Proximal Humerus Fractures: Randomized Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts

Study Overview
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Brief Summary
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The hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the Constant Score.

Official Title
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Proximal Humerus Fractures: Randomized Study Between Intramedullary Locking Nails and Locking Plates for Neer 2 and 3 Parts Displaced Fractures

Conditions
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Humerus, Proximal Humeral Fracture, Fractures, Bone, Humeral Fractures, Wounds and Injuries, Arm Injuries

Intervention / Treatment
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* Device: Locked plate
* Device: Intramedullary locked nail


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fracture with less than 21 days; Fractures of the proximal humerus classified as 2 or 3 parts of Neer, with involvement of the humeral head and one of the tuberosities; Fracture with unacceptable deviation for the non-surgical treatment, according to the criteria of Neer Neer: fractures with deviation greater than 45 ° or 1 cm for the fragment of the humeral head and fractures with a deviation of the tuberosity greater than 0.5 cm; Closed fractures; Exclusion Criteria: Characteristics of the fracture: fracture between the greater tubercle and the smaller, independent of the deviation; Isolated fracture of the greater or lesser tuberosity 4-part fractures of Neer; Fracture involving the articular surface of the humeral head; Fracture-dislocation of the proximal humerus Other criteria: Neurological injuries in the affected limb; previous surgery on the affected shoulder; associated fractures in the affected limb; pathologic fractures; lesions of the rotator cuff tendons previously diagnosed; Psychiatric illnesses or inability to understand preoperative questionnaires; Active infection or previous infection on the shoulder;

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intramedullary Locked Nail<br> | Device: Intramedullary locked nail<br>* Intramedullary locked nail performed by antero-lateral transdeltoid minimally invasive approach and rotator cuff augmentation with inabsorbable poliester suture<br>* Other names: Centronail, Proximal Humeral Nail, Orthofix, Italy;|
| Active Comparator: Locked Plate<br> | Device: Locked plate<br>* Osteosynthesis with philos plate, through deltopectoral approach and rotator cuff augmentation with inabsorbable poliester suture<br>* Other names: Philos plaste, Synthes, Switzerland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score | Absolute Constant-Murley Score, that measures: Shoulder function, pain, strength and range of motion 0-100 points score 12 months as the final outcome | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superior limb function, measured by DASH score | Disability of Arm-Shoulder-Hand score | 12 months | 
| Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score | Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by University of California Los Angeles score. 0-35 points score | 12 months | 
| Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score | Individual Relative Constant-Murley Score, compared to non-injured shoulder. Fialka C, Oberleitner G, Stampfl P, Brannath W, Hexel M, Vécsei V. Modification of the Constant-Murley shoulder score-introduction of the individual relative Constant score Individual shoulder assessment. Injury. 2005 Oct;36(10):1159-65. | 12 months | 
| Number of patients with complications | Overall complications and need for additional surgery, categorized as: Not related to implant Clinical Death in the intraoperative or postoperative period; Clinical complications related to surgery . Orthopedic Infection Osteonecrosis ; Nonunion ; Stiffness Reflex sympathetic dystrophy ; Heterotopic ossification ; Refracture ; Neurological injury . Insufficient reduction; Loss of reduction of the humeral head; Loss of reduction of tubercule: deviation greater than 5 mm between the immediate postoperative radiographs and 12 months; Related to the implant Primary articular protrusion of screws; Loosening of the implant ; Breaking of the implant ; Cutout: loss reduction head with proximal screw pullout ; secondary articular protrusion screws; Malunion Injury to the rotator cuff tendons is observed in postoperative ultrasonography; | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humerus, fracture, nail, plate, tuberosity