Femoral shaft and distal femoral fractures (excluding proximal femur): clinical guidelines

List of Abbreviations

VKA – vitamin K antagonist

ACT – activated clotting time

EFA – external fixation apparatus

AO – Association for Osteosynthesis

aPTT – activated partial thromboplastin time

VTE – venous thromboembolism

DFE – distal femur

SSI – surgical site infection

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 heparins from the "heparin group" (ATX group code B01AB)

NSAIDs – non-steroidal anti-inflammatory drugs from the "non-steroidal anti-inflammatory and antirheumatic products" group (ATX group code M01A)

UFH – unfractionated heparin (sodium heparin**) from the "heparins group" (ATX group code B01AB)

PAI – fracture-related infection

SCT – spiral computed tomography

DVT – deep vein thrombosis

RF – risk factors

PRM – physical and rehabilitation medicine

FS – functional status

Surgical antibiotic prophylaxis

ECG – electrocardiography

DCS – Dynamic Condylar Screw

EAC – early appropriate care

LCP – Locking Compression Plate

LISS – Less Invasive Stabilization System

MAR – Metal Artifact Reduction

ORIF – Open Reduction Internal Fixation

Terms and Definitions

Internal fixator – an orthopedic implant placed during surgery that connects bone fragments in the treatment of fractures, deformities, or pseudoarthrosis.

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

Open fracture – a disruption of bone integrity accompanied by damage to the skin in the fracture area and injury to surrounding soft tissues.

External fixation device (EFD) – an orthopedic device containing an implant (a transosseous or extracorporeal element projecting 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, pseudoarthrosis, or gradual limb lengthening (correction of deformity).

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

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

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.

Absolute stability – the absence of micromotion at the fracture site, provided that anatomical bone reduction is achieved after fixation with hardware.

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.

Depression – the process of articular bone surface fracture formation due to excessive pressure from the articulating bone, where the impression zone separates from the main articular surface.

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).

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

Delayed/impaired consolidation – changes in the reparative regeneration of bone tissue manifested by a decrease in the rate or cessation of neo-osteogenesis, leading to the inability of the bone to perform its mechanical function.

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

Autologous bone graft – a fragment of the patient's own bone tissue harvested from a donor site for transplantation and/or to fill a bone tissue deficiency (bone defect).

Allogeneic bone graft – a bone tissue fragment from a living donor that has undergone a specialized preservation preparation procedure.

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

Patella – a large sesamoid bone enclosed in the tendon of the quadriceps femoris muscle.

Patellofemoral joint – a joint formed by the posterior articular surface of the patella and the patellar surface of the femur.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Diaphyseal and distal femoral fractures (DFE) – a non-classificatory term encompassing fractures of the upper, middle, and lower thirds of the diaphysis, as well as extra-articular and intra-articular fractures of the DFE. These fractures represent a disruption of femoral integrity in the diaphyseal or distal metaepiphyseal region. Based on the number of fragments, diaphyseal and DFE fractures are classified into simple and comminuted.

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

Diaphyseal and distal femoral fractures occur as a result of an external traumatic agent. Based on the mechanism of injury, direct and indirect forces are distinguished. In direct trauma, the force is applied directly to the fracture site. Indirect trauma is characterized by the application of force at a distance from the fracture site. Depending on the energy of injury, high-energy and low-energy fractures are distinguished. The former are typically the result of direct trauma and are accompanied by significant soft tissue damage. Low-energy fractures involve an indirect mechanism and occur in patients with reduced bone mineral density. Femoral shaft fractures are predominantly the result of high-energy trauma [1]. DFE fractures more commonly result from an indirect traumatic force. The most frequent are low-energy fractures caused by a fall from standing height onto the knee joint. High-energy trauma to the diaphysis and DFE occurs in motor vehicle accidents, falls from height, and sports [2].

1.3 Epidemiology of the Disease or Condition

The incidence of femoral shaft fractures is 10–37 cases per 100,000 population per year [3]. The distribution between high-energy and low-energy fractures is 48% and 35%, respectively, with a pre-hospital mortality rate of 17%. The age distribution of victims shows two peaks: young patients with high-energy trauma and patients over 65 years old with low-energy fractures. The latter are frequently peri-implant or periprosthetic [4].

Distal femoral fractures account for less than 1% of all bone fractures [5]. Among all femoral injuries, DFE fractures account for 0.4% to 7 according to various sources [6-10]. In polytrauma patients, the incidence of DFE fractures is much higher, reaching 13-17% of total femoral fractures [11]. In 84% of cases, patients with DFE fractures are older than 50 years. The average age of patients with DFE fractures is 62.2 years, including an average age of 44.0 years for male patients and 71.6 years for female patients. Moreover, fractures of this localization occur nearly twice as often in women as in men. There is an increased incidence of such fractures among individuals over 60, with a significant female predominance [2] and low-energy injuries resulting from falls from standing height. High-energy trauma due to falls from height or traffic accidents is predominantly characteristic of young male patients [10]. Furthermore, isolated DFE trauma in such victims is observed in only 20% of cases [1].

The most common causes of pathological fractures are osteoporosis, bisphosphonate therapy, glucocorticosteroid use, and oncological diseases [12]. When treating patients with pathological fractures, it is necessary to account for the underlying pathology that led to bone tissue alteration; therefore, pathological femoral fractures are not discussed in these clinical guidelines.

Features in children

Pediatric femoral fractures account for about 4% of all skeletal injuries. The majority of these involve the diaphyseal region. Distal femoral fractures, including metaphyseal fractures and growth plate injuries, are less common. Regarding age peaks, femoral fractures occur most frequently in children aged 2-3 years and 15-17 years [113].

1.4 Features of Coding the Disease or Condition

S72.3 – Fracture of shaft [diaphysis] of femur.

S72.30 – Closed fracture of shaft [diaphysis] of femur.

S72.31 – Open fracture of shaft [diaphysis] of femur.

S72.4 – Fracture of lower end of femur.

S72.40 – Closed fracture of lower end of femur.

S72.41 – Open fracture of lower end of femur.

S72.7 – Multiple fractures of femur.

S72.8 – Fractures of other parts of femur.

S72.9 – Fracture of unspecified part of femur.

T02.6 – Fractures involving multiple regions of one lower limb.

T02.3 – Fractures involving multiple regions of both lower limbs.

T02.5 – Fractures involving multiple regions of upper limb(s) and lower limb(s).

T93.1 – Sequelae of femoral fracture.

1.5 Classification of the disease or condition

Diaphyseal femoral fractures are classified into simple, wedge, and multifragmentary (complex) fractures.

Simple fracture – a fracture with a single line where the contact area between fragments after reduction exceeds 90%. Simple fractures are subdivided into spiral, oblique, and transverse or near-transverse.

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.

A comminuted (complex) fracture also involves 3 or more fragments, but unlike a wedge fracture, there is no contact between the main fragments after reduction. The intermediate fragment of a complex fracture may 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.

Metaepiphyseal fractures are divided into extra-articular and intra-articular. Intra-articular fractures, in turn, are subdivided into incomplete, where part of the articular surface remains intact and maintains continuity with the undamaged diaphysis, and complete, where the entire cross-section of the metaphyseal bone is damaged.

Diagnosis coding begins with determining the anatomical location of the fracture: bone and segment. According to the AO classification, the femur is designated by the number 3. The femoral diaphysis is coded as 32, and the distal femur as 33. Next, the morphological characteristics of the fracture are determined. This involves identifying the type, group, and subgroup of the fracture. All fractures are divided into 3 types: A, B, and C.

According to the AO universal fracture classification, femoral shaft fractures correspond to the code 32-.

Fractures of this localization are divided into the following groups:

32-A – simple fracture (Fig. 1):

32-A1 – simple spiral fracture;

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

32-A3 – simple transverse fracture (<30⁰).

a)

Figure 1. Simple fractures of the femoral shaft of type 32-A: a) 32-A1 – simple spiral fracture; b) 32-A2 – simple oblique fracture (> or = 30⁰); c) 32-A3 – simple transverse fracture (<30⁰) [14].

32-B – wedge fracture (Fig. 2):

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

32-B3 – wedge fracture, fragmented wedge.

a)

Figure 2. Wedge fractures of the femoral shaft of type 32-B: a) 32-B2 – wedge fracture, bending wedge, intact; b) 32-B3 – wedge fracture, fragmented wedge [14].

32-C – comminuted (complex) fracture (Fig. 3):

32-C2 – comminuted fracture with an intact segmental fragment;

32-C3 – comminuted fracture, irregular.

a)

Figure 3. Complex fractures of the femoral shaft of type 32-C: a) 32-C2 – comminuted fracture with an intact segmental fragment; b) 32-C3 – comminuted fracture, irregular [14].

According to the AO universal fracture classification, distal femoral fractures correspond to the code 33-. Fractures of this localization are divided into the following groups:

33-A – extra-articular fractures of the femur (Fig. 4):

33-A1 – avulsion fractures of the femoral epicondyles;

33-A2 – extra-articular simple distal femoral fractures;

33-A3 – extra-articular fractures with a metaphyseal wedge or complex distal femoral fractures.

a)

Figure 4. Examples of extra-articular distal femoral fractures of type 33-A: a) 33-A1 – avulsion fracture of the lateral femoral epicondyle; b) 33-A2 – extra-articular simple distal femoral fracture; c) 33-A3 – extra-articular fracture with a fragmented metaphyseal wedge [14].

