Proximal humerus fractures: clinical guidelines

List of Abbreviations

EFA – external fixation apparatus

AO – Association for Osteosynthesis

VTE – venous thromboembolism

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

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

PH – proximal humerus

TAT – tetanus antitoxin

HTIG – human tetanus immunoglobulin

SWD – surgical wound debridement

SCT – spiral computed tomography

TIA – transient ischemic attack

RF – risk factors

PRM – physical and rehabilitation medicine

FS – functional status

TENS – transcutaneous electrical nerve stimulation

Surgical antibiotic prophylaxis

LCP – locking compression plate

ORIF – open reduction internal fixation

TEN – titanium elastic nail for children

KW – Kirschner wire

Terms and Definitions

Internal fixation device — an orthopedic implant placed during surgery that connects bone fragments in the treatment of fractures, deformities, or pseudarthrosis.

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 the surrounding soft tissues.

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

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.

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

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

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

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

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

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

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

Rotator cuff – a functional group of four muscles and their tendons located deep around the shoulder joint, serving to stabilize and rotate the humerus. The rotator cuff includes: the supraspinatus, infraspinatus, teres minor, and subscapularis muscles.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Proximal humerus fractures are a non-classification concept uniting extra-articular and intra-articular fractures of the upper third of the humerus. These fractures represent a disruption of the integrity of the humerus in the proximal metaepiphysis area due to trauma. These injuries can be extra-articular or intra-articular; in children, a special type of fracture is epiphyseolysis and osteoepiphyseolysis. According to the number of fragments, PH fractures are divided into simple and comminuted.

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

PH fractures occur as a result of a high-intensity external traumatic agent. Direct and indirect trauma mechanisms are distinguished. In the direct trauma mechanism, force is applied directly to the fracture site. The indirect trauma mechanism is characterized by the fact that the injuring force is applied at a distance from the fracture site. According to the energy of injury, high-energy and low-energy fractures are distinguished. The former are usually the result of direct trauma and are accompanied by significant damage to surrounding soft tissues. Low-energy fractures have an indirect trauma mechanism and occur in patients with reduced bone mineral density. In most cases, PH fractures are the consequence of low-energy trauma and occur due to the indirect action of the injuring agent [1, 2]. The most frequent causes are falls from standing height onto an abducted upper extremity. High-energy PH injuries occur significantly less often and are often characterized by a complex fracture pattern with damage to the articular surface of the humerus. In newborns, the cause of fracture–epiphyseolysis of the proximal end of the humerus is obstetric delivery and is termed obstetric epiphyseolysis of the proximal end of the humerus.

1.3 Epidemiology of the Disease or Condition

PH fractures rank third (4-10% of all fractures) in frequency of occurrence after proximal femur fractures and distal radius fractures. Women and elderly people are most susceptible to this injury – the mean age of victims is 71 years [1, 2, 3, 4]. The incidence of PH fractures ranges from 31 to 250 cases per 100,000 population per year, with an increase noted due to the growing proportion of the elderly population [1].

1.4 Features of Coding the Disease or Condition

ICD-10:

S42.2 – Fracture of upper end of humerus

S42.7 – Multiple fractures of clavicle, scapula and humerus

S42.8 – Fracture of other parts of shoulder girdle and arm

S42.9 – Fracture of shoulder girdle and arm, part unspecified

S43.0 – Dislocation of shoulder joint

S43.4 –Sprain and strain of joint capsule and ligaments of shoulder joint

S43.5 – Sprain and strain of acromioclavicular joint capsule and ligaments

S46.0 – Injury of muscle and tendon of rotator cuff of shoulder

T92.1 – Sequelae of fracture of upper limb, level unspecified

1.5 Classification of the disease or condition

To accurately determine the anatomical location of a fracture, its center must be determined. 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 [5].

All metaepiphyseal fractures are divided into extra-articular and intra-articular. Intra-articular fractures, in turn, are subdivided into partial, in which part of the articular surface remains intact and retains connection with the undamaged diaphysis, and complete, in which the entire cross-section of the metaphyseal bone is damaged; in the presence of a growth plate in children, the fracture passes through the growth plate and is called epiphyseolysis.

Diagnosis coding begins with determining the anatomical localization of the fracture: bone and segment. According to the AO classification, the humerus has the number 1. A PH fracture is coded as 11. Then, the morphological characteristics of the fracture are determined. This consists in determining the type, group, and subgroup of the fracture. All fractures are subdivided into 3 types: A, B, and C.

11-A – extra-articular two-fragment PH fracture

11-A1 – fracture of the humeral tuberosity (greater or lesser)

11-A2 – fracture of the surgical neck of the humerus

11-A3 – vertical fracture

11-B – extra-articular three-fragment PH fracture with fracture of the surgical neck

11-B1 – fracture of the surgical neck combined with a tuberosity fracture (greater or lesser)

11-C – intra-articular or four-fragment PH fracture

11-C1 – fracture of the anatomical neck of the PH

11-C3 – fracture of the anatomical neck combined with a complex fracture of the metaepiphyseal part or extending into the diaphysis

Neer's four-fragment classification of PH fractures implies the isolation of 4 fragments in the PH: the humeral diaphysis, greater tuberosity, lesser tuberosity, and the articular surface of the humeral head. Category division is based on the number of displaced PH fragments with additional categories for fracture-dislocations and intra-articular fractures. Displacement is defined as fragment separation of more than 1 cm or rotational displacement of fragments relative to each other of more than 45 degrees.

