Humeral shaft fractures: clinical guidelines

List of Abbreviations

EFA – external fixation apparatus

AO – Association for Osteosynthesis

VTE – venous thromboembolism

DHU — distal humerus

HSH – humeral shaft fracture

RTA – road traffic accident

CT – computed tomography

HDL – high-density lipoproteins

LDL – low-density lipoproteins

PT – physical therapy

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

INR – international normalized ratio

MRI – magnetic resonance imaging

LMWH – low-molecular-weight heparin

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

UFH – unfractionated heparin (sodium heparin) from group B01AB Heparin and its derivatives

TAT – tetanus antitoxin

HTIG – human tetanus immunoglobulin

WDE – wound debridement and excision

SCT – spiral computed tomography

DVT – deep vein thrombosis

RF – risk factors

PRM – physical and rehabilitation medicine

FS – functional status

Surgical antibiotic prophylaxis

TENS – transcutaneous electrical nerve stimulation

ECG – electrocardiography

LCP – locking compression plate

MIPO – minimally invasive plate osteosynthesis

ORIF – open reduction internal fixation

TEN – titanium elastic nail for intramedullary osteosynthesis in children

K-wire – Kirschner wire for bone fragment stabilization in children

Terms and Definitions

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

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

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

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 – absence of micromotion at the fracture site, provided there is anatomical reduction and interfragmentary bone compression 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.

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

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

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

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

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

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

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Humeral shaft (HSH) fractures encompass fractures of the upper, middle, and lower thirds of the diaphysis. These fractures represent a disruption of the structural integrity of the humerus within the diaphyseal region due to trauma. According to the number of fragments, HSH fractures are classified into simple and comminuted.

In young children, greenstick subperiosteal fractures should be distinguished.

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

HSH fractures result from the impact of a high-force external traumatic agent. Based on the trauma mechanism, direct and indirect impacts are distinguished. In a direct trauma mechanism, the force is applied directly to the fracture site. The indirect trauma mechanism is characterized by the traumatic force being applied at a distance from the fracture site. Depending on the energy of the injury, high-energy and low-energy fractures are distinguished [14]. The former occur as a result of motor vehicle accidents, falls from a height, railway accidents, and occupational injuries. They typically result in a direct impact on the humeral diaphysis and are accompanied by significant damage to surrounding soft tissues with a potential injury to major vessels and nerves [102]. First and foremost, this concerns the radial nerve due to the specifics of its topography [40]. Fractures resulting from high-energy trauma are transverse, multi-comminuted, or segmental [14, 17, 26]. Low-energy fractures have an indirect trauma mechanism and most often occur due to rotational forces, resulting in spiral and comminuted fractures [14, 17, 26]. An example in young patients is a sports injury—a fracture of the lower third of the HSH during arm wrestling. In elderly patients, HSH fractures often occur against the background of reduced bone mineral density [128].

1.3 Epidemiology of the Disease or Condition

The prevalence of humeral shaft fractures accounts for 3-5% of all skeletal bone fractures [17, 26, 103]. Of these, about 10% are open [99]. The incidence rate of these injuries is 14.5-20 per year per 100,000 population [30], of which 60% of fractures occur in the middle third of the diaphysis, 30% in the proximal, and 10% in the distal third [99]. At the same time, there are significant differences in the trauma mechanism depending on the patient's sex and age. In young patients (age peak 20-30 years), HSH fractures are the result of high-energy trauma, can be open, are frequently combined with other injuries, and prevail in men. In elderly patients with osteoporosis, HSH fractures occur due to low-energy trauma, most often from a standing height fall. In this patient group, 75% are women, with an age peak of 60-70 years [99, 128].

1.4 Features of Coding the Disease or Condition

S42.3 – Fracture of shaft of humerus.

1.5 Classification of the disease or condition

Diaphyseal fractures of the humerus are divided into simple, wedge, and multi-comminuted (complex).

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 close to them; in younger children, these are greenstick or subperiosteal fractures.

Wedge fracture contains 3 or more fragments. After reduction of this fracture, its main fragments are in contact with each other. The wedge can be intact or fragmented.

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

To accurately determine the anatomical localization 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 wedge fractures, 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 boundaries of the fracture.

Diagnosis coding begins with determining the anatomical localization of the fracture: bone and segment. According to the AO classification, the humerus is assigned number 1. The humeral shaft is coded as 12. Next, the morphological characteristics of the fracture are determined. This involves identifying the fracture type, group, and subgroup. All fractures are subdivided into 3 types: A, B, and C.

According to the universal AO fracture classification, humeral shaft fractures correspond to code 12-. Fractures of this localization are divided into the following groups:

12-A – simple fracture:

12-A1 – simple spiral fracture;

12-A2 – simple oblique fracture (> or = 30^°);

12-A3 – simple transverse fracture (< 30^°);

12-B – wedge fracture:

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

12-B3 – wedge fracture, fragmented wedge;

12-C – multi-comminuted (complex) fracture:

12-C2 – multi-comminuted fracture with an intact segmental fragment;

12-C3 – multi-comminuted irregular fracture.

For open humeral shaft fractures, the classification by R.B. Gustilo and J.T. Anderson (1976), modified by R.B. Gustilo et al. (1984), is applied [46, 47].

Type I – open fracture, wound mildly contaminated, wound size less than 1 cm.

Type II – open fracture, wound greater than 1 cm and less than 10 cm in length without extensive soft tissue damage, flaps, or skin avulsion.

Type IIIA: open fracture with soft tissue coverage of the bone fragments, no periosteal stripping despite extensive soft tissue damage or the presence of flaps, or resulting from high-energy trauma regardless of the wound size.

Type IIIB: open fracture with extensive soft tissue defect, periosteal stripping, and comminuted fracture pattern, frequently accompanied by significant wound contamination.

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

1.6 Clinical presentation of the disease or condition

The clinical presentation of humeral shaft fractures is characterized by pronounced pain syndrome at the fracture site, tenderness upon palpation and axial load. When fragment displacement is present, shortening of the upper extremity, visible angular deformity at the fracture site, and pathological mobility of bone fragments are detected. In fractures of the upper third of the diaphysis, the proximal fragment is displaced anteriorly and laterally, and the distal one – superiorly, developing a characteristic angular deformity open medially. In fractures of the middle third of the diaphysis, displacement of the proximal fragment medially and posteriorly occurs. In humeral fractures in the lower third, varus deformity of the diaphysis is characteristic, while damage to the radial nerve in the area of the lateral intercondylar groove is possible due to excessive traction or entrapment between the ends of the bone fragments [31]. This type of fracture is described in the literature as a Holstein-Lewis fracture, named after the authors who described it in 1963 [54].

If an HSH fracture is suspected, the patient must be referred to a medical organization to verify the diagnosis.

Complaints: pain in the shoulder region, pathological mobility, shoulder deformity, pain in wound areas (in open fractures). In case of radial nerve injury, complaints include the absence of active extension of the wrist, fingers, and abduction of the thumb, as well as sensory impairment in the skin of the radial side of the dorsum of the hand.