33-B – partial articular fractures (Fig. 5):

33-B1 – incomplete articular fractures of the lateral femoral condyle;

33-B2 – incomplete articular fractures of the medial femoral condyle;

33-B3 – incomplete articular frontal fractures of the femoral condyles (Hoffer fractures).

a)

Figure 5. Examples of partial articular distal femoral fractures of type 33-B: a) 33-B1 – incomplete complex articular fracture of the lateral femoral condyle; b) 33-B2 – incomplete simple articular fracture of the medial femoral condyle; c) 33-B3 – bilateral incomplete articular frontal fracture of the femoral condyles (Hoffer fractures) [14].

33-C – complete articular fractures (Fig. 6):

33-C1 – simple articular fracture of the distal femur combined with a simple fracture of the metaphyseal part;

33-C2 – simple articular fracture of the distal femur combined with a complex fracture of the metaphyseal part;

33-C3 – articular comminuted fracture of the distal femur combined with a comminuted fracture of the metaphyseal part [14].

a)

Figure 6. Examples of complete articular distal femoral fractures of type 33-C: a) 33-C1 – complete simple articular fracture of the distal femur combined with a simple fracture of the metaphyseal part; b) 33-C2 – complete simple articular fracture of the distal femur combined with a complex fracture of the metaphyseal part; c) 33-C3 – complete articular comminuted fracture of the distal femur combined with a comminuted fracture of the metaphyseal part [14].

For open diaphyseal or distal femoral fractures, the R.B. Gustilo and J.T. Anderson classification (1976) as modified by R.B. Gustilo, R.M. Mendoza, and D.N. Williams (1984) is applied [15, 16]:

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.

Features in children

The classification of pediatric femoral shaft fractures is similar to that for adults. For distal femoral fractures, taking into account the presence of the growth plate, the Salter-Harris classification (1963) is used, which includes five types of injuries [114].

Figure: Diagram illustrating types of distal femoral injuries in children according to the Salter-Harris classification.

1.6 Clinical presentation of the disease or condition

The clinical presentation of femoral shaft and distal femoral fractures may be characterized by severe pain predominantly localized in the fracture zone; however, in the event of developed traumatic shock, the patient may not report pain. If fragment displacement is present, deformation at the fracture site is observed, and limb shortening of up to 8–10 cm is possible. Femoral shaft fractures are characterized by pathological mobility at the fracture site. Typical fragment displacement is caused by the pull of muscles attached to the femur. In fractures of the upper third of the diaphysis, the proximal fragment is displaced anteriorly and laterally, and the distal fragment upward, resulting in a characteristic angular deformity open medially. In middle-third diaphyseal fractures, the proximal fragment is displaced medially and posteriorly. In lower-third femoral fractures, the distal fragment is displaced posteriorly, while the proximal fragment lies anterior to it and slightly medially. In intra-articular fractures, smoothing of the knee joint contours due to hemarthrosis and patellar tap (ballotement) are determined [17].

If a diaphyseal or distal femoral fracture is suspected, all patients must be evacuated to a medical facility providing inpatient medical care to verify the diagnosis.

Complaints: pain in the thigh and/or knee joint area, impaired limb weight-bearing capacity, thigh or knee joint deformity, pain in wound areas (in open fractures).

Anamnesis: history of trauma; the patient describes a characteristic injury mechanism. If verbal contact with the patient is impossible due to concomitant diseases or the severity of the general condition (development of shock), the circumstances of the injury and, where possible, life anamnesis data are clarified from eyewitnesses or relatives of the patient. The mechanism of injury may be indirect – falling from a standing height onto the knee joint, falling from a height onto an extended lower limb, excessive frontal deviation of the lower leg. In some cases, a direct mechanism of injury may be observed – a direct blow by a traumatic agent to the middle or lower third of the thigh.

Objective findings: swelling of the thigh and/or the knee joint area and lower third of the thigh, limitation of active and passive movements due to severe pain, visually determined thigh deformity, varus or valgus deformity of the knee joint, tenderness on palpation of the middle or lower third of the thigh, patellar ballotement (hemarthrosis of the knee joint), bony crepitus, pathological mobility of the thigh at some level.

Features in children:

In young patients with non-displaced fractures, predominantly of the lower third of the femur, clinical symptoms may be relatively mild, and weight-bearing capacity may even be preserved. With such a clinical presentation, a bruise may be mistakenly diagnosed. Otherwise, the clinical presentation of femoral fractures shares common symptoms with the adult population [115].

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 findings: impaired function of the injured segment, limb deformity, pathological mobility and/or bone fragment crepitus, visually apparent bone fragments in the wound (in open fractures);

• instrumental examination findings: signs of femoral fracture based on radiography in 2 projections, spiral computed tomography (SCT), or MRI. When SCT of the injured segment is performed, radiography is not advisable. Additional SCT after radiography may be performed as prescribed by the on-duty or attending orthopaedic 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 the complaints described in section 1.6 "Clinical Presentation".

• All patients with suspected femoral shaft or distal third femoral fracture are recommended a thorough collection of complaints and anamnesis for diagnostic purposes [1, 5, 18].

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".

• In all patients with suspected femoral shaft or distal third femoral fracture, it is recommended to assess the following parameters for diagnostic purposes no later than 15 minutes after admission to the inpatient facility, with mandatory recording of the results in the medical record:

- assessment of somatic status;

- visual and palpation assessment of local status [19].

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

- blood pressure measurement;

- body temperature measurement;

- assessment of venous thrombosis risk and pulmonary embolism risk (Appendix G1) [20].

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

• All patients with suspected femoral shaft or distal third femoral fracture are recommended an assessment of innervation and blood circulation status in the injured limb to rule out neurovascular bundle injury at the fracture level, distally, or proximally to it [1, 5, 10, 18].

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

• All patients with suspected femoral shaft or distal third femoral fracture are recommended a clinical and instrumental assessment of soft tissue status and the severity of edema (measurement of thigh circumference and comparison with the contralateral limb, soft tissue and knee joint ultrasound, intercompartmental pressure measurement, thigh MRI) to rule out hematomas, hemarthrosis, developing compartment syndrome, and open fractures [133].

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

• When making a decision on surgical treatment for femoral shaft or distal third femoral fractures, it is recommended to collect anamnesis and perform a physical examination to identify risk factors and cardiovascular diseases [21, 22].

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

Commentary: Risk factors for cardiovascular disease 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) [21]. Established cardiovascular disease is defined as: coronary artery disease, cerebrovascular disease, peripheral artery disease, heart failure, pulmonary hypertension, valvular heart disease, cardiomyopathies [22, 23].

• All patients scheduled for elective surgical treatment of a femoral shaft or distal third femoral fracture are recommended an assessment of perioperative cardiovascular complication risk, taking into account the type of planned surgical treatment regardless of the presence of comorbidities [21, 24].

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%) [25].

2.3 Laboratory Diagnostics

• All patients diagnosed with a femoral shaft or distal third femoral fracture are recommended the following laboratory tests for diagnostic purposes:

- complete blood count;

- urinalysis;

- general clinical blood chemistry (total bilirubin in blood, aspartate aminotransferase activity in blood, alanine aminotransferase activity in blood, blood urea, blood creatinine, total protein in blood, blood glucose);

- lactate dehydrogenase activity in blood;

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

- hepatitis B virus surface antigen (HbsAg) in blood; antibodies to hepatitis C virus (Hepatitis C virus) in blood; antibodies to Treponema pallidum in blood,

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

- acid-base balance and blood gas analysis;

- coagulogram (screening hemostasis test);

- international normalized ratio (INR) determination [28-31, 131].

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

2.4 Instrumental Diagnostics

• All patients with suspected femoral shaft or distal third femoral fracture are recommended to undergo radiography of the femur and knee joint in two projections for diagnostic purposes [1, 5, 10, 18, 34].

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

Commentaries: Performing radiography of the femur including two adjacent joints is necessary to diagnose a shaft or distal third femoral fracture, determine the fracture pattern and degree of fragment displacement, and rule out injury to the segment at other levels [18, 34]. After confirming a shaft or distal third femoral fracture via 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 personal signature of the patient or their legal guardians (in case of legally established incapacity), followed by the transfer of an active patient call by the attending (on-duty) physician to the outpatient clinic at the patient's place of residence.

• All patients with a femoral shaft or distal third femoral fracture are recommended computed tomography of the lower extremity (femur, knee, and hip joints) in case of suspected intra-articular involvement of the distal third femoral fracture to clarify the diagnosis after initial fragment stabilization [1, 5, 10, 18, 34].

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

Commentaries: Lower extremity computed tomography (A06.03.036.001) provides the traumatologist with additional information on the fracture pattern, degree of fragment displacement, and severity of articular surface damage, thereby significantly improving the quality of preoperative planning [1, 5, 35, 36].

• All patients with a femoral shaft or distal third femoral fracture are recommended chest radiography to detect socially significant thoracic diseases and acute pulmonary pathology [17, 19]. If the patient is indicated for single-photon emission computed tomography combined with whole-body bone computed tomography (A07.03.004), chest radiography is not advisable.