Neer classification:

One-fragment fracture – none of the fragments meets the displacement criteria. In this case, regardless of the number or location of the PH fracture lines, the fracture is classified as a one-fragment fracture.

Two-fragment fracture – one of the fragments is displaced; this may be the greater tuberosity, lesser tuberosity, or fragment with the articular surface with the fracture line at the level of the surgical or anatomical neck.

Three-fragment fracture – fracture of one of the tuberosities combined with a fracture of the surgical neck of the humerus with rotational displacement of the fragments.

Four-part fracture – displaced fractures with the formation of 4 fragments (both tuberosities, the articular surface, and the diaphyseal shaft). Usually, the articular surface of the humeral head is displaced laterally and dislocated. This injury is accompanied by a high risk of avascular necrosis.

Four-part fracture with valgus impaction – a fracture characterized by the fact that the humeral head is impacted between the tuberosities and assumes a valgus position. This category was added by Neer due to the fact that in this type of fracture, the articular surface of the proximal humerus maintains congruence with the glenoid cavity of the scapula, which determines a prognosis and treatment different from those of a classic four-part fracture.

Fracture-dislocations and fractures of the articular surface of the humeral head – this type of injury is classified into a separate category due to the fact that it is characterized by a high risk of avascular necrosis and heterotopic ossification. Articular surface fractures are subdivided into split fractures and fractures with articular surface impression [6].

For open fractures of the proximal humerus, the classification by R.B. Gustilo, J.T. Anderson (1976) [7] as modified by R.B. Gustilo, R.M. Mendoza, and D.N. Williams (1984) [8] is used:

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

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

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

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

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

In children, the general Salter-Harris classification of fractures involving the growth plate is used.

1.6 Clinical presentation of the disease or condition

Complaints: pain in the shoulder and/or shoulder joint area, impaired function of the upper extremity, deformation in the upper third of the arm or shoulder joint, pain in the wound area (in open fractures).

Anamnesis: a history of trauma, the patient describes a characteristic mechanism of injury. Most often, the mechanism of injury is indirect – a fall from standing height onto an abducted arm. In rare cases, such an injury may occur in patients with seizure disorders. In high-energy trauma (in case of a traffic accident or a fall from a height), injuries are characterized by greater severity and may be combined with injuries to other body segments or areas; therefore, it is necessary to carefully collect the patient's complaints and perform a physical examination.

Objective status: swelling of the shoulder joint area, smoothing of contours, limitation of active and passive movements due to severe pain syndrome, forced position of the limb; in fracture-dislocations of the proximal humerus, changes in the contours of the shoulder joint and soft tissue depression in the subacromial space are possible; palpation reveals marked tenderness in the upper third of the arm, and crepitus of bone fragments may be present during passive movements.

2. Diagnostics, medical indications and contraindications for diagnostic methods

Criteria for establishing the diagnosis/condition:

• anamnestic data: history of a characteristic upper extremity trauma mechanism (fall, traffic accident, etc.)

• physical examination findings: impaired function of the injured segment, local swelling and tenderness in the trauma region (pain exacerbated by axial loading), presence of abnormal mobility and/or fragment crepitus

• Instrumental examination data: radiographic signs of fracture based on radiography in 2 projections. Additional CT scanning may be performed as prescribed by the on-duty or attending trauma surgeon/orthopedic 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 complaints described in Section 1.6 "Clinical Presentation"

2.2 Physical Examination

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

• The assessment of the following parameters is recommended to be carried out no later than 1 hour after admission to the hospital, with mandatory recording of the results in the medical history:

- Assessment of somatic status;

- Visual and palpation assessment of local status [9, 19, 129].

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

- Blood pressure measurement;

- Body temperature measurement;

- Assessment of the risk of venous thromboembolic complications [10].

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

• Level of Evidence C (reliability of evidence level – 5).

• Level of Evidence C (reliability of evidence level – 5).

• When making a decision on surgical treatment of a fracture in adult patients with proximal humeral fractures, it is recommended to collect a medical history and perform a physical examination to identify risk factors and cardiovascular diseases [11, 12].

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

Comment: Risk factors for the development of cardiovascular diseases include: arterial hypertension, smoking, dyslipidemia (elevated total cholesterol >4.9 mmol/L and/or LDL cholesterol >3 mmol/L and/or HDL cholesterol <1.0 mmol/L in men, <1.2 mmol/L in women, and/or triglycerides >1.7 mmol/L), diabetes mellitus, family history of cardiovascular disease at a young age (<55 years for men and <65 years for women) [11]. Established cardiovascular disease is understood as: coronary artery disease, cerebrovascular disease, peripheral atherosclerosis, chronic heart failure, pulmonary hypertension, valvular heart disease, cardiomyopathies [12, 13].