A specific feature in younger children is crying and restlessness.

Anamnesis: history of trauma; the patient describes a characteristic mechanism of injury. The trauma mechanism can be indirect – falling from a standing height onto the elbow joint. Indirect trauma mechanisms also include fractures during arm wrestling caused by excessive rotational force acting on the humerus while the elbow joint is fixed. In the case of a motor vehicle accident, a fall from a height with landing on the shoulder area, a railway accident, or criminal assault, a direct mechanism of injury may be observed—the impact of a traumatic agent directly on the shoulder area. With such a trauma mechanism, soft tissue injuries, including radial nerve injury, are more likely [90, 102].

Physical examination: edema of the shoulder and elbow joint regions, limitation of active and passive movements due to severe pain syndrome, visually determined shoulder deformity, tenderness upon palpation in the shoulder area, bone fragment crepitation, pathological mobility of the shoulder [142]. In case of radial nerve dysfunction, deficits in wrist extension, finger extension, 1st finger abduction, forearm supination, and sensory impairment in the zone of autonomous innervation of the radial nerve—the skin of the dorsal aspect of the radial side of the hand in the projection of the 1st and 2nd metacarpal bones—are detected [142]. Given the probability of radial nerve dysfunction, neurological status assessment is mandatory when an HSH fracture is suspected. In addition, in the case of a high-energy trauma mechanism, injury to the brachial artery must be ruled out [26]. For this purpose, peripheral arterial pulsation is assessed on the radial artery at the typical site of the wrist joint region.

Children may only present with a forced position of the upper extremity.

2. Diagnostics, medical indications and contraindications for diagnostic methods

Criteria for establishing the diagnosis/condition:

• history data: indication of a characteristic mechanism of upper extremity trauma (fall, blow to the respective segment, traffic accident, etc.);

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

• instrumental examination data: radiographic signs of a fracture based on X-ray results in two projections. Additional CT may be performed as prescribed by an orthopedic trauma surgeon to clarify the nature of the fracture and determine the degree of fragment displacement.

2.1 Complaints and Anamnesis

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

2.2 Physical Examination

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

• The evaluation of the following parameters is recommended no later than 1 hour after hospital admission, with mandatory documentation of the results in the medical record:

  - assessment of somatic status;

  - visual and palpation assessment of local status [140, 142].

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

• blood pressure measurement;

• body temperature measurement;

• assessment of the risk of venous thrombosis and pulmonary embolism (Appendix G2) [117].

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

• When deciding on surgical treatment for a humeral shaft fracture, it is recommended to collect an anamnesis and perform a physical examination to identify risk factors and cardiovascular diseases, as well as to take into account the child's age [11, 49].

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

Comment: Cardiovascular disease risk factors include: arterial hypertension, smoking, dyslipidemia (elevated total cholesterol >4.9 mmol/L and/or LDL cholesterol >3 mmol/L and/or HDL cholesterol in men <1.0 mmol/L, in women – <1.2 mmol/L 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) [49]. Established cardiovascular disease is understood to include: coronary artery disease, cerebrovascular disease, peripheral atherosclerosis, chronic heart failure, pulmonary hypertension, valvular heart disease, and cardiomyopathies [11, 29].

• All patients scheduled for elective surgical treatment of a humeral shaft fracture are recommended to undergo perioperative cardiovascular risk assessment based on the planned type of surgery, regardless of the presence of comorbidities [43, 49].

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

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

Minor orthopedic surgeries carry a low risk of cardiovascular complications (30-day risk of myocardial infarction or cardiovascular death after surgery – less than 1%). Major orthopedic surgeries carry an intermediate (moderate) risk of cardiovascular complications (30-day risk of myocardial infarction or cardiovascular death after surgery – 1-5%) [135].

• To assess the risk of perioperative cardiovascular complications, it is recommended to use a special algorithm [Appendix G3] [35, 135].

BMR BLEL 3Level of recommendation validity B (level of evidence – 3).

• Elective surgical treatment for a humeral shaft fracture is recommended without additional testing in patients whose cardiovascular risk is assessed as low. In patients with an intermediate or high perioperative risk of cardiovascular complications, assessment of the patient's functional status is recommended [93, 135].

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

2.3 Laboratory Diagnostics

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

  - complete blood count (CBC);

  - urinalysis;

  - general clinical blood biochemistry analysis;

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

  - hepatitis B surface antigen (Australian antigen, HBsAg);

  - antibodies to hepatitis C virus (Anti-HCV);

  - screening for antibodies to Treponema pallidum in the 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;

  - coagulogram (screening hemostasis test);

  - determination of the international normalized ratio (INR) [71, 76, 126].

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

• When deciding on surgical treatment for a humeral shaft fracture in adult patients, it is recommended to test blood levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in cases of intermediate or high risk of cardiovascular complications and low functional status (see Appendix G2) [49, 84, 110, 135].

Leveled Evidence 2Strength of Recommendation A (Level of Evidence – 2).

2.4 Instrumental Diagnostics

Comments: Performing radiography of the humerus capturing two joints is necessary to diagnose a humeral shaft fracture, determine the fracture pattern and the degree of fragment displacement, and rule out injury to the segment at other levels. Once the humeral shaft fracture is confirmed by imaging, the issue of hospitalization is addressed. The patient should be hospitalized if surgical treatment is planned. If conservative treatment is chosen, upper extremity immobilization may be applied. The method of primary immobilization will be described below in the section on conservative treatment.

• In the presence of clinical signs of radial nerve neuropathy, it is recommended to perform an ultrasound examination of peripheral nerves to diagnose injury or interposition within the humeral shaft fracture [50, 91].

LE 3Recommendation Grade B (Level of Evidence – 3).

• In the presence of clinical signs of distal upper extremity ischemia, it is recommended to perform vascular ultrasound (arteries and veins) of the upper extremity and/or computed tomography angiography of upper extremity vessels to diagnose injuries or compression of major blood vessels [4, 73].

LE 3Recommendation Grade B (Level of Evidence – 3).

Comments: CT angiography is becoming a widespread method for arterial visualization [37], which may be indicated by weakened or absent pulsation of forearm arteries. The sensitivity and specificity of CT angiography according to a meta-analysis of 11 moderate-quality studies were 96.2% (95% CI 93.5-97.8%) and 99.2% (95% CI 96.8-99.8%), respectively [59].

2.5 Other Procedures

• In case of acute or unstable clinical conditions, it is recommended to postpone elective surgical treatment of the distal radius fracture until the cardiac status improves and the patient's condition stabilizes; transfer of the patient to a regional vascular center or a specialized cardiology department is indicated [135].

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

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

3.1 Conservative Treatment

• For patients with humeral shaft fractures upon admission to the hospital, the following minimum scope of care in the emergency department is recommended:

  - ensuring thermal comfort for the patient;

  - adequate pain management;

  - immobilization of the injured upper extremity;

  - correction of fluid and electrolyte imbalances [136, 140, 142].

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

Comments: Conservative treatment consists of closed reduction of bone fragments in fractures under local anesthesia with the administration of local anesthetics into the perigraft hematoma, closed manual reduction of fragments, and immobilization. Fragment displacement with arm shortening of up to 3 cm, rotational displacement of up to 30°, and angular deformity of 20° is considered acceptable [14, 17, 26].

In children, conservative treatment consists of closed reduction of bone fragments in fractures under general anesthesia; in adolescents over 15 years of age, local anesthesia with the administration of local anesthetics into the perifracture hematoma, closed manual reduction of fragments, and immobilization may be used. Fragment displacement with arm shortening of up to 3 cm, rotational displacement of up to 30°, and angular deformity of 20° is considered acceptable.

Immobilization of the injured upper extremity is carried out using various types of fixing bandages. The type of bandage used depends on the individual characteristics of the patient and the preferences of the attending physician. A hanging plaster cast and a U-shaped plaster slab must immobilize the shoulder and elbow joints for 7–14 days until edema subsides and pain decreases [3, 97].. Subsequently, most specialists recommend changing the fixing bandage to a functional brace according to A. Sarmiento (1977) with the release of the shoulder and elbow joints and early initiation of active movements [74, 85–87, 132]. The duration of brace fixation is about 8 weeks. The use of this technique is especially effective in fractures of the middle third of the diaphysis, provided that a satisfactory position of the bone fragments is maintained, when the proportion of good and excellent results of the method reaches 88%. When the fracture is localized in the upper and lower thirds of the diaphysis, the effectiveness of conservative treatment is lower and does not exceed 75% [97].

Postoperative analgesia

• For adequate pain relief in patients with distal radius fractures, it is recommended to use multimodal analgesia, which may include nonsteroidal anti-inflammatory drugs (NSAIDs), paracetamol**, gabapentinoids, and immediate-release opioids, taking into account age restrictions in the instructions for medical use; if its prescription is impossible, monomodal analgesia is indicated [14, 40, 102].

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

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

Cast immobilization may be used in children.

Among pharmacological strategies, multimodal analgesia (MMA) is currently universally accepted. It involves the use of several analgesic drugs (opioid and non-opioid) with different mechanisms of action, along with non-pharmacological interventions aimed at targeting the peripheral and/or central parts of the nervous system in adults, and adapted for age in children [17]. This combination provides more effective pain management by enhancing the effects of various drugs, which in most cases leads to a reduction in the prescription frequency and/or doses of opioid analgesics. Thus, MMA improves the risk profile of each drug while providing synergistic pain control using different classes of medications. Postoperative MMA may include psychotherapy, physical therapy, NSAIDs, paracetamol**, gabapentinoids, regional anesthesia (single-shot injection or peripheral nerve catheter placement), local injections, and opioids [26, 102].

In modern scientific literature, authors emphasize the use of the lowest effective doses of opioids for the shortest possible duration, avoiding extended-release opioids. A single perioperative dose of #dexamethasone** can be used as an adjuvant during MMA, which provides a significant reduction in pain [14].

It must be remembered that the duration of parenteral administration of most NSAIDs (ketorolac**, ketoprofen**, diclofenac**) is limited to two days, which requires timely switching of the patient to oral administration, changing the drug, or coordinating 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 based on the child's weight and age. Preference should be given to analgesics with oral or rectal administration routes, avoiding intramuscular injections, although the route of administration should also be chosen based on the child's condition.

Comments. Recommended analgesic drugs are listed in Appendices A3.1-A3.3.

Prevention of venous thromboembolic events

Comments: Patients with humeral fractures may belong to the moderate or high VTE risk group, depending on patient characteristics, the nature of the trauma sustained (multiple and polytrauma carry a higher DVT risk), and the planned duration of surgery. Along with mechanical VTE prophylaxis, medical prophylaxis is indicated for this category of patients. Non-pharmacological means of VTE prophylaxis include:

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

- Early mobilization and activation of the patient;

- Therapeutic exercise.

Comments. Given the growing population of carriers of genetically determined thrombophilias (antithrombin III, protein C, or S deficiency, factor V Leiden mutation, prothrombin G20210A mutation, etc.), the widespread use of estrogens, population aging, and the rising incidence of diabetes and other metabolic disorders that increase VTE risk, pharmacological thromboprophylaxis may be advisable when treating patients with additional risk factors for VTE who present with shoulder fractures or extensive soft tissue trauma of the upper extremities. The final decision is made by the attending physician, taking into account the extent of the injury and the nature of the planned procedure.

Perioperative administration of LMWH according to the regimens and dosages specified in Appendix A3.4 is possible for 7–10 days (until discharge from the hospital) or for several days until normal/expected physical activity is restored.

Recommended medications and thromboprophylaxis regimens are given in Appendix A3.4.

The issues of VTE prophylaxis in trauma and orthopedic patients are discussed in detail in the 2022 guidelines [116] and the 2023 Russian expert guidelines[133].

Specific aspects of VTE prophylaxis in pediatric patients

• Hospitalized patients older than 6 months are recommended to undergo bleeding and VTE risk assessment within 24 hours of hospitalization [144] and periodically during their hospital stay [145–147].

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

Commentary. No validated VTE risk assessment scales have been developed for pediatric patients, nor have scales for bleeding risk assessment during anticoagulant therapy; therefore, when deciding on VTE prophylaxis, individual bleeding risk factors (Appendix A3.5), VTE risk factors (Appendix A3.6), and the risk-benefit ratio should be considered [148, 150].

For VTE prophylaxis in children, mechanical and pharmacological methods are used.

• Pediatric patients at high risk for VTE are recommended to consider administration of prophylactic doses of UFH or LMWH.

GCP BLeE 3Level of recommendation confidence B (level of evidence reliability – 3).

Commentary. LMWH is preferred for pediatric patients [152, 153], but currently in Russia, the use of all LMWHs is contraindicated in children; therefore, their administration 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 [150], but currently there is insufficient clinical evidence regarding their efficacy and safety in this patient population [151]. Risk factors for VTE and bleeding are presented in Appendices A3.5 and A3.6.

Surgical antibiotic prophylaxis

• When surgically treating patients with closed proximal humerus fractures, it is recommended to perform surgical antibiotic prophylaxis (SAP) for surgical site infections by a single preoperative administration of an antibacterial drug [42].

GCR ALEL 1Grade of Recommendation A (Level of Evidence – 1)

Commentaries. In accordance with international clinical guidelines on the prevention of surgical site infections [13, 141], 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 need for SAP is determined by the surgical wound class of the upcoming operation: SAP is not required for "clean" surgical wounds not associated with the placement of orthopedic implants and metal structures. SAP should be performed: for clean-contaminated and contaminated surgical wounds; for "clean" surgical wounds involving the placement of orthopedic implants and metal structures. SAP is not indicated for infected ("dirty") wounds; antibiotic therapy is performed instead.

Commentaries. For patients with an uncomplicated allergic history and without significant risk factors for methicillin-resistant Staphylococcus aureus carriage, first- and second-generation cephalosporins (cefazolin**, cefuroxime**) are used for SAP, administered intravenously 30 to 60 minutes before skin incision. In case of beta-lactam intolerance, a combination of vancomycin** with one of the fluoroquinolones (ciprofloxacin**, #levofloxacin**) administered over at least 60 minutes with the intravenous infusion starting 2 hours before the incision, or #clindamycin** should be prescribed. In the presence of significant risk factors for methicillin-resistant Staphylococcus aureus (MRS) carriage, the SAP regimen should include an antibiotic with anti-MRS activity (vancomycin**). In most cases, a single preoperative dose of the antibiotic is sufficient for effective prophylaxis. For prolonged procedures or massive blood loss, an additional intraoperative dose of the antibiotic should be administered (approx. timing of intraoperative administration: 2 half-lives after the preoperative dose). Postoperative administration of the antibiotic in the operating room after wound closure is inappropriate, even in the presence of inserted drains.

Single doses of main antibacterial drugs for SAP in adult traumatology and orthopedic surgery: cefazolin** 2 g (if patient weight ≥120 kg — 3 g), cefuroxime** 1.5 g, #clindamycin** 900 mg, vancomycin** 15 mg/kg as a slow IV infusion, ciprofloxacin** 400 mg, #levofloxacin** 500 mg. [13]. Single doses for children should be calculated by actual weight in accordance with the attached drug insert: cefazolin** 30–50 mg/kg, cefuroxime** 50 mg/kg, #clindamycin** 10 mg/kg, vancomycin** 15 mg/kg; the use of fluoroquinolones during the period of bone and joint system development in the presence of open growth plates is contraindicated due to the risk of arthropathy [13, 156, 157].

Commentaries. In case of open fractures, prophylactic antibiotic administration is effective in preventing early infection. Antibiotics should be administered as soon as possible after trauma; cefazolin** is the antibiotic of choice, but in patients with open high-energy fractures with displacement and segmental bone loss, major vessel injury, or heavily contaminated wounds, it is advisable to broaden the spectrum of prescribed antibiotics to cover Gram-negative pathogens. In such cases, adult patients may be considered for the addition of #gentamicin** (at a dose of 6 mg/kg once daily) to cefazolin** [53, 94]. An alternative to this combination may be #ampicillin+sulbactam** (at a dose of 3.0 g every 8 hours for 3 days) [98], the latter being particularly relevant in case of risk of clostridial infection. According to the majority of researchers, in Gustilo and Anderson type III open fractures, antibiotics should not be continued for more than 72 hours after soft tissue wound closure [75].

Blood-saving techniques

Commentaries. Tranexamic acid** effectively reduces blood loss and leads to a smaller decrease in postoperative hemoglobin levels in patients who underwent surgery for proximal humerus fractures. This effect is observed both during fracture osteosynthesis and shoulder arthroplasty. Randomized clinical trials demonstrate the efficacy of local subfascial administration of #tranexamic acid** (1.0 g in 10 mL) into the surgical wound area, comparable to intravenous administration of an equivalent dose [41].

Commentaries. Systematic reviews and meta-analyses demonstrate that perioperative use of intravenous iron preparations, specifically ferric carboxymaltose**, in trauma and orthopedic patients, especially in the postoperative period, is an effective alternative to blood transfusion, as it reduces the proportion of patients receiving blood transfusions, decreases the volume of packed red blood cells transfused, and reduces the incidence of infectious complications, without affecting mortality rates [60, 92].

Evidence of the efficacy of intravenous iron preparations for correcting preoperative iron deficiency anemia in elective orthopedic procedures has been obtained in the pediatric population [158, 159]. Data on the use of these drugs in children during the postoperative period following trauma surgery are absent.

3.2. Surgical treatment

Indications for surgical treatment of patients with humeral shaft fractures are divided into relative and absolute. Absolute indications include fractures with damage to major vessels and nerves, open and gunshot fractures, fractures as part of polytres, and ipsilateral fractures of the humerus and forearm bones. Relative indications include significant displacement of bone fragments, shortening of the humerus by more than 3 cm, rotational displacement of more than 30° and angular displacement of more than 20°, fragmentary, pathological, and bilateral fractures of the humerus, as well as a combination of fractures with traumatic plexopathy of the brachial plexus or radial nerve neuropathy that appeared after fracture manipulation [14, 17, 26]. Due to the high risk of nonunion, relative indications for surgical treatment also include transverse, short oblique fractures of the middle third of the humeral shaft, and long oblique fractures of the upper third of the shaft extending to the proximal humerus, where there is a high probability of soft tissue interposition [36, 37]. In a number of clinical cases, it is necessary to consider so-called social factors, such as the patient's refusal of prolonged conservative treatment and the need to restore limb function in a short timeframe, as well as the age of the child [14, 17, 26].

If there are indications for surgery and the patient refuses inpatient treatment, the reason for refusal must be documented in the medical records with the personal signature of the patient or their legal guardians (in case of legally established incapacity of the patient).

3.2.1. Intramedullary osteosynthesis

Comments: When performing intramedullary osteosynthesis of the humeral shaft, the following implants are used: humeral intramedullary nail, sterile***; humeral intramedullary nail, non-sterile***; orthopedic bone screw, non-absorbable, sterile***; orthopedic bone screw, non-absorbable, non-sterile***.

Intramedullary osteosynthesis is indicated for most humeral shaft fractures. It allows for the restoration of the axis and length of the injured limb, as well as the elimination of rotational displacements in the fracture zone without exposing the injury site. This method is characterized by low invasiveness and ensures the preservation of a sufficient level of fixation stability [15, 16, 112, 118, 127, 130, 137]. To reduce the risk of complications, preoperative planning is essential, including identifying the specific fracture architectonics, measuring the diameter and length of the medullary canal, selecting an implant of appropriate design, length, and diameter, and strictly following the installation technique recommended by the manufacturers [63]. There are antegrade and retrograde methods for inserting the intramedullary nail. Antegrade intramedullary osteosynthesis is more widespread because it is technically simpler and has a lower complication rate [9].

Literature analysis has shown that in the treatment of patients with humeral shaft fractures, intramedullary osteosynthesis has certain specific features. Thus, during antegrade insertion of the intramedullary nail (humeral intramedullary nail, sterile***; humeral intramedullary nail, non-sterile***), damage to the cartilage of the humeral head, damage to the tendon of the long head of the biceps brachii, and trauma to the structures of the rotator cuff of the shoulder are possible, especially during reaming of the medullary canal [38]. To minimize these complications, many authors recommend that during the opening and reaming of the medullary canal, an approach should be made with exposure of the rotator cuff and splitting of its fibers under visual control [17, 26]. A frequent complication of antegrade intramedullary osteosynthesis of the humerus is shoulder impingement, manifested by chronic pain and decreased shoulder joint function. It is observed quite frequently: from 5.7% of cases [9] to 16–37% of observations [64, 111]. During closed reduction of bone fragments by traction or due to interposition between fragments, iatrogenic injury to the radial nerve is possible. To prevent this complication, a number of authors even recommend an additional incision in the fracture zone [17, 112]. During proximal locking, there is a risk of injury to the axillary nerve [18, 96]. In such cases, authors also insist on using an extended anterolateral approach to visualize this nerve. During distal locking, there is a noted risk of injury to the brachial artery and radial nerve. To minimize the risk of these complications, an approach of up to 5 cm in length with muscle splitting in the locking zone can be performed, which, however, reduces the value of the method as a minimally invasive surgery [26, 38]. In addition, it is preferable to choose an implant model that allows distal locking in the sagittal plane, in the anteroposterior direction, which also reduces the risk of radial nerve injury during locking.