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

• All patients with a femoral shaft or distal third femoral fracture are recommended vascular duplex ultrasonography (arteries and veins) of the lower extremity when impairment of major arteries and veins of the injured limb is suspected, to rule out major vessel injury and thrombosis [133].

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

• All patients with a femoral shaft or distal third femoral fracture are recommended echocardiography in the presence or suspected presence of acute cardiovascular pathology (unexplained dyspnea at rest; hypotension unresponsive to fluid therapy and requiring adrenergic and dopaminergic agents; electrocardiographic signs of myocardial ischemia; suspected pulmonary embolism, elevated NT-proBNP levels, left ventricular systolic dysfunction, cardiomyopathy, valvular heart disease) to determine management strategy and enable the earliest possible surgical treatment [23, 25, 40, 41].

GCR BLEL 4Grade of Recommendation B (Level of Evidence – 4).

• If acute or unstable clinical conditions are identified, it is recommended to postpone elective surgical treatment of a femoral shaft or distal femoral fracture until the patient's cardiac status improves and condition stabilizes; transfer of the patient to a regional vascular center or specialized cardiological department is indicated [25].

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

2.5 Other Procedures

Emergency specialist consultations in the preoperative period:

- anesthesiologist-resuscitologist consultation: to determine the presence or absence of indications for intensive therapy and to determine the feasibility of surgical intervention;

- neurosurgeon consultation: in case of nerve injury or suspected nerve injury and concomitant head trauma;

- surgeon consultation: in case of suspected acute surgical pathology, suspected or objectively diagnosed concomitant abdominal trauma;

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

- physician (internist) consultation: in the presence of concomitant medical conditions (according to medical history), as well as for a pre-surgical examination.

• In adult patients with a present or suspected remote acute or chronic purulent focus, or with a present or suspected fracture-related infection (FRI), it is recommended to apply an external fixation device (EFD) to stabilize bone fragments, followed by puncture of the purulent focus, microbiological (culture) examination of the purulent discharge for aerobic and facultatively anaerobic microorganisms, imaging and radioisotope studies, and debridement [132].

Grade CLevel 5Recommendation grade C (Level of evidence – 5).

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

3.1 Conservative Treatment

3.1.1 Pharmacotherapy

The main areas of medical treatment for a patient with femoral shaft or distal femoral fractures are adequate pain management, correction of fluid and electrolyte imbalances, prevention of venous thromboembolism (VTE), surgical antibiotic prophylaxis (SAP), antibiotic therapy for concomitant pathology, prevention of blood loss, and correction of anemia. In addition, based on indications, including the management of concomitant conditions, patients may receive supplementary drug therapy.

• All patients with femoral shaft or distal femoral fractures upon admission to the hospital are recommended to receive systemic analgesia, correction of hypothermia, as well as fluid and electrolyte imbalances in the emergency department to stabilize their general condition and prevent complications [133, 134, 135, 136].

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

Comments: Correction of fluid and electrolyte imbalances is carried out taking into account the patient's general condition, changes in homeostasis, acid-base balance, etc., at the time of admission to the hospital. Solutions affecting the water-electrolyte balance are used. Protecting the patient from body cooling using warm fluid infusions, warming blankets, and electric heaters reduces the risk of complications and helps decrease the volume of blood transfusion [45, 46, 47].

Postoperative pain management

• To achieve adequate pain relief in patients with femoral shaft or distal femoral fractures, it is recommended to use multimodal analgesia for adults and children, taking into account age restrictions, which may include NSAIDs (from the M01A group: Anti-inflammatory and antirheumatic products, non-steroids), paracetamol**, gabapentinoids (ATC group code N02BF), and immediate-release opioids (ATC group code N02A); if multimodal analgesia cannot be prescribed, monomodal analgesia should be used [48–50].

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

Comments:

Adequate pain relief must be provided to a patient with a fracture prior to any manipulations and throughout the entire fracture treatment period, the duration of which varies significantly depending on the chosen management strategy. When managing pain in an inpatient setting, it is necessary to take into account the prescriptions administered at the emergency medical care stage. In the acute phase of trauma, to achieve pain control, proper immobilization of the bone fragments must be provided using a vacuum splint, vacuum mattress, or external fixation device.

Among pharmacological strategies, the current consensus is the use of multimodal analgesia (MMA), which involves the use of several analgesics (opioids and other analgesics and antipyretics) with different mechanisms of action and non-pharmacological interventions aimed at targeting the peripheral and/or central parts of the nervous system [51]. This combination provides more effective pain relief by enhancing the effects of various drugs, which in most cases leads to a reduction in the frequency of prescriptions and/or doses of opioids. Thus, MMA lowers the risk profile of each drug while providing synergistic pain control using 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 [49, 52].

In modern scientific literature, authors emphasize the use of the lowest effective doses of opioids for the shortest possible period of time, avoiding extended-release opioids. As an adjuvant to MMA in adult patients, a single intravenous administration of #dexamethasone** 1.25–20 mg can be used before surgery (60 minutes prior to incision), which provides significant pain relief [48].

It must be kept in mind that the duration of parenteral administration of most NSAIDs from the ATC group M01A "Anti-inflammatory and antirheumatic products, non-steroids" (ketorolac**, ketoprofen**, diclofenac**) is limited to two days in accordance with the instructions for medical use, which requires timely switching of the patient to oral administration, changing the drug, or approving further use with the 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 are listed in Appendices A3.3–A3.5.

VTE prevention

Comments: To assess the patient's risk of VTE before surgery, it is advisable to use the Caprini risk assessment scoring scale (Appendix G1).

• All adult patients with distal fractures and subsequent internal fixation of the femur, in the absence of active bleeding, are recommended to undergo VTE prophylaxis until the patient's normal or expected mobility is restored [54, 141].

Level of Evidence BLevel of Confidence 2Level of recommendation B (level of evidence – 2).

Comments: Patients with femoral fractures are classified as a high-risk group for VTE due to the nature of the fracture itself, regardless of the treatment method; therefore, along with mechanical VTE prophylaxis, pharmacological prophylaxis is indicated for this category of patients. Non-pharmacological means of VTE prophylaxis include:

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

- early mobilization and activation of the patient;

- therapeutic exercise (physiotherapy).

Pharmacological VTE prophylaxis in the preoperative period is performed with unfractionated heparin (UFH, ATC: B01AB Heparin group) or, preferably, low-molecular-weight heparins (LMWH, ATC: B01AB Heparin group) [Appendix A3.2].

In pediatric patients with lower extremity fractures, the incidence of thromboembolic complications is about 0.058%. Adolescents with a femoral fracture fall into the risk group for this probability of embolism [116].

Recommended intervals between prophylactic anticoagulant administration and neuraxial interventions are given in Appendix A3.1.

• Patients receiving chronic antithrombotic therapy who present with a femoral shaft or distal femoral fracture are recommended to undergo VTE prophylaxis based on relevant clinical guidelines [20, 57-59].

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

• Patients with shaft and distal femoral fractures undergoing conservative treatment and limb immobilization are recommended to start VTE prophylaxis immediately after ruling out bleeding in order to prevent complications [20].

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

Comments. Recommended medicinal products and thromboprophylaxis regimens are provided in Appendix A3.3. The issues of VTE prevention in traumatology and orthopedics patients are discussed in detail in the 2022 clinical guidelines [20] and the 2023 Russian expert guidelines [58].

Features of thromboprophylaxis in pediatric patients

• In hospitalized patients older than 6 months, it is recommended to assess bleeding and VTE risks within 24 hours of admission [119] and periodically during the hospital stay [120-122].

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

Comment. No validated scales for assessing VTE risk in pediatric patients have been developed, nor for bleeding risk during anticoagulant therapy; therefore, when deciding to initiate VTE prophylaxis, individual bleeding risk factors (Appendix A3.6), VTE risk factors (Appendix A3.7), and the risk-benefit ratio should be considered [123, 125].

Mechanical and pharmacological methods are used for VTE prophylaxis in children.

• In pediatric patients at high risk for VTE, it is recommended to consider prescribing prophylactic doses of UFH or LMWH [142].

Level of Recommendation BLevel of Evidence 2Level of Recommendation B (Level of Evidence – 2).

Comment. LMWH is preferred for pediatric patients [127, 128], but currently in Russia the use of all LMWH in children is contraindicated, so their prescription is only possible by decision of a medical commission (off-label use). Some international guidelines mention the use of direct oral anticoagulants (rivaroxaban**) for VTE prophylaxis in children [125], however, there is currently insufficient clinical evidence of their efficacy and safety in this patient category [124, 126].

Surgical antimicrobial prophylaxis

• In the surgical treatment of patients with diaphyseal fractures or distal femoral fractures, it is recommended to perform surgical antibiotic prophylaxis (SAP) of surgical site infection with a single preoperative systemic administration of an antibacterial drug to reduce the risk of infectious complications [60, 61].

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

Comments. In accordance with international clinical guidelines for the prevention of surgical site infections [60, 62], the objective 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 necessity of SAP is determined by the surgical wound class of the upcoming procedure: SAP is not required for "clean" surgical wounds unrelated to the placement of orthopedic implants and metal hardware. SAP should be performed: for clean-contaminated and contaminated surgical wounds; for "clean" surgical wounds involving the placement of orthopedic implants and metal hardware. For infected ("dirty") wounds, SAP is not indicated; antibiotic therapy is administered instead.

• In patients with diaphyseal fractures or distal femoral fractures, it is recommended to use first- and second-generation cephalosporins (1st and 2nd generation, ATC J01DB, J01DC) (cefazolin**, cefuroxime**) as first-line drugs for surgical antibiotic prophylaxis during surgical interventions in traumatology and orthopedics, and glycopeptide antibacterial drugs (vancomycin**) or lincosamides (#clindamycin**) as alternatives in case of beta-lactam allergy [60].

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

Comments. For patients with an unburdened allergic history and no significant risk factors for methicillin-resistant Staphylococcus carriage, first- and second-generation cephalosporins (cefazolin**, cefuroxime**) are used for SAP, administered intravenously between 30 and 60 minutes before skin incision. In case of intolerance to beta-lactam antibacterial drugs, a combination of vancomycin** with one of the fluoroquinolones (ATC J01MA) (ciprofloxacin**, #levofloxacin**), administered over at least 60 min with the start of intravenous infusion 2 hours before incision, or #clindamycin** should be prescribed. In case of significant risk factors for methicillin-resistant Staphylococcus (MRS) carriage, the SAP regimen should include systemic antibacterial drugs (ATC: J01) with anti-MRS activity (vancomycin**). In most cases, a single preoperative dose of a systemic antibacterial drug is sufficient for effective prophylaxis. For prolonged procedures (more than 3 h) or massive blood loss, an additional intraoperative dose of a systemic antibacterial drug (ATC: J01) should be administered (approximate timing of intraoperative administration is 2 half-lives after the preoperative dose). Administration of systemic antibacterial drugs (ATC: J01) after wound closure in the operating room is inappropriate even if drains are present.

A prospective randomized clinical trial showed that administering an antibacterial drug for surgical site infection prophylaxis 1 minute after tourniquet inflation demonstrated a statistically significant advantage in reducing the incidence of surgical site infections, wound healing time, and overall patient satisfaction compared to antibiotic administration prior to tourniquet inflation [143].

Single doses of main antibacterial drugs for surgical site infection prophylaxis in adult traumatology and orthopedics: cefazolin** 2 g (for patient weight ≥120 kg – 3 g), cefuroxime** 1.5 g, #clindamycin** 900 mg, vancomycin** 15 mg/kg as a slow intravenous infusion, #ciprofloxacin** 400 mg, #levofloxacin** 500 mg [60]. 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 (ATC: J01MA) during the period of musculoskeletal system development is contraindicated due to the risk of arthropathy [60, 144, 145].

Comments. In open fractures, prophylactic antibiotic administration is effective in preventing early infection, and the drug should be administered as soon as possible after trauma. Cefazolin** is the antibiotic of choice, but for patients with open high-energy fractures with displacement and segmental 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 [64, 65]. An alternative to this combination for adults can be #ampicillin+sulbactam** (at a dose of 3.0 g every 8 hours for 3 days) [66]; the latter is particularly relevant when there is a risk of clostridial infection. According to most researchers, in Gustilo-Anderson type III open fractures, systemic antibacterial drugs should not be continued for more than 72 hours after soft tissue wound closure [67].

• In the surgical treatment of patients with closed distal femoral fractures, it is recommended to perform surgical site infection prophylaxis lasting no more than 24 hours [68, 69].

GRC ALOE 1Grade of Recommendation A (Level of Evidence – 1).

Comments. In accordance with current regulatory documents in the Russian Federation (SanPiN 3.3686-21) and clinical guidelines [70], to achieve an effective concentration of the antibacterial drug in tissues and blood at the time of skin incision, systemic antibacterial drugs for surgical site infection prophylaxis should be administered intravenously 30 to 60 minutes before skin incision, and vancomycin** should be administered within 2 hours before incision. The maximum duration of prophylactic systemic antibacterial drug administration should not exceed 24 hours after the end of surgery. In most cases, a single dose of a systemic antibacterial drug is sufficient for effective prophylaxis. Additional doses should be administered during prolonged surgeries when the half-life of the administered systemic antibacterial drug elapses from the moment of preoperative administration, creating a risk of the antibacterial drug concentration dropping below the bactericidal level and increasing the risk of surgical site infections.

Blood-conserving technologies

• For patients over 18 years of age at risk of bleeding during femoral fracture osteosynthesis, it is recommended to use perioperative tranexamic acid** (intravenous solution) for bleeding prevention [71].

GRC ALOE 1Grade of Recommendation A (Level of Evidence – 1).

Comments. Intravenous administration of tranexamic acid** is a generally accepted and effective method for significantly reducing blood loss and allogeneic blood transfusion in major orthopedic surgeries without increasing the risk of venous thromboembolism, acute coronary syndrome, cerebrovascular accident, wound complications, or mortality [72, 73]. Furthermore, randomized clinical trials demonstrate the efficacy of local subfascial administration of #tranexamic acid** (1.0 g in 10 ml) into the postoperative wound area, which is comparable to the intravenous administration of an equivalent dose of the drug [74, 75].

Comments. Systematic reviews and meta-analyses demonstrate that perioperative use of intravenous iron preparations, particularly 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, and leads to a lower incidence of infectious complications, though it does not affect mortality rates [76, 77].

3.1.2 Non-pharmacological treatment

Femoral shaft fractures

Femoral shaft fractures or distal femoral fractures are shock-inducing injuries; therefore, all patients with suspected or confirmed femoral shaft fractures or distal femoral fractures are immediately transferred to the trauma resuscitation room or intensive care unit upon admission to the hospital. All further resuscitation and diagnostic manipulations and procedures are performed in the trauma resuscitation room or intensive care unit until the patient is transferred to the operating room or ward.

• In patients with femoral shaft fractures to achieve bone union, it is recommended to use conservative treatment only in cases of the patient's voluntary refusal of surgical intervention. In all other cases, it is recommended to perform external fixation or internal osteosynthesis [1, 3, 18].

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

Comments: Immobilization of femoral shaft fractures using skeletal traction, plaster casts, polymer immobilizing bandages, and/or braces for hip and knee joint immobilization should be used only when osteosynthesis surgery cannot be performed. Preoperative immobilization may be performed using skeletal traction or an external fixation device, with external fixation being preferred. For high-energy injuries, open fractures, and femoral fractures as a component of polytrauma, the use of an external fixation device is mandatory for preliminary immobilization [1].

• In patients over 18 years of age with femoral shaft fractures, it is recommended in cases of conservative treatment of femoral shaft fractures to immobilize the injured extremity with a circular plaster cast or a skeletal traction system to achieve bone union [5, 18].

Level of Evidence BLevel of Confidence 2Level of recommendation B (level of evidence – 2).

Comments: When immobilizing with a skeletal traction system, pins (orthopedic bone wire***), Ilizarov pins (orthopedic bone wire***), Schantz screws, and Steinmann pins are used. When immobilizing with a circular plaster cast for up to 12-14 weeks, axial loading on the injured extremity must be excluded. Initial immobilization with a skeletal traction system may be replaced, if necessary, with immobilization using a plaster cast, polymer immobilizing bandage, or orthosis. Regardless of the immobilization method, the following complications may develop: knee and/or hip joint contractures, soft tissue neurotrophic disorders, pulmonary congestion, deep and superficial lower extremity vein thrombosis, and muscle hypo- or atrophy [18].

In the treatment of femoral shaft fractures or distal femoral fractures, double skeletal traction is applied according to the standard technique [79].

• In all adult patients with femoral shaft fractures, it is recommended as part of conservative treatment to perform control radiographs of the injured segment in two projections every 4–6 weeks to monitor the fracture consolidation process and the position of bone fragments [18].

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

Features in children

• In children with shaft fractures and distal femoral fractures without displacement, it is recommended to perform immobilization with slab or circular plaster casts, optionally polymer splints, to achieve bone union [117].

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

Comments: The treatment of femoral fractures in children is determined by the patient's age, fracture type, and the nature of the injury.

Closed femoral shaft fractures in children under 6–8 months of age are treated using an elevated splint. Residual fragment displacement by a full shaft width and at an angle of 15 degrees at the shaft level in this age category successfully remodels with age, and union occurs within 2–4 weeks.

In patients aged 6 months to 5 years, treatment is performed using traction systems (adhesive tape traction, skeletal traction). In this case, traction treatment can be used independently or as an initial stage. The latter option allows, upon achieving fibro-osseous union in a relatively early period, transferring the patient to a hip spica cast immobilization until complete consolidation is achieved in the fracture zone and reducing the hospital stay.

Distal femoral fractures

Previously conservative treatment was used in the following cases:

- undisplaced distal femoral fracture;

- distal femoral fracture in a patient on life support systems;

- distal femoral fracture in a bedridden patient with no potential for verticalization;

- distal femoral fracture in a patient with comorbid pathology that represents an absolute contraindication to surgery;

- upon the patient's voluntary refusal of surgical treatment [1, 5, 18].

These factors are currently not indications for conservative treatment.