• All adult patients referred for elective surgical treatment of a proximal humeral fracture are recommended to undergo an assessment of the risk of perioperative cardiovascular complications, taking into account the type of planned surgical treatment, regardless of the presence of comorbid pathology [11, 14].

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 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 surgeries are associated with an intermediate (moderate) risk of cardiovascular complications (30-day risk of myocardial infarction or cardiovascular death after surgery is 1-5%) [15].

• To assess the risk of perioperative cardiovascular complications in adult patients, it is recommended to use a special algorithm (Appendix G2) [15, 16].

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

• Elective surgical treatment of a proximal humeral fracture is recommended to be performed without additional examination in adult patients in whom the risk of cardiovascular complications is determined to be low. In adult patients with an intermediate or high perioperative risk of cardiovascular complications, an assessment of functional status is recommended [15, 17].

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

2.3 Laboratory Diagnostics

• All patients diagnosed with a proximal humeral fracture are recommended to undergo the following laboratory tests for diagnostic purposes:

- complete blood count (CBC);

- urinalysis;

- general clinical blood chemistry test;

- determination of main ABO blood groups and Rh factor (D antigen);

- hepatitis B surface antigen (HBsAg);

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

- determination of antibodies to Treponema pallidum in the blood,

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

- coagulogram (exploratory hemostasis test);

- determination of the international normalized ratio (INR) [18, 19].

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

• When deciding on surgical treatment of a proximal humeral fracture in adult patients, it is recommended to test the blood level of NT-proBNP in cases of intermediate or high risk of cardiovascular complications and low functional status (see Appendix B2) [11, 13, 15, 20, 21].

QOE 2Level of Evidence A (reliability of evidence level – 2).

2.4 Instrumental Diagnostics

• Patients with a proximal humeral fracture are recommended to undergo radiography of the upper extremity and shoulder joint in two projections (arm and shoulder joint in two projections including the elbow joint) for diagnostic purposes [1, 22, 130].

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

Comments: Performing radiography of the shoulder capturing two joints is necessary to diagnose a proximal humeral fracture (PHF), determine the fracture pattern and the degree of fragment displacement, and rule out injury to the segment at other levels. The radiographic examination must include radiographs in the true anteroposterior view (where the patient is turned 30 degrees toward the injured shoulder), scapular Y-views (with the patient positioned with the injured side against the cassette and back to the beam, with a 30-degree angle between the frontal plane and the beam), and an axial view [1, 15]. After confirming the PHF using diagnostic imaging, the patient should be hospitalized in an inpatient facility if indicated; if there are no indications for hospitalization, the patient may be discharged for outpatient treatment at their place of residence.

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

• Patients with a PHF are recommended to undergo computed tomography of the shoulder joint in the presence of or suspicion of an intra-articular PHF to clarify the diagnosis and the nature of fragment displacement [1, 22, 130].

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

Comments: Spiral CT provides the traumatologist with additional information about the fracture pattern, the degree of fragment displacement, and the severity of articular surface damage, thereby significantly improving the quality of preoperative planning.

• Patients with a PHF are recommended to undergo magnetic resonance imaging of the shoulder joint (single joint) in the presence of or suspicion of brachial plexus injuries (excluding plexopathy) as well as other soft tissue injuries, such as rotator cuff tears [23, 24, 130].

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

• Patients with a PHF are recommended to undergo computed tomography angiography of the upper extremity (shoulder) vessels with intravenous contrast or shoulder arteriography (upper extremity artery angiography) if physical examination following shoulder and shoulder joint radiography suggests vascular injury [23].

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

• Patients with a proximal humeral fracture are recommended to additionally undergo Doppler ultrasound of the upper extremity vessels (arteries and veins) if vascular injury of the upper extremity is suspected [23, 130].

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

• Adult patients with a PHF are recommended to undergo an ECG to rule out acute coronary syndrome, cardiac arrhythmias, and conduction disorders [25].

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

2.5 Other Procedures

- neurosurgeon consultation: in case of nerve injury or suspected nerve injury and concomitant head trauma, for children in a multidisciplinary hospital setting;

- neurologist consultation in children: in case of nerve injury or suspected nerve injury or concomitant head trauma;

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

- pediatric surgeon consultation for children: in case of suspected or objectively diagnosed concomitant abdominal and/or chest trauma;

- vascular surgeon consultation: in case of concomitant vascular injury or suspected vascular injury for a multidisciplinary hospital;

- pediatrician consultation: in the presence of comorbid pediatric conditions (according to the child's medical history);

- therapist consultation: in the presence of comorbid internal medicine conditions (according to medical history) [31, 129].

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

• Before surgical treatment of a PHF, it is recommended to consult a general practitioner/cardiologist or anesthesiologist-resuscitologist to rule out acute or unstable cardiovascular conditions and assess perioperative cardiovascular risk [19, 129].

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

• Before surgical treatment of a PHF, it is recommended to consult a cardiologist for patients with ECG abnormalities and/or elevated NT-proBNP levels if they are determined to be at high perioperative risk and have low functional status [15].

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

• If acute or unstable clinical conditions are identified, it is recommended to postpone elective surgical treatment of a PHF until the patient's cardiac status improves and condition stabilizes; transfer of the patient to a regional vascular center or specialized cardiology department is indicated [15].

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

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

3.1 Conservative Treatment

• Patients with PHFs upon admission to the hospital are recommended the following minimum scope of care in the admission department:

• ensuring thermal comfort for the patient;

• adequate pain management;

• immobilization of the injured upper extremity;

• correction of fluid and electrolyte imbalances [1, 19, 25, 129].

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

Comments: In 84% of cases, patients with PHFs do not require surgical treatment [1, 2, 32].

Comments: In modern scientific literature, authors emphasize the importance of early functional movements in the joints of the injured extremity while ensuring that secondary fragment displacement is absent [31].

When immobilizing with a sling, the upper extremity should be placed in a neutral rotation position, as this position reduces the risk of bone fragment displacement and, consequently, patients demonstrate better functional outcomes [2].

Pain Management

For adequate pain management, patients with a PHF are recommended to receive multimodal analgesia, which may include NSAIDs from group M01A Anti-inflammatory and antirheumatic products, paracetamol**, gabapentinoids, and immediate-release opioids, or monomodal analgesia if multimodal administration is not feasible [33-40].

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

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 to use multimodal analgesia (MMA), which involves the use of multiple analgesic drugs (opioid and non-opioid) from group N02 (Analgesics) with different mechanisms of action, combined with non-pharmacological interventions targeting the peripheral and/or central parts of the nervous system [25]. This combination provides more effective pain relief by enhancing the effects of various drugs, which in most cases leads to a reduced frequency of prescriptions and/or doses of opioid analgesics. Thus, MMA improves the risk profile of each drug while ensuring synergistic pain control through different drug classes. Postoperative MMA may include psychotherapy, physical therapy, NSAIDs, paracetamol**, gabapentinoids, regional anesthesia (single-shot injection or peripheral nerve catheter placement), local injections, and opioids [35, 36].

In modern scientific literature, authors emphasize the use of the lowest effective doses of opioids for the shortest possible time, avoiding extended-release opioids. As an adjuvant during MMA, a single perioperative administration of #dexamethasone** can be used, which provides a significant reduction in pain [39].

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

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

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.

In children with fractures of the proximal humerus, the use of paracetamol** and ibuprofen** is recommended for analgesia [133].

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

In children with severe pain and lack of efficacy from paracetamol** and ibuprofen**, the use of other non-steroidal and narcotic analgesics is recommended if appropriate indications are present and contraindications are absent [133].

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

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

Prevention of venous thromboembolic events

Comments: The incidence of VTE is 0.64% following surgeries for proximal humerus fractures (open reduction and internal fixation or hemiarthroplasty), which makes pharmacological prophylaxis rational for patients at high risk of VTE. 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 and often uncontrolled 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 due to shoulder and forearm fractures, as well as extensive upper extremity soft tissue trauma. The final decision is made by the attending physician, taking into account the extent of the injury, the nature of the planned intervention, and additional patient VTE risk factors. Perioperative prescription of low-molecular-weight heparins (LMWH) for these patients according to the regimens and dosages given in Appendix A 3.4 for 7–10 days (until hospital discharge) or for several days until normal/expected mobility is restored may be possible.

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

Issues regarding VTE prevention in trauma and orthopedic patients are discussed in detail in the 2022 guidelines [44] and the 2023 Russian expert recommendations [45].

Features of thromboprophylaxis in pediatric patients

Hospitalized patients older than 6 months are recommended to undergo bleeding and VTE risk assessment within 24 hours of admission [117] and periodically during their hospital stay [118–120].

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

Comment: Validated VTE risk assessment scales have not been developed for pediatric patients, nor have bleeding risk assessment scales for 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 [121, 123].

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

• Pediatric patients at high risk for VTE are recommended to be considered for prophylactic doses of UFH or LMWH [119, 125, 126].

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

Comment: For pediatric patients, the use of LMWHs from group B01AB is preferred [125, 126] (preferably #Enoxaparin [123]), but currently, the use of all LMWHs is contraindicated in children in Russia; therefore, their prescription is possible only by decision of a medical committee (prescription “ off label”). Some foreign guidelines mention the use of direct oral anticoagulants (#rivaroxaban**) for VTE prophylaxis in children [123], but currently, there is insufficient clinical evidence of their efficacy and safety in this patient category [122, 124].

To decide on pharmacological VTE prophylaxis, a consultation with a pediatrician or hematologist experienced in treating thrombosis in children is recommended. When prescribing anticoagulants to children, it is advisable to monitor general clinical blood test parameters within 48 hours after starting treatment with enoxaparin or heparin [120]. According to indications, anti-Xa levels should be determined 4–6 hours after the administration of #enoxaparin sodium** (target anti-Xa level 0.1–0.3 IU/mL). Routine monitoring of anti-Xa levels is not recommended [127]. Re-checking anti-Xa may be considered if active bleeding or signs of renal dysfunction develop during #enoxaparin sodium** therapy [56]. When prescribing anticoagulants to children, the glomerular filtration rate is calculated using the modified Schwartz formula (http://nephron.com/peds_nic.cgi).