Retrograde intramedullary osteosynthesis of the humerus is more technically complex, has a number of drawbacks, and is therefore used significantly less frequently than antegrade osteosynthesis. [9, 17]. The disadvantages of retrograde intramedullary osteosynthesis of the humerus include the need to position the patient prone or in the lateral decubitus position, significant damage to the elbow joint capsule, and the risk of iatrogenic condylar and supracondylar fractures when introducing a rigid nail with a breach of surgical technique [38, 119].

It should also be noted that intramedullary osteosynthesis often fails to achieve sufficient rotational stability and interfragmentary compression in transverse and short oblique fractures (AO type A fractures), especially those localized in the upper and lower thirds of the shaft. This can result in the formation of nonunion, sometimes requiring repeated surgical interventions using bone grafting and additional metal hardware. The frequency of such complications reaches 10% [9, 63].

For fractures of the upper third of the humeral shaft, as well as combinations of shaft and proximal humeral fractures, the use of a humeral intramedullary nail, sterile***, or a humeral intramedullary nail, non-sterile*** with the capability of proximal locking in various planes is indicated [26].

In children, it is permissible to use elastic intramedullary nails (TEN) (intramedullary nails and rods: flexible intramedullary nail) passing through the growth plate with subsequent removal after 3–6 months; Kirschner wires can also be used to stabilize fragments.

3.2.2 Plate Osteosynthesis

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

Traditional plate osteosynthesis (bone fixation plate with screws, non-absorbable, sterile***; bone fixation plate with screws, non-absorbable, non-sterile***) with exposure of the fracture site in cases of fresh trauma is rarely used and is indicated for simple shaft fractures. At the same time, it is desirable to ensure interfragmentary compression by inserting a lag screw (orthopedic bone screw, non-absorbable, sterile***; orthopedic bone screw, non-absorbable, non-sterile***) or by eccentric screw insertion into the combination holes of the plate [14, 51].

Traditional plate osteosynthesis for fracture localization in the lower and middle thirds of the diaphysis can be performed via posterior, lateral, and anterior approaches [14, 17, 26, 57]. The posterior approach, with plate positioning on the posterior surface of the humerus, in most cases requires isolation and mobilization of the radial nerve, which crosses the posterior surface of the humeral diaphysis, running in its spiral groove at an average distance of 20.7±1.2 cm proximal to the medial epicondyle and 14.2±0.6 cm proximal to the lateral epicondyle of the humerus. When performing the posterior approach for humeral osteosynthesis, about 15 cm of its diaphysis is available for visualization without retraction of the radial nerve [40]. This fact makes it possible to perform osteosynthesis via the posterior approach without isolating the radial nerve only in very low simple fractures that do not require the placement of a long plate.

Posterior surgical approach is difficult to implement in polytrauma since it requires the patient to be positioned prone or in the lateral decubitus position, which is undesirable in patients with chest injuries and associated pelvic and spinal trauma [57]. Anterior and lateral approaches allow the surgery to be performed with the patient in the supine position, which reduces the risk of pulmonary complications and enables simultaneous procedures. In this case, the plate can be placed on the anteromedial or anterolateral surface of the bone. The anterior approach, performed along the midline of the arm in its lower and middle thirds, does not require isolation of the radial nerve, but requires control and visualization of the musculocutaneous nerve running along the anterior surface of the brachialis muscle in order to preserve it. When using the anterior approach, one should also avoid placing retractors (such as Hohmann retractors) and bone holding forceps along the lateral surface of the humerus in the lower third to prevent injury to the radial nerve. When using the lateral surgical approach in the middle and lower thirds of the arm, isolation and mobilization of the radial nerve are also indicated; as it exits the posterior muscular compartment, it pierces the lateral intermuscular septum at the level of the middle third of the arm and runs further between the brachialis and brachioradialis muscles. The lateral surgical approach should be used in most cases when exploration of the radial nerve is necessary [108].

The anterolateral approach is used for humeral shaft fractures in the upper third and when shaft fractures are combined with proximal humeral fractures [57].

In plate osteosynthesis, fixation is possible using either large-fragment plates with 4.5 mm cortical screws and 5.0 mm locking screws, or sufficiently long small-fragment plates with 3.5 mm cortical and locking screws [39, 57, 61, 78]. In cases of poor bone quality (osteoporosis), it is recommended to use sufficiently long large-fragment plates fixed with bicortical locked screws [48, 128].

For the majority of humeral shaft fractures, plate osteosynthesis can be performed using minimally invasive techniques. When fractures are localized in the middle and lower thirds of the diaphysis, the surgery is performed via two midline mini-approaches on the anterior surface of the arm, positioning a narrow straight plate along the anteromedial or anterolateral surfaces of the diaphysis [8, 69, 70, 100, 120, 131]. If the fracture is localized in the upper third of the diaphysis, or if a shaft fracture is combined with a proximal humeral fracture, minimally invasive plate osteosynthesis using proximal transdeltoid and distal anterior mini-approaches is recommended; in this case, to reduce the risk of injury to the long head of the biceps brachii muscle, the plate should be pre-contoured in a spiral shape, passed subperiosteally beneath the axillary nerve, and its upper end positioned on the lateral surface of the greater tubercle of the humerus, with the diaphyseal part placed on the anterolateral surface of the humerus [33, 129].

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

3.2.3 External Fixation Device

Comments. External fixation as a method of definitive osteosynthesis for humeral shaft fractures is rarely used due to specific complications and limitations (pin-site infections, difficulties in rehabilitation treatment, patient inconvenience). As a rule, external fixation is used as a method of provisional osteosynthesis in cases of open fractures and polytrauma. Subsequently, after wound healing and stabilization of the patient's general condition, conversion to internal fixation is performed [123, 138].

When installing an external fixator, the topography of vessels and nerves should be taken into account, and fixing elements (pins and/or Kirschner wires) should be inserted considering their skin projection: the axillary nerve in the proximal arm, and the radial nerve and brachial artery in the middle and lower thirds [14, 17, 113, 124, 125, 134, 138].