• In adult patients with distal femoral fractures who choose conservative treatment, it is recommended to immobilize the injured limb with a splint, circular plaster cast, or skeletal traction system to create conditions for bone healing [5, 18].

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

Comments: Skeletal traction immobilization utilizes Kirschner wires*** (orthopedic bone wire), Ilizarov wires*** (orthopedic bone wire), Schanz screws, and Steinmann pins.

When immobilizing with a circular plaster cast for up to 12-14 weeks, axial loading on the injured limb must be avoided. Initial skeletal traction immobilization can be converted to plaster cast immobilization if necessary. Regardless of the immobilization method, the following complications may develop: knee contracture, pressure ulcers, pulmonary congestion, deep vein thrombosis of the lower extremities, and muscle atrophy [18].

• In adult patients with distal femoral fractures, it is recommended as part of conservative treatment to perform control radiographs of the injured segment in two projections every 4–6 weeks to monitor fracture healing and bone fragment position [18].

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

3.2 Surgical Treatment

• In the surgical treatment of patients with femoral shaft or distal femoral fractures, it is recommended to perform radiography of the femur of the operated segment in two projections or computed tomography of the lower extremity (A06.03.036.001) in MAR (Metal Artifact Reduction) mode to monitor reposition and osteosynthesis stability, as well as for treatment and follow-up evaluation over time [1, 17, 19].

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

• In patients with a femoral shaft or distal femoral fracture combined with a fracture of the bones of the leg on the ipsi- or contralateral limb, or combined with a fracture of the upper extremity(ies), it is recommended to prioritize femoral osteosynthesis to create conditions for femoral fracture consolidation and stabilize the patient's general condition; fixation of fractures in other locations should be performed according to current Clinical Practice Guidelines [1, 17, 19].

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

Comments: All extremity fractures concomitant with a femoral shaft or distal femoral fracture must be fixed using conservative or surgical methods. Depending on the patient's general condition, surgical stabilization of concomitant fractures may involve temporary (external fixation device) or definitive (external fixation device, internal osteosynthesis) fixation [1, 17, 19].

3.2.1 Femoral shaft fractures

3.2.1.1 Intramedullary Osteosynthesis

• In patients with femoral shaft fractures, the use of intramedullary osteosynthesis is recommended to create conditions for fracture consolidation [1].

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

Comments: Intramedullary osteosynthesis of the femoral shaft utilizes a non-sterile femoral intramedullary nail***, sterile femoral intramedullary nail***, non-absorbable orthopedic bone nail/rod***, non-sterile non-absorbable orthopedic bone screw***, and sterile non-absorbable orthopedic bone screw***.

Intramedullary osteosynthesis is indicated for the majority of femoral shaft fractures. It can be performed using either an antegrade or retrograde technique. Antegrade osteosynthesis is performed more frequently because this technique avoids intraoperative injury to the knee joint [80, 81].

Osteosynthesis using intramedullary nails involves their insertion with or without reaming of the medullary canal. Medullary canal reaming allows for the use of a larger-diameter intramedullary nail, which increases fixation stability by enhancing the mechanical strength of the implant and the contact area between the nail and the bone. Reaming also leads to increased blood circulation and oxygenation in adjacent tissues and systemic release of growth factors. Bone debris generated during reaming possesses osteoinductive and osteoconductive properties. Entering the fracture zone, this debris acts as an "autograft," stimulating osteogenesis [1, 82].

The design of intramedullary implants provides the option for static or dynamic locking. Dynamic locking is recommended for transverse and similar types of fractures. This locking mode provides interfragmentary compression under axial limb loading, thereby stimulating osteogenesis. Static locking is indicated for fractures with a tendency toward axial displacement under axial loading (oblique, spiral, comminuted, and severely comminuted fractures). In cases of delayed union, dynamization of the implant-bone system is indicated to optimize bone repair processes in the fracture zone. Dynamization is performed by removing the screw from the round hole of the intramedullary nail while retaining the screw inserted into its oblong hole, which allows axial displacement of the fragments [1]. Dynamization can be performed at the level of either the proximal or distal fragment, depending on the insertion method and nail modification.

• There are no absolute indications for retrograde osteosynthesis of the femoral shaft. When choosing the osteosynthesis technique for patients with femoral shaft fractures, it is recommended to consider the following relative indications for retrograde osteosynthesis:

- ipsilateral femoral shaft and neck fracture;

- ipsilateral femoral and tibial shaft fractures (allows insertion of femoral and tibial nails through a single surgical approach);

- hip region wound;

- presence of an implant or endoprosthesis in the proximal femur [1].

Features in children:

• Intramedullary osteosynthesis of closed diaphyseal femoral fractures in children aged 5–12 years and weighing up to 50 kg using elastic stable intramedullary nails is currently the method of choice. After closure of the growth plates, locked intramedullary femoral nailing can be used in adolescents [117, 118].

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

3.2.1.2 Plating (Plate Osteosynthesis)

• For patients with femoral shaft fractures, plate osteosynthesis is recommended to create conditions for fracture healing, taking into account the following relative indications:

- AO classification 32B or 32C fractures extending proximally to the trochanteric region or distally to the condylar region;

- narrow or deformed medullary canal;

- periprosthetic or peri-implant fractures;

- ipsilateral femoral neck and shaft fractures in cases where the femoral neck is fixed with a separate implant [1].

• Plate osteosynthesis in children aged 5–12 years may be used for unstable, comminuted femoral shaft fractures, as well as in children over 12 years of age weighing more than 50 kg with open growth plates that limit the use of locked intramedullary osteosynthesis [117, 118].

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

Comments: Plate osteosynthesis of the femoral shaft utilizes non-absorbable, sterile fracture fixation bone plates with screws***, non-absorbable, non-sterile fracture fixation bone plates with screws***, non-absorbable, non-sterile orthopedic bone screws***, and non-absorbable, sterile orthopedic bone screws***.

Traditional plate osteosynthesis with open exposure of the fracture site is rarely used in fresh injuries [1].

3.2.1.3 External Fixation Device

External fixation as a definitive method of osteosynthesis for femoral fractures may be associated with specific complications and limitations (pin-track infections, rehabilitation difficulties, patient inconvenience, etc.) and impairs the patient's quality of life.

As a rule, external fixation is used as a temporary (provisional) osteosynthesis method in cases of open fractures and polytrauma; furthermore, external fixation avoids the need for skeletal traction. Subsequently, after wound healing and stabilization of the patient's general condition, conversion to internal fixation is performed [83].

• For patients with an isolated femoral fracture or its combination with other injuries that do not affect the severity of their general condition, as well as in cases of femoral shaft fracture as a component of polytrauma in a stable patient where care can be provided in accordance with the early appropriate care (EAC) protocol, primary definitive osteosynthesis is recommended to create conditions for fracture healing [1, 83, 84].

GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)

• In pediatric patients, extrafocal osteosynthesis with external fixation devices is used in the management of multiple and associated injuries, as well as in open injuries that require wound inspection and management and limit the use of internal implants [117].

GDR CLE 5Grade of recommendation C (level of evidence – 5)

• For patients with a femoral fracture as a component of polytrauma in an unstable general condition, care in accordance with the damage control orthopedics (DCO) protocol and primary temporary external fixation with an external fixation device is recommended for temporary fracture stabilization and prevention of life-threatening complications [1, 83, 84].

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

Comments: In an unstable patient, the damage control strategy and primary external fixation are indicated. Severe concomitant chest and brain injuries may be an indication for the damage control strategy with primary temporary immobilization using an external fixation device; however, primary internal fixation in such cases also provides improved ventilation and normalization of intracranial pressure [3].

Temporary external fixation reduces operative time compared to primary internal osteosynthesis and also decreases interleukin-6 levels. Definitive internal fixation can be performed after the patient's condition has stabilized [83, 84, 85]. In cases of isolated femoral shaft fractures with technical feasibility, primary internal osteosynthesis is indicated. If primary internal osteosynthesis is not feasible, immobilization with an external fixation device or skeletal traction is performed, after which the patient is transferred to the trauma department. Skeletal traction immobilization, in the absence of technical feasibility for extrafocal fragment fixation, is permitted by decision of a medical board (consilium).

• For patients with femoral shaft fractures, the use of an external fixation device for definitive fragment fixation is recommended taking into account the following indications:

- presence of comorbid conditions determining the severity of the general condition;

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

- infection at the surgical site;

- extensive bone defects requiring reconstruction using bone lengthening technology [86].

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

• For patients with femoral shaft fractures, extrafocal osteosynthesis using pin-based external fixation devices, hybrid external fixation devices, or wire-based external fixation devices (set of components and parts for an external fixation device with installation tools) is recommended [1, 84, 86].

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

• For patients with femoral shaft fractures undergoing extrafocal osteosynthesis using a pin-based external fixation device (set of components and parts for an external fixation device with installation tools), inserting at least 3 pins into both the proximal and distal fragments is recommended to achieve adequate fixation stability. For subtrochanteric femoral shaft fractures, a pelvis-femur external fixation configuration is used [1, 83, 84].