Surgical antibiotic prophylaxis

• In the surgical treatment of patients with closed proximal humerus fractures, surgical antibiotic prophylaxis (SAP) for surgical site infection by a single preoperative administration of an antibacterial drug is recommended [46].

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

Comments: In accordance with international clinical guidelines for the prevention of surgical site infections [47, 48], the objective of surgical antibiotic prophylaxis (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 not associated with the placement of orthopedic implants and metal hardware. SAP should be administered: 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 performed instead.

Comments: For patients with an unremarkable allergic history and without significant risk factors for methicillin-resistant staphylococci 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 starting 2 hours prior to the incision, or #clindamycin** should be prescribed. When significant risk factors for methicillin-resistant staphylococci (MRS) carriage are present, the SAP regimen must include an antibiotic with anti-MRS activity (vancomycin**). In most cases, a single preoperative dose of the antibiotic is sufficient for effective prophylaxis. For prolonged procedures or massive blood loss, an additional intraoperative dose of the antibiotic should be administered (the estimated timing for intraoperative administration is two half-lives after the preoperative dose). Administering an antibiotic after wound closure in the operating room is impractical even if indwelling drains are present.

Single doses of the main antibacterial drugs for SAP in adult traumatology and orthopedic procedures: cefazolin** 2 g (for 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. [48].

Single doses for children should be calculated based on actual weight in accordance with the attached drug instructions: 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 formation when growth plates are open is contraindicated due to the risk of arthropathy development [48].

Comments: In cases of open fractures, prophylactic antibiotic administration is effective in preventing early infection. Antibiotics should be administered as soon as possible after the injury; the antibiotic of choice is cefazolin**. However, for patients with open high-energy fractures with displacement and segmental bone loss; major vascular injury; or heavily contaminated wounds, it is advisable to broaden the spectrum of administered antibiotics to cover Gram-negative pathogens. In such cases, adding #gentamicin** (at a dose of 6 mcg/kg once daily) to cefazolin** may be considered [50, 51]. An alternative to this combination in adults can be #ampicillin+sulbactam** (at a dose of 3.0 g every 8 hours for 3 days) [52], with the latter being particularly relevant in case of a risk of clostridial infection. According to the majority of researchers, in Gustilo–Anderson type III open fractures, antibiotics should not be continued for more than 72 hours after soft-tissue wound closure [53].

Blood-saving techniques

Comments: Tranexamic acid** effectively reduces blood loss and leads to a smaller decrease in postoperative hemoglobin levels in patients undergoing surgery for proximal humeral fractures. This effect is observed both in fracture osteosynthesis and shoulder arthroplasty. Randomized clinical trials in adults 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 [56]. In children, tranexamic acid is prescribed in accordance with the instructions for use in patients over one year of age undergoing surgeries with an expected blood loss of at least 10% of the circulating blood volume [138].

Comments: Systematic reviews and meta-analyses demonstrate that perioperative administration of intravenous iron preparations, specifically ferric carboxymaltose**, in trauma and orthopedic patients, particularly 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 [57, 58].

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 [139, 140]. Data on the use of these drugs in children in the postoperative period following trauma surgeries are lacking.

3.2 Surgical Treatment

- displaced fractures (according to the Neer classification, fragment displacement of more than 1 cm and angular deformity of more than 45 degrees);

- intra-articular fractures with splitting of the humeral head;

- fractures associated with neurovascular deficits;

- open fractures;

- unstable fractures with damage to the medial cortical layer;

- floating shoulder;

- proximal humeral fractures as part of polytrauma;

- irreducible fracture-dislocations of the proximal humerus;

- in children, epiphyseolysis and osteoepiphyseolysis fractures with displacement following a single failed closed reduction attempt [1, 19, 130, 132].

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

3.2.1 Intramedullary Osteosynthesis

Comments: Intramedullary osteosynthesis is a minimally invasive surgical fixation technique for proximal humeral fractures. It is applicable when closed reduction of bone fragments and their maintenance in an anatomical position throughout the procedure are feasible. This technique minimizes soft tissue trauma and disruption of local blood supply [1]. Modern intramedullary implants for proximal humerus allow for osteosynthesis of three- and four-part proximal humeral fractures in selected cases, although fractures of the surgical neck of the humerus in young patients remain the traditional indication [59].

In children, it is permissible to use flexible intramedullary nails crossing the growth plate with subsequent removal after 3–6 months; Kirschner wires can also be used for fragment stabilization.

3.2.2 Percutaneous osteosynthesis

Comments: Indications for percutaneous fixation of PHF include two-part fractures of the surgical neck of the humerus, greater or lesser tuberosity fractures, three-part fractures combined with injury to one of the tuberosities, and four-part impacted valgus fractures. Prerequisites for stable percutaneous fixation are satisfactory fragment alignment after closed reduction, good bone quality, and an intact medial cortical layer. This osteosynthesis method requires patient monitoring in the early postoperative period and supervision of limb immobilization [59].

Osteosynthesis is performed using threaded wires inserted in various directions to fix the bone fragments [59].

