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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
| Indiana University | OTHER |
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Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. Some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. There is no evidence to date that either option in superior. For this reason, we propose to conduct a prospective, randomized clinical trial of surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This study will use both objective clinical and patient-based outcome measures. The purpose of this study is to see if there is a difference between clinical outcomes (healing rate, time to healing, time to return to work, Constant Score, complications), functional outcomes (DASH Score), and health related quality of life (SF-36) in nonoperative care and two types of surgical care for displaced fractures of the clavicular shaft in adults.
Included patients will be randomized into one of three groups: nonoperative care (Group N); surgical care using plates and screws (Group P); and surgical care using intramedullary pin put inside of the clavicle to stabilize it (Group I).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed | No Intervention | Closed Treatment | |
| ORIF | Active Comparator | Open Reduction and Internal Fixation (ORIF) with Plate and Screws |
|
| Pin | Active Comparator | Pin Fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORIF with Plate and Screws | Procedure | ORIF with plate and screws |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disability of Arm, Shoulder and Hand (DASH) scores | Disability of Arm, Shoulder and Hand (DASH) scores | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation rate | rate of reoperations between groups | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle J Jeray, MD | Greenville Hospital System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health | Greenville | South Carolina | 29605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38837208 | Derived | Jeray KJ, Broderick JS, Mullis BH, Everhart J, Tanner SL, Snider BG; Southeastern Fracture Consortium. Multicenter, Prospective, Observational Study of Nonoperative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures. J Orthop Trauma. 2024 Jul 1;38(7):345-350. doi: 10.1097/BOT.0000000000002817. |
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| ID | Term |
|---|---|
| D001860 | Bone Plates |
| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
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| Pin Fixation |
| Procedure |
Clavicle fixation with clavicle pin |
|
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |