Humerus, Proximal Humeral Fracture, Fractures, Bone, Humeral Fractures, Wounds and Injuries, Arm Injuries
Conditions
Keywords
Humerus, fracture, nail, plate, tuberosity
Brief summary
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.
Interventions
DEVICELocked plate
Osteosynthesis with philos plate, through deltopectoral approach and rotator cuff augmentation with inabsorbable poliester suture
DEVICEIntramedullary locked nail
Intramedullary locked nail performed by antero-lateral transdeltoid minimally invasive approach and rotator cuff augmentation with inabsorbable poliester suture
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score | 12 months | Absolute Constant-Murley Score, that measures: Shoulder function, pain, strength and range of motion 0-100 points score 12 months as the final outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Superior limb function, measured by DASH score | 12 months | Disability of Arm-Shoulder-Hand score |
| Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score | 12 months | Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by University of California Los Angeles score. 0-35 points score |
| Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score | 12 months | 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. |
| Number of patients with complications | 12 months | 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; |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-operative integrity of the rotator cuff, evaluated by ultrasonography | 6 months | Post-operative integrity of the rotator cuff, evaluated by ultrasonography |
Countries
Brazil
Outcome results
None listed