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

3.2.2 DFJ fractures

Surgical fixation of distal femoral fractures, compared to conservative methods, improves functional treatment outcomes, achieves better restoration of distal femoral anatomy, helps reduce patient rehabilitation time, and decreases the severity of post-traumatic knee joint contractures.

Surgical treatment of patients with distal femoral fractures can be performed in 1 or 2 stages. In closed fractures without extensive soft tissue damage, internal osteosynthesis can be used as the primary and definitive method of fracture fixation. If primary internal osteosynthesis is contraindicated due to the patient's general condition or the nature of the injury, a two-stage treatment strategy is applied, whereby the definitive fracture fixation surgery is preceded by temporary immobilization using an external fixation device or skeletal traction [1].

• Patients with distal femoral fractures are recommended to undergo surgical treatment to create conditions for bone union [1].

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

• For patients with distal femoral fractures requiring osteosynthesis, immobilization of bone fragments, and creation of conditions for bone union, it is recommended to use external fixation devices (EFD), intramedullary nails, and plates for plate osteosynthesis (anatomically pre-contoured distal femoral plates with angular screw stability) [1, 87, 88].

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

3.2.2.1 External Fixation Device

• Patients with distal femoral fractures, including older children and adolescents, are recommended to use pin EFDs, hybrid EFDs, wire EFDs (a set of components and parts for an external fixation device with installation tools) for both temporary and permanent stabilization of the distal femoral fracture as a provisional fixation method in uncomplicated fractures, as well as in open fractures with massive soft tissue damage or neurovascular bundle injury in the fracture zone, in patients with severe conditions, or as part of a damage control protocol in polytrauma patients [1, 10, 18, 87].

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

Comments: The main purpose of using external osteosynthesis in these cases is to ensure stability in the fracture zone, reduce pain, restore limb length and axis, and eliminate gross rotational displacement of the fragments. When installing a pin EFD (a set of components and parts for an external fixation device with installation tools) for distal femoral fixation, manual axial traction of the limb must be performed to eliminate gross fragment displacement. Then, 2 Schanz pins are inserted along the anterior surface of the thigh proximal to the fracture zone. It should be noted that the insertion of Schanz pins through intermuscular spaces must be performed after manual distraction of the distal femoral fracture, otherwise the pins will hinder distraction. Distally, at least 2 pins are inserted into the tibia along the anteromedial surface, after which the external fixator is assembled, spanning the knee joint [1, 89].

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

• Patients with distal femoral fractures are recommended to transition from external to internal fixation once soft tissue conditions normalize and the patient's general condition stabilizes, in order to create conditions for bone union [89].

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

Comments: The transition to internal fixation in polytrauma patients is preferably performed after stabilization of the patient's general condition. Long-term postponement of surgery not only increases the technical complexity of the procedure but also raises the risk of complications [90].

• Patients with distal femoral fractures are recommended to use hybrid EFDs and wire EFDs (a set of components and parts for an external fixation device with installation tools) for definitive fracture fixation [86, 91, 92].

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

Comments: For extra-focal osteosynthesis of a distal femoral fracture, EFDs can be used either with or without spanning the knee joint. Using an EFD as the definitive treatment method allows for excellent and good functional results. Anatomical restoration of the articular surface is possible through the use of wires with stopper olive tips. However, this method carries the risk of several potential complications: septic arthritis, osteomyelitis, pin-tract infection, loss of reduction, delayed union or nonunion requiring bone grafting, and knee joint contracture [93].

3.2.2.2 Intramedullary Osteosynthesis

Many traumatologists choose intramedullary osteosynthesis for distal femoral fractures due to the minimally invasive nature of this procedure, the possibility of early weight-bearing on the operated limb, and, consequently, faster patient rehabilitation. Retrograde intramedullary nailing technique is preferred, although antegrade nail insertion is also feasible.

• Patients with distal femoral fractures are recommended to undergo retrograde locked intramedullary osteosynthesis to create conditions for fracture consolidation in AO types 33-A2, 33-A3, 33-C1, and 33-C2 distal femoral fractures [93-96].

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

Comments: Intramedullary osteosynthesis utilizes non-sterile femoral intramedullary nail***, sterile femoral intramedullary nail***, non-absorbable orthopedic bone nail***, non-absorbable orthopedic bone screw, non-sterile***, and non-absorbable orthopedic bone screw, sterile***.

Antegrade fixation can be performed for type 33-A fractures with the fracture line located 5 cm or more proximal to the articular surface of the femoral condyles [92, 93]. The advantages of this technique include smaller surgical incisions and no need to perform knee joint arthrotomy. Antegrade intramedullary osteosynthesis for intra-articular distal femoral fractures must include anatomical reduction of the articular surface fragments and their fixation with additional lag screws [10, 92].

• Patients with distal femoral fractures are recommended to undergo retrograde intramedullary osteosynthesis to create conditions for fracture consolidation in AO types 33-A2, 33-A3, 33-C1, and 33-C2 distal femoral fractures [1, 34, 87, 88, 97].

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

Comments: Intramedullary osteosynthesis utilizes non-sterile femoral intramedullary nail***, sterile femoral intramedullary nail***, non-absorbable orthopedic bone nail***, non-absorbable orthopedic bone screw, non-sterile***, and non-absorbable orthopedic bone screw, sterile***.

Modern intramedullary implants are inserted through small surgical incisions, which reduces intraoperative soft tissue trauma and avoids opening the fracture site, thereby lowering the risk of bone fragment devitalization. This technique allows for early partial weight-bearing on the injured limb, facilitating faster patient rehabilitation. The retrograde intramedullary nail is inserted into the medullary canal of the femur via an infrapatellar surgical approach. In cases of intra-articular fractures, prior to opening the medullary canal and inserting the implant, osteosynthesis of the femoral condyles with lag screws is performed to minimize secondary fragment displacement during intramedullary nail insertion [1, 10, 18].

• Patients with distal femoral fractures are recommended to undergo retrograde intramedullary osteosynthesis to create conditions for bone union in the following cases:

  • distal femoral fracture in a polytrauma patient;

  • ipsilateral proximal or diaphyseal femoral fracture;

  • floating knee joint (ipsilateral lower extremity bone fractures);

  • distal femoral fracture in an obese patient [1, 10, 98].

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

Comments: The minimally invasive nature of femoral intramedullary osteosynthesis allows this technique to be used for fracture stabilization in polytrauma patients. When a distal femoral fracture is combined with an ipsilateral lower leg fracture, simultaneous intramedullary osteosynthesis of both fracture sites through a single surgical approach can be performed [10, 98].

• Adult patients with distal femoral fractures sre recommended [Note: typo in prompt 'рекомендуется' translated as recommended] to use wires or screws that functionally narrow the medullary canal and promote controlled nail positioning (so-called poller screws/wires or TMS) for more accurate restoration of the limb axis to achieve the correct position of the intramedullary nail in the wide part of the distal fragment during its retrograde or antegrade insertion [99, 100].

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

Comments: Non-absorbable orthopedic bone screw, non-sterile***, non-absorbable orthopedic bone screw, sterile***, and wire*** are used as poller screws.

Since the diameter of the medullary canal in the distal femur is much larger than the diameter of the implant, difficulties in nail positioning often arise during osteosynthesis. The use of poller screws or Kirschner wires functionally narrows the medullary canal, thereby simplifying reduction and improving the radiological outcome of treatment. Poller screws or wires are placed on the concave side of the deformity [100].

• In patients with distal femur fractures, to facilitate the reduction of bone fragments, it is recommended to use additional reduction aids, such as an external fixator, a large distractor, Schanz pins as joysticks, various reduction forceps, and an orthopedic table [18, 100].

GDR CLE 5Grade of recommendation C (level of evidence – 5)

Comments: The distal femoral fragment is small in size, and the displacing forces of the muscles attached to it are quite high. Therefore, in some cases, closed reduction is extremely difficult. The techniques described above are designed to facilitate reduction and improve its quality.

3.2.2.3 Plate Osteosynthesis

• In patients with distal femur fractures, it is recommended to use plate fixators (95-degree blade plates, DCS plates, or anatomically pre-contoured plates with or without angular stability of screws, anatomically pre-contoured plates with polyaxial screw insertion capability) to create conditions for fracture healing [1, 10, 18, 87, 89, 100].

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

Comments: For plate osteosynthesis of distal femur fractures, the following are used: non-absorbable sterile bone fracture fixation plate***, non-absorbable non-sterile bone fracture fixation plate***, non-absorbable non-sterile orthopedic bone screw***, non-absorbable sterile orthopedic bone screw***.

The condylar buttress plate is an anatomically pre-contoured plate and can be either with or without angular stability of the screws. Its design allows several screws to be inserted into the femoral condyles, which expands the surgeon's capabilities in fragment fixation and promotes the creation of absolute stability in the intra-articular fracture zone. However, it is worth noting that the absence of angular stability of the screws can lead to fixation failure under cyclic loads and loss of reduction, manifested as varus deformity of the distal femur.

Anatomically pre-contoured metal implants with angular stability of screws, as well as with the possibility of polyaxial screw insertion, are preferred in the treatment of patients with distal femur fractures. Locking screws inserted into the metaphyseal part of the plate provide full fixation of fragments, and when inserted into the diaphyseal part, they allow fixation using a minimally invasive technique. If interfragmentary compression of the articular component of the fracture is necessary, it is achieved by the preliminary insertion of lag screws outside the plate. In addition, one of the advantages of plates with angular stability of screws is the absence of the need to press the latter against the bone, which helps preserve periosteal blood flow [101].

