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This is a randomized trial comparing conservative with surgical treatment (with open reduction and locking plate fixation) for proximal humeral fractures in patients aged more than 60 years.
Different methods have been used in the treatment of proximal humeral fractures. Usually, treatment choice depends on fracture displacement, patient age, osteoporosis, and other characteristics. Locking plate fixation has become the most widely used method among surgical techniques, while partial arthroplasty is reserved for older patients and comminuted articular fractures. Generally, nonsurgical treatment involves a brief period with sling immobilization and physiotherapy rehabilitation.
A recent multicenter study showed no difference between conservative and surgical treatments, including internal fixation with locking plates. Two other randomized studies showed mixed results, with no relevant clinical differences between the methods. No previous trial has evaluated the quality of reduction in surgically treated fractures and its relation to outcomes. Our study aims to compare both techniques with a detailed radiographic and tomographic evaluation, in elderly patients. We also aim to evaluate the influence of reduction and plate positioning on clinical outcomes. This is a single center trial, in which surgeries will be performed by only two experienced surgeons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locking plate | Experimental | Surgical treatment with open reduction and osteosynthesis with locking plate |
|
| Conservative | Active Comparator | Conservative treatment with sling and rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteosynthesis with locking plate | Procedure | Open reduction and osteosynthesis with locking plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Individual relative Constant-Murley score | Constant-Murley score relative to the unaffected shoulder | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons Shoulder (ASES) score | Subjective functional evaluation | 2 years |
| Constant-Murley score | 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo - Department of Orthopedics and Traumatology | Recruiting | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727196 | Derived | Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Sling | Procedure | Conservative treatment with sling and rehabilitation |
|
| 12-Item Short Form Health Survey (SF-12) |
Quality of life evaluation |
| 2 years |
| Visual analog scale (VAS) for pain | 2 years |
| Complication and reoperation rate | 2 years |
| Radiographic evaluation | Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria | 2 years |
| Rotator cuff ultrasound and magnetic resonance | 2 years |
| D019736 |
| Prostheses and Implants |
| D004864 | Equipment and Supplies |