Biomechanical studies have demonstrated that percutaneous fixation provides lower stability of bone fragments compared to open reduction and internal

fixation (ORIF); however, this can be compensated for by using larger-diameter wires and increasing the number of wires inserted in different directions [59]. This circumstance likely accounts for the higher complication rate (28.4%) observed with percutaneous fixation compared to alternative surgical treatments for PHF (ranging from 11.3% to 18.9%) [59].

3.2.3 Plate osteosynthesis

For the pediatric population – Level of recommendation C (Level of evidence 5)

For the adult population – Level of recommendation B (Level of evidence 3)

Comments: The development of implants for extra-articular osteosynthesis and the introduction of plates with angular screw stability have made this method of surgical treatment the current method of choice for managing patients with displaced two-, three-, and four-part proximal humeral fractures [59]. The use of angular-stable implants provides more reliable fragment fixation in cases of reduced bone mineral density. In addition, the insertion of a so-called "calcar" screw with angular stability (passing into the humeral head in the area of the medial cortical layer) reduces the risk of varus deformity and improves functional outcomes [1, 63]. When applying the plate to the bone, care must be taken to ensure that the implant is not positioned too high, as this can lead to impingement syndrome, whereas a too-low position results in inadequate fixation of the humeral head and instability [59]. The correct plate position is considered to be: 5–8 mm distal to the apex of the greater tuberosity; the plate axis parallel to the shaft axis of the humerus; 2–4 mm posterior to the bicipital groove of the long head of the biceps [1].

3.2.4 Hemiarthroplasty

Comments: Hemiarthroplasty is a technically demanding surgical procedure. When compared with hemiarthroplasty, ORIF demonstrates higher functional outcomes and patient satisfaction rates. This is primarily true for three-part fractures. As Neer's studies showed back in 1970, in the case of four-part proximal humeral fractures, plate fixation fails in 100% of cases, although angular-stable plates with better fixation capabilities were not available at that time. At the same time, hemiarthroplasty allowed the authors to achieve good and excellent results in 96.9% and 73% of patients with three- and four-part proximal humeral fractures, respectively [64, 65]. It is also worth noting that the complication rate is higher with plate osteosynthesis of complex four-part proximal humeral fractures than with arthroplasty [59].

The authors cite preserved function of the rotator cuff and anatomical restoration of the humeral tuberosities as the key to a successful outcome of proximal humeral endoprosthesis replacement [1, 64].

Comments: Hemiarthroplasty is indicated in cases of high risk of ischemia in damaged bone fragments and subsequent avascular necrosis of the bone tissue. Risk factors for this include damage to the medial cortical layer with fragment displacement and four-part proximal humeral fracture-dislocations [64].

Functional outcomes of treating patients with proximal humeral fractures using hemiarthroplasty are controversial. Mighell et al. [67] report that 93% of patients were pain-free in the postoperative period and satisfied with the treatment outcome. However, a number of authors report the opposite. Boileau et al. [66] report that 42% of patients demonstrated unsatisfactory functional outcomes after hemiarthroplasty. Boons et al. [68] conclude in their study that there are no significant differences in functional outcomes between patients who underwent hemiarthroplasty and patients with four-part proximal humeral fractures treated conservatively. Therefore, the surgeon must always keep in mind the potential risk of a significant decrease in shoulder function in the patient after joint replacement [64].

3.2.5 Reverse Shoulder Arthroplasty

Comments: According to numerous scientific publications, patients who undergo reverse shoulder arthroplasty demonstrate functional outcomes similar to those of patients after hemiarthroplasty; however, the need for revision procedures is significantly lower in the case of reverse shoulder arthroplasty [59, 70-73].

3.3 Other Treatment

Comments: In accordance with paragraphs 4156-4157 of the Sanitary Rules and Norms on Prevention of Infectious Diseases (SanPiN 3.3686-21), emergency tetanus prophylaxis is carried out for any injuries involving a violation of the integrity of the skin and mucous membranes. Emergency tetanus prophylaxis is performed up to the 20th calendar day from the moment of injury [82]. The prescription of drugs for emergency tetanus immunoprophylaxis is carried out differentially depending on the availability of documentary confirmation of a preventive vaccination or immunological monitoring data on the intensity of anti-tetanus immunity, as well as taking into account the nature of the injuries.

Emergency tetanus immunoprophylaxis is carried out, taking into account age restrictions, in the form of:

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

- active-passive prophylaxis, consisting of the simultaneous administration into different parts of the body of human 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 - Td-toxoid) to stimulate immunity in previously vaccinated individuals [82, 83].

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Comments: The program is prescribed by a physical and rehabilitation medicine (PRM) physician / exercise therapy physician and is carried out at home. After 5-6 days, for the period of performing the exercises, the immobilizing bandage is removed, and movements in the elbow joint (possibly with the help of the healthy arm) and pendulum movements with the freely hanging arm in the shoulder joint are performed.

Comments: Depending on the severity of functional impairment in the limb, the PRM / exercise therapy physician decides on the location for further rehabilitation: at home or in a day hospital for more severe dysfunction requiring the combined use of rehabilitation modalities (massage, physiotherapy, mechanotherapy)

Comments: The rehabilitation program is tailored individually, taking into account the patient's age, general condition, including cognitive impairment, and the severity of functional impairment in the arm.