3.2.4 Surgical treatment tactics for humeral shaft fracture complicated by radial nerve injury

According to modern literature, the incidence of post-traumatic radial nerve neuropathy ranges from 3.1 to 18.8% of cases [5, 46, 90, 115]. Post-traumatic radial nerve neuropathy can be primary, occurring directly at the time of injury, or secondary (iatrogenic), developing after certain therapeutic manipulations with bone fragments or after surgical interventions. The incidence of iatrogenic radial nerve injuries in the treatment of patients with humeral shaft fractures ranges from 4 to 16% [67, 102, 116]. Furthermore, the highest incidence of these complications is noted with traditional plate osteosynthesis (up to 31.3% according to An Z., 2010) [5]. The high incidence of radial nerve neuropathy following humeral shaft fractures is due to the specific features of its topography [67, 122]. It should be noted that radial nerve neuropathy occurs predominantly in fractures of the lower and middle thirds of the humeral shaft [22, 77, 82, 90, 115]. The highest risk of such a complication is observed in transverse [82] and spiral [22, 109] fracture patterns.

Types of radial nerve injuries vary. Most commonly, compression of its trunk occurs in the area of the lateral intermuscular septum of the arm; direct entrapment of the nerve between bone fragments is less common. Nerve rupture is more frequently seen in open fractures and high-energy trauma. Ingrowth of the radial nerve into the callus, compression by scar tissue, as well as impingement of the nerve by implants, are the cause of secondary neuropathy [22].

Comments. In primary neuropathy associated with closed humeral shaft fractures with satisfactory alignment of bone fragments, conservative therapy is possible with a high probability of nerve function recovery within 3–4 months [17, 26, 90].

In secondary (iatrogenic) radial nerve neuropathy, the majority of authors recommend conservative treatment provided there is absolute certainty that the nerve was not directly injured during surgery.

When choosing a conservative treatment method for both primary and iatrogenic radial nerve neuropathy, it is necessary to rule out disruption of the anatomical continuity of the radial nerve, as well as its impingement by bone fragments and/or implants [17, 26, 90].

Delayed radial nerve revision surgeries are performed in cases where there is no positive dynamics with conservative therapy over 4–6 months. [90, 106, 114].

The nature of the radial nerve injury and its relationship with implants and bone fragments can be determined using ultrasound diagnostics [115].

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 performed for any injuries involving compromised integrity of the skin and mucous membranes. Emergency tetanus prophylaxis is carried out up to the 20th calendar day from the moment of injury [139]. The administration of medications for emergency tetanus immunoprophylaxis is carried out differentially depending on the presence of documented confirmation of preventive vaccination or immunological monitoring data on anti-tetanus immunity titers, as well as taking into account the nature of the injuries.

Emergency tetanus immunoprophylaxis is carried out in the form of:

• passive immunization or seroprophylaxis with human tetanus immunoglobulin** (HTIG), or tetanus antitoxin (TAT) if HTIG is unavailable;

• active-passive prophylaxis, consisting of simultaneous administration of human tetanus immunoglobulin** (or TAT if unavailable) and tetanus toxoid** (TT) into different body sites;

• emergency revaccination with tetanus toxoid** (or reduced-antigen diphtheria-tetanus toxoid** - Td) to stimulate immunity in previously vaccinated individuals [68, 139].

4. Medical Rehabilitation and Sanatorium-Resort Treatment

• Postoperative mobilization of the patient and restoration of range of motion in the shoulder and elbow joints should be initiated as early as possible. Patient activation is recommended within 24 hours after surgery [14, 79].

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

Comments: Rehabilitation begins immediately after fracture fixation with a plaster cast. Each period addresses specific goals and objectives determined by the PRM (Physical and Rehabilitation Medicine) physician / exercise therapy doctor [37, 121].

Comments: The rehabilitation program is prescribed by the PRM/exercise therapy physician and performed independently at home. The objective of this period is to reduce pain and tissue edema by elevating the arm, improving blood circulation during exercises, and preventing joint stiffness. Exercises are performed 3–4 times a day with multiple repetitions of each movement. Special exercises for the injured arm alternate with breathing exercises and exercises for the healthy limbs.

Comments: The rehabilitation program for the first two weeks after cast removal is prescribed by a PM&R / exercise therapy physician after examining the patient to increase mobility in the elbow and shoulder joints and normalize muscle tone. Exercises are performed with minimal load, at a slow pace, within a pain-free range of motion. Each exercise is repeated up to 10 times, 3-4 times a day.

Comments: The program is developed after a follow-up examination by a PM&R / exercise therapy physician. The objectives of this period are to restore the function of the arm joints, muscle strength, and movement coordination during self-care and professional activities. A distinctive feature of this stage is the gradual increase in the load and intensity of the performed exercises, as well as the expansion of daily activities that contribute to the restoration of arm strength and endurance.

Comments: The objectives of rehabilitation in the early postoperative period are the prevention of general postoperative cardiovascular and respiratory complications, reduction of soft tissue edema, and creation of optimal anatomical and physiological conditions for the healing of tissues traumatized during surgery.

Comments: A distinctive feature of this stage is the dosed, gradual increase in joint range of motion and soft tissue stretching without increasing edema and pain. Physical therapy aimed at pain relief and edema reduction plays a major role.

Comments: The aim of this stage is to restore mobility of the elbow and shoulder joints, muscle strength, hand movement coordination, self-care capacity, and working ability.

Comments: A feature of this period is the gradual increase in the load and intensity of performed exercises, with a gradual transition from passive to active movements to restore muscle strength and endurance. The rehabilitation program is determined individually depending on the patient's general condition and the degree of bone healing in the fracture area. Until callus formation, dynamic self-assisted exercises in alleviated conditions, positioning therapy, isometric exercises, exercises with light objects, and passive mechanotherapy for the elbow and/or shoulder joint are prescribed depending on the degree of stiffness. In the absence of signs of inflammation in the postoperative suture area, physical exercises in water are prescribed.

Following control radiography confirming callus formation, the rehabilitation program includes dynamic exercises with weights and resistance, static exercises, passive mechanotherapy for the elbow joint, manual and/or underwater massage of the arm and forearm muscles, physical exercises in water, and training of movement coordination and self-care skills. The issue of axial loading on the upper extremity, for example, when walking with crutches, skiing, doing push-ups, or lifting heavy objects, is decided individually, but no earlier than 6 weeks after surgery. The program for this stage, in cases of fracture fixation with external fixation devices, begins after the device is removed.

In the presence of inflammation in the postoperative scar area, laser therapy and ultraviolet irradiation (UVI) are prescribed.

Comments: The primary tasks of rehabilitation in nerve injuries are to create optimal conditions for its regeneration, maintain the function of denervated muscles, and subsequently, during recovery, to stimulate weakened muscles and restore movements.

Rehabilitation is prolonged, lasting about 1–2 months, and consists of physical therapy procedures: muscle and nerve electrical stimulation, ultrasound therapy; manual, point, and vibratory massage; therapeutic exercise with passive mobilization of the fingers and hand, active assisted movements, corrective positioning, self-help exercises, passive mechanotherapy, and biofeedback training. It is very important to position the limb correctly and ensure rest using splints and fixation orthoses.

If conservative therapy is insufficiently effective 4–6 months from the date of injury, surgical treatment is resorted to. Postoperative rehabilitation is carried out in an inpatient setting; programs are selected individually depending on the patient's condition and the severity of the neurological deficit.

5. Prevention and Dispensary Observation

Prevention of humeral shaft fractures consists in compliance by citizens with social safety rules when performing household chores, being in vehicle traffic zones, walking on poor-quality pavement, and during icy conditions.

