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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramedullary Locked Nail | Experimental |
| |
| Locked Plate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Locked plate | Device | Osteosynthesis with philos plate, through deltopectoral approach and rotator cuff augmentation with inabsorbable poliester suture |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative integrity of the rotator cuff, evaluated by ultrasonography | Post-operative integrity of the rotator cuff, evaluated by ultrasonography | 6 months |
Inclusion Criteria:
Exclusion Criteria:
Characteristics of the fracture:
Other criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro EC Gracitelli, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Ortopedia e Traumatologia | SĂŁo Paulo | SĂŁo 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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|
| Intramedullary locked nail | Device | Intramedullary locked nail performed by antero-lateral transdeltoid minimally invasive approach and rotator cuff augmentation with inabsorbable poliester suture |
|
|
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
Orthopedic
Related to the implant
| 12 months |
| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| D050723 | Fractures, Bone |
| D006810 | Humeral Fractures |
| D014947 | Wounds and Injuries |
| D001134 | Arm Injuries |
| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
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