Comments: Massage and physical therapy reduce tissue edema and pain, increase tissue elasticity, and improve microcirculation.

Comments: The general objectives of the early postoperative period are the prevention of cardiovascular and pulmonary postoperative complications. Local objectives include reducing soft tissue edema, creating optimal anatomical and physiological conditions for the healing of tissues traumatized during surgery, reducing pain, improving blood circulation in the limb, and preventing joint stiffness.

Comments: The early rehabilitation program includes cryotherapy, electroanalgesia, and hardware massage; the outpatient rehabilitation program—after suture removal and in the absence of inflammation in the surgical area—includes manual massage of the shoulder and scapular muscles to improve blood circulation and the functional state of the muscles [1].

Comments: Literature data on the duration of rehabilitation periods are inconsistent; some authors distinguish a fourth period, but the necessity of postoperative rehabilitation is reliably demonstrated.

Comments: Immediately after surgery, the arm is immobilized in an orthosis; the duration of wear and type of orthosis are determined by the operating surgeon based on the individual characteristics of the surgical procedure performed.

The orthosis provides rest to the surgical site, which prevents joint dislocation and helps reduce pain and improve soft tissue healing. At this stage (0–3 weeks), the orthosis is removed only to perform exercises.

Before discharge from the hospital, the patient is consulted by a PRM physician/exercise therapy specialist who formulates an individual rehabilitation program with recommendations regarding the activity regimen and necessary home exercises.

Comments: Rehabilitation is carried out at home or on an outpatient basis under the dynamic supervision of a physical and rehabilitation medicine (PRM) physician / exercise therapy (ET) specialist. Active-assisted and active movements in the shoulder joint are performed within a pain-free range of motion in the sagittal and frontal planes. External rotation is not permitted for 6 weeks. Wearing an orthosis during this period is not mandatory, but is recommended in crowded places, such as public transport or walking in a crowd. The arm can be used for self-care, but nothing heavy should be lifted, except for a cup of coffee and only in front of the body.

Comments: Rehabilitation is carried out at home, on an outpatient basis, or in a day hospital. The program is developed by a PRM/ET physician and includes isotonic, concentric, and eccentric exercises, as well as passive tissue stretching in case of contracture (in patients with normal bone structure and signs of fusion on radiography).

For up to 6 months after surgery, nothing heavier than 3 kg should be lifted. The weight should never be raised above the head, only to eye level while visible. Jerks and sudden pushes are not allowed.

Swimming and table tennis are possible at 4–6 months [97].

Comments:

Methodological guidelines for performing physical exercises are as follows:

- early initiation of exercise;

- slow execution pace with fixation at end-range positions and maximum possible muscle involvement and soft tissue stretching;

- use of active exercises only with progressive resistance: active-assisted, in simplified conditions, using pulley and other mechanotherapy devices, active free exercises, active exercises with additional resistance, isometric, static, and against resistance;

- abduction in the shoulder joint must always be performed in the plane of the scapula.

passive mechanotherapy and complex combined movements, especially taking the arm behind the back, are not used in the initial stages of rehabilitation

- exercise may cause discomfort, but must never cause pain;

all exercises are performed daily, 4–5 times a day; each exercise is repeated 5–10 times.

5. Prevention and Dispensary Observation

Prevention of humeral fractures consists in citizens observing social safety rules when performing household chores, being in 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: Upon discharge from the hospital, the patient must be referred to a trauma center or outpatient traumatology department, indicating the treatment provided 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 of the humerus / humeral head and assessment of functional recovery dynamics are performed at 6–8 weeks postoperatively (assessment of fracture consolidation and the possibility of full limb loading in extra-articular fractures), 12 weeks postoperatively (assessment of fracture consolidation and the possibility of limb loading in intra-articular fractures), 24 weeks postoperatively (assessment of functional recovery dynamics), and 1 year postoperatively (assessment of the functional outcome of treatment and deciding on the need and timing of implant removal. In children, the timing of implant removal is considered depending on whether implants cross the growth plate or not, as well as age, following adult principles after 15 years of age).

6. Organization of Medical Care

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

Purpose of clinical recommendations: Clinical recommendations have been developed to improve the quality of medical care and standardize diagnostic and treatment algorithms for patients with proximal humeral fractures.

Indications for planned hospitalization:

unsatisfactory result of conservative treatment: absence of signs of proximal humeral fracture consolidation after conservative treatment or osteosynthesis surgery within 2.5–3.5 months after trauma or surgery [1, 49].

Indications for emergency hospitalization:

Patients with suspected or confirmed proximal humeral fractures must be referred to a hospital to decide on the need for emergency hospitalization. Indications for emergency hospitalization are:

- fracture with significant displacement, i.e., fragment displacement of more than 1 cm, angular deformity of more than 45 degrees;

- intra-articular proximal humeral fractures with head splitting or articular surface impression;

- pathological proximal humeral fracture;

- combination of proximal humeral fracture with vascular or neurological disorders;

- open proximal humeral fracture;

- proximal humeral fracture as part of polytrauma;

- ipsilateral fractures of the proximal humerus and other upper extremity segments;

- flail shoulder;

- fracture-dislocation in children.