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

Comments: After discharge from the hospital, the patient should be referred to a trauma center or outpatient trauma department with an indication of the treatment performed and detailed recommendations for the continuation of treatment and rehabilitation. This will ensure continuity between the inpatient and outpatient stages of treatment.

Follow-up examinations with radiography (radiography of the humerus) and assessment of functional recovery dynamics are performed at 6 weeks postoperatively (assessment of fracture union degree and feasibility of full limb loading), 12 weeks postoperatively (assessment of fracture union degree and feasibility of limb loading), 24 weeks postoperatively (assessment of union degree, assessment of functional recovery dynamics), 1 year postoperatively (assessment of the functional outcome of treatment and deciding on the need and timing for implant removal). In children, the timing of implant removal is considered depending on whether they cross the growth plate or not, as well as age; after 15 years, the principles are the same as in adults.

6. Organization of Medical Care

Clinical application of the guidelines: Traumatology and Orthopedics, Anesthesiology and Critical Care Medicine, Medical Rehabilitation, Pediatric Surgery, Healthcare Organization and Public Health.

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

Indications for planned hospitalization:

unsatisfactory result of conservative treatment – absence of signs of humeral shaft fracture union after conservative treatment or osteosynthesis surgery within 2.5–3.5 months after injury or surgery [14, 17, 26, 142].

Indications for emergency hospitalization:

Patients with suspected fracture or confirmed diagnosis of humerus fracture are subject to referral to a hospital to resolve the issue of the need for emergency hospitalization. Indications for emergency hospitalization are:

• fracture with significant displacement, i.e., shortening of the arm by more than 3 cm, rotational displacement by more than 30°, and angular displacement by more than 20°;

• fragmentary fracture of the humerus;

• pathological fracture of the humerus;

• bilateral humeral fractures;

• combination of fractures with traumatic brachial plexus neuritis;

• transverse fracture of the humeral shaft in the lower and middle thirds with fragment displacement;

• long oblique fractures of the upper third of the humeral shaft with fragment displacement;

• open humeral shaft fracture;

• gunshot fracture of the humerus;

• humeral shaft fracture accompanied by injury to major vessels and nerves;

• humeral shaft fracture as part of polytrauma;

• ipsilateral fractures of the humeral shaft and forearm bones;

• radial nerve neuropathy that developed after manipulation of bone fragments [14, 17, 26, 142]..

Indications for emergency hospitalization for a humeral shaft fracture are determined based on:

1. the presence of complaints characteristic of a humeral shaft fracture in the patient;

2. the presence of characteristic clinical signs of a humeral shaft fracture;

3. the presence of radiological signs of a humeral shaft fracture in the patient.

Indications for patient discharge from the hospital:

1. Internal fixation of the fracture with hardware, an implant, or stabilization with an external fixation device has been performed, or adequate plaster immobilization has been carried out for conservative treatment.

2. The first stage of rehabilitation has been completed.

3. There is no acute infectious process.

Refusal by the patient or their guardians (in cases of legally established patient incompetence) to continue inpatient treatment (the reason for refusal must be documented in medical records with the personal signature of the patient or their guardians).

7. Additional Information

To assess treatment outcomes in patients with fractures at the shoulder girdle and arm level, questionnaires have been developed to evaluate the functional result of treatment.

1. Disabilities of the Arm, Shoulder, and Hand questionnaire (Disabilities of the Arm, Shoulder, and Hand, Engl. – DASH) was developed jointly by the American Academy of Orthopaedic Surgeons (American Academy of Orthopaedic Surgeons), the Council of Musculoskeletal Specialty Societies (Council of Musculoskeletal Specialty Societies), and the Institute for Work and Health of Canada (Institute for Work and Health). It belongs to patient-reported outcome measures (patient-reported outcome measures) and was introduced in 1996 for the standardized assessment of the impact of various musculoskeletal injuries and diseases on upper extremity function [56]. DASH is a 30-item questionnaire with response options presented as a 5-point Likert scale. Scores range from 0 (no functional limitations) to 100 (most severe functional limitations). The questionnaire is intended for patients with any musculoskeletal disorders of the upper extremities [104]. DASH has two optional modules (four items each) designed for athletes, musicians, and workers whose activities require specific physical conditioning, where functional limitations may arise only under high loads beyond the scope of the 30 DASH items. Approved translation versions of DASH in 56 languages and dialects, including Russian, are available on the website of the Institute for Work and Health of Canada, which holds the copyright to the questionnaire (https://dash.iwh.on.ca/available-translations).

2. The Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH) is a shortened 11-question version of the DASH questionnaire with the same response options [7, 45]. Like DASH, it is intended for patients to self-assess the degree of upper extremity functional impairment in various diseases and injuries. QuickDASH also has two optional modules (four items each) designed for athletes, musicians, and workers whose activities require specific physical conditioning, where functional limitations may arise only under high loads beyond the scope of the 11 QuickDASH items. Additional modules are evaluated separately. In a number of studies, comparison of the DASH and QuickDASH questionnaires showed that both instruments have approximately equal sensitivity, specificity [1, 32, 34, 72, 101], and minimal clinically important difference in values (12–14 points for DASH and 12–15 points for QuickDASH) [36]. In a systematic review of 23 self-assessment instruments for patients with various upper extremity pathologies, the QuickDASH questionnaire demonstrated the highest content and construct validity, reliability, and responsiveness [2]. There are reports of the successful use of QuickDASH in children aged 8–18 years [52, 81]. Approved translation versions of QuickDASH in 56 languages and dialects, including Russian, are available on the website of the Institute for Work and Health of Canada, which holds the copyright (https://dash.iwh.on.ca/available-translations).

   The Russian translation of the QuickDASH in its original version is provided in Appendix G1.

Criteria for Evaluating the Quality of Medical Care

References

Appendix A1. Working Group Composition

1. Belenky I.G., MD, Associate Professor, Saint Petersburg Research Institute of Emergency Medicine named after I.I. Dzhanelidze, Saint Petersburg, member of ATOR.

2. Bozhkova S.A., Dr. Sci. (Med.), National Medical Research Center of Traumatology and Orthopedics named after R.R. Vreden of the Ministry of Health of the Russian Federation, St. Petersburg, member of ATOR.

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

4. Kleymenova E.B., MD, Professor, Priorov National Medical Research Center of Traumatology and Orthopedics of the Ministry of Health of the Russian Federation, Moscow.

5. Mayorov B.A., Candidate of Medical Sciences, Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine, St. Petersburg State University named after Academician I.P. Pavlov, St. Petersburg, member of ATOR.

6. Nazarenko A.G., MD, DSc, Professor of the RAS, National Medical Research Center of Traumatology and Orthopedics named after N.N. Priorov of the Russian Ministry of Health, Moscow, Vice President of ATOR.

7. Otdelenov V.A., PhD, Priorov National Medical Research Center of Traumatology and Orthopedics of the Ministry of Health of the Russian Federation, Moscow.

