Randomized clinical trial of Proximal humeral fractures in three or four parts in elderly: Blocked plate with or without Synthetic graft augmentation

INTERVENTION: S42.2 Sixty‐four patients, 32 in the study group and 32 in the control group, will be operated by the main researcher (A.C.T.J.), in beach chair position, under general anesthesia and brachial plexus block, through the deltopectoral approuch. The tuberosities will be repaired with high‐strength wires and opened "in a book" to reduce the articular surface by elevation, if impacted, and reduction, if displaced. After epiphysis reduction, checked by fluoroscopy, temporary fixation will be performed with 2 steel Kirschner wires, 2 mm in diameter and 280 mm in length. The humerus tuberosities will be reduced by ligation, with high‐strength wires joining them together and definitive osteosynthesis, which will be performed with an anatomic angular stability plate for proximal humerus, low profile, made of surgical steel, with 3 holes conjugates (for cortical and locking screws) in the diaphysis positioned approximately between 2 and 4 mm posterior to the biceps gutter, between 5 and 8 mm distal to the top of the greater tubercle, aligned with the long axis of the humeral diaphysis, fixed with 3 bicortical screws in the diaphysis (1 cortical and 2 blocking screws) and 6 unicortical blocking screws in the humeral head, approximately 0.5 cm from the articular cartilage. In all cases, medial column support screws will be used. The height and position of the plate and the length of the screws will be checked by intraoperative fluoroscopy in the true anteroposterior view with neutral, lateral and medial rotations of the shoulder. In the study group, after reduction of the humeral head and before reduction of the tuberosities, the bone defect formed between the epiphysis and the metaphysis of the humerus will be filled with 10 ml of calcium sulfate cement introduced in pasty form through t CONDITION: C26.404.625 Proximal Humeral Fractures PRIMARY OUTCOME: Patients will be clinically evaluated according to the Constant‐Murley score, a questionnaire that assesses the different domains of shoulder functions, such as pain, activities of daily living, range of motion and muscle strength to perform anterior shoulder elevation, by an external evaluator, in which higher scores are indicative of better function. It is expected to find a higher score in the Constant‐Murley score in the study group. SECONDARY OUTCOME: Lower rates of complications such as joint penetration of screws, loosening of the plate, osteonecrosis of the humeral head and fracture non‐consolidation are expected in the study group. Patients will be evaluated by means of radiographs, which will assess the reestablishment of anatomical parameters of the proximal end of the humerus between the study and control groups. Fracture reduction will be evaluated by measuring the height of the humeral head and the angle formed between the head and the diaphysis of the humerus, both measured in the true anteroposterior view of the standardized shoulder. Better anatomical recovery is expected in the study group. INCLUSION CRITERIA: Proximal humeral fractures in 3 or 4 parts; involvement of the surgical neck; tuberosities deviation greater than 0.5 cm; contact between the diaphysis and the humeral head fragment smaller then fifty percent; patient aged over or equal to sixty years old; maximum time of fracture of 14 days