Indications for patient discharge from the hospital:

1. Internal fixation of the fracture with hardware, shoulder arthroplasty, or adequate plaster immobilization for 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 case of legally established patient incapacity) to continue inpatient treatment (the reason for refusal must be documented in the medical history 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 (Disabilities of the Arm, Shoulder, and Hand, DASH) questionnaire was developed jointly by the American Academy of Orthopaedic Surgeons, the Council of Musculoskeletal Specialty Societies, and the Institute for Work and Health (Canada). It belongs to 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 [101]. 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 upper extremity musculoskeletal disorders [102]. DASH has two optional modules (four items each) designed for athletes, musicians, and workers whose activities require special physical conditioning and whose functional limitations may only arise under high loads exceeding the scope of the 30 DASH items. Approved translated versions of DASH in 56 languages and dialects, including Russian, are available on the website of the Institute for Work and Health (Canada), which holds the copyright for the questionnaire (https://dash.iwh.on.ca/available-translations).

2) The Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) is an 11-item shortened version of the DASH questionnaire with the same response options [103, 104]. Like DASH, it is designed for patient self-assessment of upper extremity function in various diseases and injuries. QuickDASH also features two optional modules (four items each) intended for athletes, musicians, and workers whose activities require specific physical conditioning, where functional limitations may only appear at high exertion levels exceeding the 11 items of the QuickDASH. The optional modules are evaluated separately. In a number of studies, comparing the DASH and QuickDASH questionnaires showed that both instruments have approximately equal sensitivity, specificity [105–109], and minimal clinically important difference (12–14 points for DASH and 12–15 points for QuickDASH) [110]. In a systematic review of 23 self-assessment instruments for patients with various upper extremity pathologies, the QuickDASH demonstrated the highest content and construct validity, reliability, and responsiveness [111]. There are reports of successful use of QuickDASH in children aged 8–18 years [112, 113]. Approved translation versions of QuickDASH in 56 languages and dialects, including Russian, are available on the website of the Institute for Work & Health (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 I.I. Джанелидзе Research Institute of Emergency Medicine, St. Petersburg, member of ATOR.

2. Bozhkova S.A., MD, Vreden National Medical Research Center of Traumatology and Orthopedics 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., PhD, Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine, Pavlov First Saint Petersburg State Medical University, St. Petersburg, member of ATOR.

6. Nazarenko A.G., MD, Professor of the RAS, Director of the Priorov National Medical Research Center of Traumatology and Orthopedics of the Ministry of Health of the Russian Federation, 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 I.I. Dzhanelidze Research Institute of Emergency Medicine, St. Petersburg, member of ATOR.

Conflict of interest.

The working group for drafting clinical guidelines for the treatment of proximal humeral 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. 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 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

Appendix A3.1 Pain management recommendations for major musculoskeletal trauma (surgical fixation of long bone fractures or complex joint fractures, extensive soft tissue trauma, extensive surgery, etc.) in adults

The table presents analgesic medications and their dosage regimens in accordance with the clinical guidelines for pain management in acute musculoskeletal trauma [25].

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

Appendix A3.3. Recommendations for Postoperative Analgesia in Children

¹ In children under 12 years of age, morphine** is the preferred agent when opioid analgesics are indicated, as the use of tramadol** is associated with a higher risk of adverse reactions [40, 134].

² Not recommended for use in children because its metabolite accumulates in the body and provokes seizures upon repeated administration [38].

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

Appendix A3.5. Bleeding Risk Factors in Children Aged 6 Months to 18 Years

Notes:

1. If the patient meets at least one of the "NOT recommended" criteria, avoid pharmacological prophylaxis, as the risk outweighs the benefit.

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

3. Consider a hematology consultation if the patient is at high VTE risk with a high bleeding risk [119].

4. Uncontrolled hypertension is defined as systolic or diastolic blood pressure above the 95th percentile for age, height, and sex [120].

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

Appendix A3.6. VTE risk factors in children aged 6 months to 18 years [113, 129]

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 factor

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 physician actions in suspected humerus fracture

Appendix B2. Algorithm for assessing cardiovascular risk of surgery

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

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

rRCRI - reconstructed RCRI index (See Appendix G2);

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

*- regional vascular center or specialized cardiological department.

Appendix C. Patient Information

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 = ([sum of n responses]/n - 1) × 25, 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. 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 vascular surgery above the groin) - 1 point.

2. Coronary artery disease (myocardial infarction, positive stress test, angina, use of nitroglycerin, pathological Q wave on ECG) - 1 point.

3. Heart failure (history of heart failure, pulmonary edema, paroxysmal nocturnal dyspnea, bilateral 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 [114] to predict the risk of perioperative cardiac complications in non-cardiac surgery. It was validated in the Lee study [115], and in 2013 [116] it was revised and re-validated based on clinical risk factors (replacing the criterion "creatinine level >176.8 µmol/L" with "creatinine clearance <30 mL/min"; the clinical criterion "insulin-dependent diabetes mellitus" was removed), hence it is called the reconstructed index. It includes 5 parameters, each assigned 1 point. This specific version of the index is recommended by the Russian Society of Cardiology [15].