8. Proshchenko Ya.N., MD, Turner National Medical Research Center for Children's Orthopedics and Trauma of the Russian Ministry of Health, St. Petersburg.

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

Conflict of interest.

The working group responsible for drafting the clinical guidelines for the treatment of humeral shaft fractures has no conflicts of interest.

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience for these clinical guidelines:

1. Trauma and orthopedic surgeons

2. Surgeons

3. General practitioners

4. Medical rehabilitation physicians

5. Healthcare organization and public health specialists.

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

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

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

Systematic search and selection of publications on clinical trials:

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.

The level of reliability of evidence contained in the publications was assessed in accordance with Tables 1 and 2. Publications with the highest level of evidence reliability were selected.

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

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

The table presents analgesic drugs and their dosing regimens in accordance with the Clinical Guidelines for Pain Management in Acute Musculoskeletal Injury [55].

Appendix A3.2. Guidelines for pain management in musculoskeletal trauma without surgery (closed fractures, superficial wounds, etc.) in adults

The table presents analgesic drugs and their dosing regimens in accordance with the Clinical Guidelines for Pain Management in Acute Musculoskeletal Injury [55].

Appendix A3.3 Analgesic dosage regimen for children

¹Morphine** is preferred for children under 12 years of age when opioid analgesics are indicated, as the use of tramadol** is associated with a higher risk of adverse reactions [160, 161].

²Not recommended for use in children, as its metabolite accumulates in the body and provokes seizures upon repeated administration [162].

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

It should be noted that spinal or epidural anesthesia can be performed only 12 hours after the administration of a low-molecular-weight heparin dose and no earlier than 4–6 hours after the administration of unfractionated heparin (meanwhile, aPTT or ACT values must be within the normal range) [163, 164].

Appendix A3.5 Bleeding risk factors in children aged 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 g/dL, or platelets < 50,000/μL.

Appendix A3.6 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.

• Central venous access device is defined as a non-tunneled catheter, tunneled catheter, or central venous catheter.

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

• Major surgical interventions include operations lasting more than 45 minutes.

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

• Thrombophilic conditions include antithrombin defects, 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 Physician's action algorithm in suspected humeral shaft fracture

Appendix B2 Physician's action algorithm in assessing cardiovascular risk of surgery

CVD – cardiovascular disease 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 – revised cardiac risk index (see Appendix G2);

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

*– regional vascular center or specialized cardiology department.

Appendix C. Patient Information

Humeral shaft fractures are injuries requiring specialized treatment in a trauma center or traumatology department. Conservative treatment of such injuries is only possible for fractures without fragment displacement. This type of treatment involves prolonged immobilization with a plaster cast or its alternatives. Its main drawback is the deterioration of quality of life and the need for prolonged rehabilitation, as immobilization may result in contracture of the shoulder and elbow joints. Surgical treatment is indicated for all fractures with fragment displacement. Various plate configurations, intramedullary nails, and external fixation devices in various configurations can be used to treat humeral shaft fractures. Treatment can be single-stage (for isolated closed fractures and satisfactory soft tissue condition) and two-stage, where the fracture is first temporarily fixed with an external fixator followed by conversion to internal fixation (in multiple and polytrauma, severe open fractures, and significant soft tissue injury). For these fractures, complete restoration of the injured bone anatomy is not required; restoring the axis, limb length, and eliminating rotational displacement is sufficient. In most cases, minimally invasive osteosynthesis techniques that do not involve opening the fracture site are used for this purpose. In all cases, the goal should be to achieve stable osteosynthesis that does not require additional external immobilization after surgery. This allows for early rehabilitation treatment.

Rehabilitation treatment should begin immediately after surgery. It consists of passive and active movements in the upper extremity joints, physiotherapeutic procedures, and exercises aimed at normalizing the trophic state of the injured soft tissues and bone. The timing of limb load-bearing may vary depending on the fracture pattern and fixation method. As a rule, following intramedullary osteosynthesis of extra-articular fractures, functional loading of the limb is permitted in the first days post-surgery. Following osteosynthesis of similar fractures with plates, the timing of axial loading depends on the complexity of the fracture, though functional joint movements in the injured upper extremity are possible in the first days after surgery.

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

Appendix G1. QuickDASH upper extremity disability questionnaire

Russian title: The shortened disabilities of the arm, shoulder and hand questionnaire.

Original title: The shortened disabilities of the arm, shoulder and hand questionnaire (Quick DASH)

Source: Quick DASH Outcome Measures: Russian translation. Institute for Work & Health, 2006. https: //dash.iwh.on.ca /available-translations

Type: questionnaire

Purpose: assessment of the impact of musculoskeletal injuries and diseases on upper extremity function.

Content:

INSTRUCTIONS: This questionnaire asks about your symptoms as well as your ability to perform certain activities. Please answer each question based on your condition over the past week by circling the appropriate number. If you did not have the opportunity to perform a specific activity last week, please choose the most appropriate response. It does not matter which hand you use to perform the action; please answer based on your ability, regardless of how you independently perform the task.

QuickDASH disability/symptom score = where n is the number of completed responses.

The QuickDASH score cannot be calculated if more than 1 item is missed.

OPTIONAL MODULE SCALING. All 4 questions must be answered. Simply add the assigned values for each response and divide by 4 (number of items); subtract 1 and multiply by 25.

Appendix G2. Caprini Risk Assessment Model for Venous Thromboembolism (Caprini J.)

Russian title: Caprini risk assessment model for venous thromboembolism.

Original title: Caprini Score for Venous Thromboembolism

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

Type: scale

Purpose: assessment of venous thromboembolism risk

Content:

1 point

Age 41-60 years

Lower extremity edema

Varicose veins

Body mass index over 25 kg/m2

Minor surgery

Sepsis (< 1 month)

Severe pulmonary disease (including pneumonia < 1 month)

Oral contraceptive use, hormone replacement therapy

Pregnancy and postpartum period (< 1 month)

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

Premature birth with preeclampsia or intrauterine growth restriction

Acute myocardial infarction

Chronic heart failure (< 1 month)

Bed rest in a non-surgical patient

History of inflammatory bowel disease

History of major surgery (< 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 (< 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.

Appendix G3 Revised Cardiac Risk Index (rRCRI)

Russian title: Reconstructed Revised Cardiac Risk Index for noncardiac surgical procedures

Original title: Reconstructed Revised Cardiac Risk Index (rRCRI)

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

Type: scale

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

Content:

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

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

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

4. TIA/Stroke – 1 point.

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

Scoring:

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

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

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

Notes:

The RCRI index was developed in 1977 [44] to predict the risk of perioperative cardiac complications in noncardiac surgery. It was validated in the Lee study [66], and in 2013 [25] it was revised and re-validated based on clinical risk factors (the criterion "serum creatinine level >176.8 µmol/L" was replaced by "creatinine clearance <30 mL/min"; the clinical criterion "insulin-requiring diabetes mellitus" was removed), which is why it is called the revised index. It includes 5 parameters, each assigned 1 point. This exact version of the index is recommended by the Russian Society of Cardiology [135].