In the case of complex distal femur fractures with a loss of medial stability, an additional medially positioned plate can be used. This design increases the stability of the implant-bone system and promotes fracture healing. The additional medial plate can be implanted using a minimally invasive surgical technique from two mini-approaches along the medial surface of the femur [102].

Features in children

• In children over five years of age with displaced diaphyseal and distal femoral fractures, it is recommended to perform reduction (closed/open) and osteosynthesis to achieve bone union [117].

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

In children with displaced distal femur fractures, the goal of treatment is to eliminate the existing displacement and ensure the retention of fragments until union:

• For metaphyseal fractures without complete rupture of the cortices, accompanied by angular displacement, closed fragment reduction is recommended.

• For displaced type I–II epiphyseolysis and osteoepiphyseolysis, it is also recommended to perform closed reduction of fragments and their percutaneous cross-pinning under fluoroscopic control.

• For metaphyseal fractures with complete displacement of fragments across the entire diameter, open reduction with pin fixation or plate osteosynthesis is recommended.

• If closed reduction is ineffective in type I and II epiphyseolysis and osteoepiphyseolysis, or in cases of type III and IV injuries, open reduction and internal fixation are recommended [114, 117].

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

3.3 Other Treatment

Comments: In accordance with clauses 4156-4157 of the Sanitary Rules and Norms on the Prevention of Infectious Diseases (SanPiN 3.3686-21), emergency tetanus prophylaxis is carried out for any injuries involving a breach of the skin and mucous membranes. Emergency tetanus prophylaxis is carried out up to the 20th calendar day from the moment of injury [103]. The prescription of drugs for emergency tetanus immunoprophylaxis is carried out differentially, depending on the availability of documentary confirmation of preventive vaccination or immunological monitoring data on 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 anti-tetanus immunoglobulin** (HATI), and in its absence, with tetanus antitoxin** (TAT);

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

- emergency revaccination with tetanus toxoid** (or diphtheria-tetanus toxoid** with a reduced antigen content – DT-toxoid-M) to stimulate immunity in previously vaccinated individuals [103, 104].

4. Medical Rehabilitation and Sanatorium-Resort Treatment

• Postoperative mobilization of the patient and restoration of the range of motion in the hip and knee joints should be started as early as possible. Patient activation is recommended to begin within 24 hours after surgery [1, 105].

GGR CLEL 3Grade of Recommendation C (Level of Evidence – 3)

Patients with diaphyseal and extra-articular distal femur fractures, after stabilization with an intramedullary nail with proximal and distal locking by two screws, are allowed to bear weight on the operated limb immediately after surgery, even in comminuted diaphyseal fractures [106]. In patients after plate osteosynthesis, axial loading on the limb is not recommended for 6-8 weeks after surgery [1].

In traumatology, the course of exercise therapy is divided into 3 periods:

1. Early postoperative period.

2. Late postoperative period.

3. Recovery period.

Main tasks of physical rehabilitation:

1. restoration of the disturbed balance of core central nervous system functions;

2. enhancement of the patient's general vitality, improvement of mood, and elimination of "psychogenic inhibition";

3. improvement of cardiovascular, respiratory, digestive, and excretory system function;

4. elimination of congestion in the thoracic organs (prevention of hypostatic pneumonia), abdominal cavity, and pelvic region.

5. active prevention of local complications;

6. improvement of trophic processes in tissues: stimulation of general and local blood and lymph circulation, enhancement of metabolic processes, and stimulation of tissue regeneration (formation of functionally adequate bone, scar, and other tissues at the injury sites);

7. restoration of impaired musculoskeletal functions.

General principles of physical rehabilitation:

1. Early (timely) initiation – from the first days of the patient's admission to the hospital to eliminate or reduce the manifestations of the body's general response to trauma and prevent the effects of physical inactivity.

2. Continuity throughout the entire course of treatment (physical rehabilitation is an integral part of comprehensive treatment).

3. Combination of exercise therapy with immobilization.

4. Gradual increase in physical load.

5. Multidisciplinary approach – combining physical exercises with massage, mechanotherapy, balneotherapy, occupational therapy, etc.

Contraindications for prescribing exercise therapy in trauma patients:

1. Severe general condition of the patient caused by blood loss, shock, infection, psychological trauma, or concomitant pathology.

2. Persistent and pronounced pain syndrome.

3. Body temperature above 37.5°C.

4. Presence of foreign bodies near major blood vessels, nerves, and other vital organs.

The principles of rehabilitation for patients with femoral fractures include: early weight-bearing, emphasis on knee range of motion to prevent contractures, and maintaining ankle and hip range of motion to prevent contractures and improve venous return (thrombosis prophylaxis).

Early postoperative period (Phase 1: 0–14 days)

Goals of rehabilitation in the early postoperative period:

• reduction of pain and edema;

• early passive mobilization of the knee and ankle joints;

• verticalization, early weight-bearing with crutches.

During this period:

• Local cold therapy.

• From the first day after surgery, the patient is prescribed active exercises for the joints of the healthy leg (hip, knee, ankle), isometric exercises for the muscles of the operated limb (gluteal, quadriceps, hamstrings, calf muscles), passive exercises and positioning on a functional splint with a gradual increase in the flexion angle in the operated joint.

• Exercise therapy is prescribed on days 2–3 (in the absence of contraindications). Emphasis is placed on assisted passive-active movements along a sliding surface.

• During the first week of rehabilitation (first 5–7 days), a sparing physical activity regimen is indicated. To prevent postoperative complications, breathing exercises are performed, and the operated limb is placed on a Bohler splint to prevent edema. Exercises are prescribed to improve blood and lymph circulation as well as the functional state of the lower extremity and trunk (antigravity) muscles.

During therapeutic exercise, the onset or intensification of pain must be avoided, as pain causes reflex muscle tension, making the exercises more difficult to perform. When selecting exercises, one should consider facilitators such as sliding planes, roller boards, etc., as well as the site of injury, the simplicity or complexity of movements, and the level of activity.

Crutch walking with minimal weight-bearing on the operated limb is permitted (the degree of weight-bearing depends on the fracture pattern and type of osteosynthesis).

Late postoperative period (Phase 2: 2–8 weeks postoperatively)

Goals of rehabilitation in the late postoperative period:

• pain reduction;

• restoration of range of motion in the hip, knee, and ankle joints;

• restoration of muscle strength in the operated lower extremity.

Manual therapy techniques are applied: patellar mobilization, soft tissue mobilization, and surgical scar mobilization.

Recovery period (Phase 3: 8–16 weeks)

Goals of rehabilitation in the recovery period:

• return to full functional activity.

Exercises during this period focus on strengthening the pelvic girdle muscles, training the weight-bearing capacity of the operated lower extremity, stretching, and plyometrics.

Physical therapy modalities.

Aimed at reducing pain and edema, suppressing inflammation, improving trophic supply and metabolism of bone and soft tissue in the fracture zone, eliminating muscle hypotrophy, resolving contractures, improving weight-bearing capacity and relieving stiffness in adjacent joints, and adapting to daily physical activities.

The tasks of the early postoperative period (from surgery to 2 weeks) are: prevention of postoperative cardiovascular, respiratory, and gastrointestinal complications, prevention of trophic disorders, pain reduction, soft tissue edema reduction, and creation of optimal anatomical and physiological conditions for the healing of tissues traumatized during surgery [107]. Ultraviolet irradiation of the surgical wound, magnetotherapy, and pulsed currents are used during this period [108].

The tasks of the late postoperative period (2–12 weeks post-surgery) include pain relief, edema reduction, tissue trophic improvement, surgical scar mobilization, prevention of joint contractures, strengthening of the pelvic girdle and thigh muscles, restoration of weight-bearing capacity, and correction of gait biomechanics [107, 108]. Infrared laser therapy (intra-articular laser therapy A22.04.001), low-frequency magnetotherapy (general magnetotherapy A17.30.025), muscle electrical stimulation, general medical massage / medical lower extremity massage, pulsed current electrophoresis, ultraviolet irradiation of the injury site (A22.04.004 Ultraviolet irradiation for joint diseases), symmetrical or reflexogenic zone, therapeutic underwater jet massage, and hyperbaric oxygenation for crush syndrome (A20.30.028) are used during this period [107-109].

The use of physical therapy procedures is indicated in the absence of contraindications as prescribed by a physical therapist.

5. Prevention and Dispensary Observation

Prevention of femoral fractures consists in citizens observing social safety rules when performing household chores, being in traffic areas, walking on poor-quality 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: Upon discharge from the hospital, the patient should be referred to a trauma center, outpatient trauma department, district surgeon, or local outpatient surgeon with a description of the treatment performed and detailed recommendations for continuing treatment and rehabilitation. This ensures continuity of care between the inpatient and outpatient stages.

