOR

3. Geroeva I.B., MD, DSc, Professor, National Medical Research Center of Traumatology and Orthopedics named after N.N. Priorov of the Russian Ministry of Health, Moscow.

4. Kleimenova E.B., MD, DSc, Professor, National Medical Research Center of Traumatology and Orthopedics named after N.N. Priorov of the Russian Ministry of Health, Moscow.

5. Mayorov B.A., Ph.D. in Medicine, Janelidze St. Petersburg Research Institute of Emergency Medicine, Pavlov First St. Petersburg State Medical University, St. Petersburg, member of ATOR

6. Nazarenko A.G., D.Sc. in Medicine, Professor of the RAS, Priorov National Medical Research Center of Traumatology and Orthopedics of the Ministry of Health of Russia, Moscow, Vice-President of ATOR

7. Novikov V.A., Ph.D. in Medicine, Turner National Medical Research Center for Children's Orthopedics and Trauma of the Ministry of Health of Russia, St. Petersburg.

8. Otdelenov V.A., PhD, National Medical Research Center of Traumatology and Orthopedics named after N.N. Priorov of the Russian Ministry of Health, Moscow.

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

Conflict of interest.

The working group for drafting clinical guidelines for the treatment of tibial shaft fractures has no conflict of interest.

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience for these clinical guidelines:

1. Trauma and orthopedic surgeons

2. Surgeons

3. Pediatric surgeons

4. General practitioners (family physicians)

5. Physical and rehabilitation medicine physicians.

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. Scale for assessing levels of evidence (LE) for diagnostic methods (diagnostic interventions).

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

Table 3. Scale for grading the levels of evidence (LE) 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 on 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 analgesia in major musculoskeletal trauma (surgical interventions for long bone fracture fixation or complex articular fracture, extensive soft tissue trauma, extensive surgical intervention, etc.) for adults

Appendix A3.2 Recommendations for analgesia in musculoskeletal trauma without surgery (closed fractures, superficial wounds, etc.) for adults

Appendix A3.3 Recommendations for postoperative analgesia in children

¹ In children under 12 years of age, morphine** is preferred when opioid analgesics are required, as the use of tramadol** is associated with a higher risk of adverse reactions [103, 104].

² Use in children is not recommended, as its metabolite accumulates in the body and provokes seizures with repeated use [105].

Appendix A3.4 Recommended doses, frequency, and route of administration of anticoagulants for prophylaxis at high risk of venous thromboembolism (VTE) during conservative treatment and in the preoperative period in adults

It should be noted that spinal or epidural anesthesia can be performed only 12 hours after the administration of a dose of low molecular weight heparins (LMWHs) from the heparin group (ATX code group B01AB) and no earlier than 4–6 hours after the administration of unfractionated heparin from the heparin group (ATX code group B01AB) (meanwhile, aPTT or ACT values must be within the normal range) [109, 110].

Appendix B. Physician Action Algorithms

Appendix B1. Physician action algorithms for suspected lower leg bone fracture

Appendix B2. Assessment of Cardiovascular Surgical Risk

Notes and abbreviations:

CVRF - cardiovascular risk factors (arterial hypertension, smoking, dyslipidemia (elevation of 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 atherosclerosis, chronic heart failure, pulmonary hypertension, valvular heart disease, cardiomyopathies);

rRCRI - reconstructed RCRI index (See Appendix G2);

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

*- regional vascular center or specialized cardiological department.

Appendix C. Patient Information

Tibial shaft fractures are severe injuries requiring specialized treatment in a traumatology department. Conservative treatment of such injuries is possible only in low-energy fractures without displacement or with minimal fragment displacement. This type of treatment involves prolonged immobilization with a plaster cast or its alternatives. Its main disadvantage is the increased duration of treatment and the need for prolonged rehabilitation, as immobilization results in contracture of the knee and ankle joints. Surgical treatment is indicated for the majority of fractures with fragment displacement. Various configurations of plates, intramedullary nails, and external fixation devices in various assemblies can be used to treat tibial shaft fractures. Treatment can be single-stage (in 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 injury). For these 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 that do not involve opening the fracture site are used for this purpose. In all cases, one should strive to perform stable osteosynthesis that does not require additional external immobilization after surgery. This makes it possible to start early rehabilitation treatment.

Rehabilitation treatment should be initiated immediately after surgery. It consists of passive and active movements in the lower limb joints, physiotherapeutic procedures, and exercises aimed at normalizing the trophic supply of the injured soft tissues and bone. The timing of weight-bearing permission on the limb may vary depending on the nature of the fracture and the method of its 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. Following osteosynthesis of similar fractures with plates, weight-bearing is permitted no earlier than 6–8 weeks postoperatively.

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

Appendix G1. Caprini Risk Assessment Scale for Venous Thromboembolism (Caprini J.)

Russian title: Caprini Individual Risk Assessment Scale for Venous Thromboembolism

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. Revised Cardiac Risk Index (rRCRI)

Russian title: Reconstructed Revised 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 [23] to predict the risk of perioperative cardiac complications in non-cardiac surgery. It was validated in the Lee study [105], and in 2013 [13] it was revised and re-validated based on clinical risk factors (the criterion "serum creatinine level >176.8 µmol/l" in the scale was replaced by "creatinine clearance <30 ml/min"; the clinical criterion "insulin-dependent diabetes mellitus" was removed), which is why it is called the reconstructed index. It includes 5 parameters, each assigned 1 point. This specific version of the index is recommended by the Russian Society of Cardiology [89].