Follow-up examinations with X-rays or multislice computed tomography (MSCT), including metal artifact reduction (MAR) mode, and evaluation of functional recovery dynamics are performed at 6–8 weeks postoperatively (assessment of fracture consolidation and feasibility of full weight-bearing on the limb in extra-articular fractures), 12 weeks postoperatively (assessment of fracture consolidation and feasibility of weight-bearing on the limb in intra-articular fractures), 24 weeks postoperatively (assessment of functional recovery dynamics), and 1 year postoperatively (assessment of the functional outcome of treatment and decision-making regarding the necessity 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 suspected or confirmed femoral fractures must be referred to a hospital for emergency admission.

Indications for emergency hospitalization:

1) presence of patient complaints suggestive of a femoral fracture;

2) presence of characteristic clinical signs of a femoral fracture;

3) presence of radiographic signs of a femoral fracture.

Indications for patient discharge from the hospital:

1. Internal fixation of the fracture with metal hardware, stabilization with an external fixation device, or immobilization with a plaster cast, synthetic cast, or orthosis in conservative treatment has been performed.

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 cases of legally established incapacity) to continue inpatient treatment (the reason for refusal must be documented in the medical chart and signed by 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., MD, Associate Professor, Vreden National Medical Research Center of Traumatology and Orthopedics of the Ministry of Health of Russia, St. Petersburg, member of ATOR

3. Vasil'kin A.K., PhD, Vreden National Medical Research Center of Traumatology and Orthopedics of the Ministry of Health of Russia, St. Petersburg, member of ATOR

4. 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.

5. Dubrov V.E., MD, Professor. Faculty of Fundamental Medicine, Lomonosov Moscow State University, Moscow, member of ATOR

6. Zorin V.I., PhD, Associate Professor, Turner National Medical Research Center for Children's Orthopedics and Trauma of the Ministry of Health of Russia, St. Petersburg.

7. 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.

8. Mayorov B.A., PhD, Saint Petersburg Dzhanelidze Research Institute of Emergency Medicine, St. Petersburg, member of ATOR

9. Nazarenko A.G., MD, Professor of RAS, Director of the Priorov National Medical Research Center of Traumatology and Orthopedics of the Ministry of Health of Russia, Moscow, Vice President of ATOR.

10. Naumenko M.V., PhD, Deputy Chief Physician of Inozemtsev City Clinical Hospital of the Moscow Healthcare Department, member of ATOR

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

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

13. Shelupaev A.A., Staff member of the Organizational and Methodological Department for Traumatology and Orthopedics, Research Institute for Healthcare Organization and Medical Management of the Moscow Healthcare Department, member of ATOR

Conflict of interest.

The working group on drafting clinical guidelines for the treatment of femoral shaft and distal femoral fractures has no conflicts of interest.

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience for these clinical guidelines:

1. Orthopedic trauma surgeons

2. Surgeons

3. Pediatric surgeons

3. General practitioners

4. Anesthesiologists-intensivists

5. Transfusiologists

6. Physical medicine and rehabilitation doctors

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

1. Definition of search criteria and selection of publications on clinical trials (CTs) 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 established 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 certainty (LEC) 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 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, including compliance of indications and contraindications, routes of administration, and drug doses with the drug's instructions for use

Appendix A3. Reference Materials

Appendix A3.1. Recommended intervals between prophylactic anticoagulant administration and neuraxial interventions in adult patients

Time restrictions between neuraxial intervention and anticoagulant administration are presented in accordance with the European Guidelines on Perioperative VTE Prophylaxis [146].

Appendix A3.2. Recommended dosing regimen of low molecular weight heparins for high-risk VTE prophylaxis in conservative treatment and orthopedic surgery in adult patients at high risk of VTE

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 (while aPTT or ACT values must be within the normal range) [147, 148].

Appendix A3.3. Pain management guidelines for major musculoskeletal trauma (surgical interventions for long bone fracture fixation or complex articular fracture, extensive soft tissue trauma, major surgery, etc.) in adults

The table presents analgesic medications and their dosing regimens in accordance with the Clinical Guidelines for Pain Management in Acute Musculoskeletal Trauma [137].

Appendix A3.4. Pain management guidelines for non-surgical musculoskeletal trauma (closed fractures, superficial wounds, etc.) in adults

The table presents analgesic medications and their dosing regimens in accordance with the Clinical Guidelines for Pain Management in Acute Musculoskeletal Trauma [137].

Appendix A3.5 Analgesic dosing regimen for children

¹ In children under 12 years of age, morphine** is the preferred choice when opioid analgesics are indicated, as the use of tramadol** is associated with a higher risk of adverse reactions [138, 139].

² Use in children is not recommended, as its metabolite accumulates in the body and provokes seizures upon repeated use [140].

Appendix A3.6. Risk factors for bleeding in children from 6 months to 18 years

Notes:

1. If the patient meets at least one "NOT recommended" criterion, avoid pharmacoprophylaxis, as the risk outweighs the benefit.

2. If the patient has at least one relative contraindication criterion, consider withholding pharmacoprophylaxis.

3. Consider consultation with a hematologist if the patient is at high risk for VTE with a high bleeding risk [146].

4. Uncontrolled hypertension is defined as systolic or diastolic blood pressure above the 95th percentile for age, height, and sex [147].

5. Coagulopathy is defined as INR >1.5, aPTT >44 s, fibrinogen <100 mg/dL, or platelets <50,000/μL.

Appendix A3.7. VTE Risk Factors in Children Aged 6 Months to 18 Years

Notes:

− Reduced mobility is defined as a decrease in mobility compared to baseline or the inability to participate in physical therapy.

− A central venous access device is defined as a non-tunneled catheter, tunneled catheter, or central venous catheter.

− A major burn is defined as a burn involving more than 50% of the body surface area.

− Major surgical procedures include operations lasting longer than 45 minutes.

− Critically ill patients are defined as those admitted to an intensive care unit (requiring inotropic support or mechanical ventilation).

− Thrombophilic states include antithrombin deficiency, protein C or S deficiency, factor V Leiden, or prothrombin gene mutation.

− Active malignancy is defined as receiving chemotherapy/radiation therapy within the preceding 6 months.

− Active inflammatory disease includes Kawasaki disease, inflammatory bowel disease, systemic lupus erythematosus, or nephrotic syndrome.

− Estrogen therapy includes oral contraceptives, estrogen replacement therapy, or use within the past 2 weeks.

− Obesity is defined as a BMI above the 95th percentile for age.

Key:

Low VTE risk:

• No altered mobility and 0-1 risk factors

Moderate VTE risk:

• No mobility impairment and 2-3 risk factors

• Altered mobility and 0-1 other risk factors

High VTE risk:

• No mobility impairment and ≥4 risk factors

• Altered mobility and ≥2 other risk factors

Thromboprophylaxis recommendation

Appendix B. Physician Action Algorithms

Appendix B1. Algorithm of actions upon admission of a patient with suspected femoral 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 artery disease, chronic heart failure, pulmonary hypertension, valvular heart disease, cardiomyopathies);

rRCRI – reconstructed RCRI index;

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

* – regional vascular center or specialized cardiology department.

Appendix C. Patient Information

Femoral shaft fractures are fractures affecting predominantly the middle part of the femur. Distal femoral fractures are fractures of the lower third of the femur. Both types of fractures represent severe trauma requiring specialized inpatient care. Conservative treatment of such injuries has numerous drawbacks and is therefore practically obsolete today. One of the disadvantages of conservative treatment is the extended duration of treatment and the need for prolonged rehabilitation, as immobilization results in contracture of the hip, knee, and ankle joints.

As a rule, patients with such fractures require surgical treatment—osteosynthesis. Prior to surgery, temporary immobilization of the injured limb is necessary using skeletal traction or an external fixation device. In patients with a severe general condition, temporary immobilization is performed exclusively using an external fixation device.

For the treatment of shaft fractures and extra-articular distal femoral fractures, plates of various configurations, intramedullary nails, and various types of external fixators can be used. Treatment can be single-stage (in isolated closed fractures and satisfactory soft tissue condition) or 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). In most cases, minimally invasive osteosynthesis techniques are used, avoiding exposure of the fracture site. Intra-articular fractures require complete restoration of the anatomy of the injured joint. To achieve this, surgical exposure of the fracture site and direct visual reduction of the fragments are usually necessary. Following osteosynthesis, no additional immobilization cast is required. This allows early mobilization and rehabilitation.

Rehabilitation treatment should be initiated immediately after surgery. It consists of passive and active range-of-motion exercises for the lower limb joints, physical therapy, and exercises aimed at improving blood supply and nutrition to the injured soft tissues and bone. The timing of weight-bearing on the limb may vary depending on the fracture pattern and fixation method. Typically, after intramedullary nailing of extra-articular fractures, partial weight-bearing is permitted in the first days post-surgery. Following osteosynthesis of similar fractures with plates, weight-bearing is permitted no earlier than 6–8 weeks post-surgery. If the fracture is intra-articular, weight-bearing is delayed further and is allowed no earlier than 3 months from the time of surgery.

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

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

Name in Russian: Caprini Risk Assessment Model for Individual Risk of 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 stratification of the risk of postoperative venous thromboembolism in a high-risk group. Khirurgiya. Zhurnal im. N.I. Pirogova. 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 > 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 point;

• moderate risk: 2 points;

• high risk: 3–4 points;

• very high risk: 5 points or more