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Unable to meet enrollment goals and lack of patient follow-up
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Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures.
Metacarpal fractures are a common injury to the hand. Most fractures occur due to direct force from either a axial load to the dorsum of the metacarpophalangeal joint or low energy fall onto an outstretched hand. Many of these fractures can be treated closed with a closed reduction and splinting however, some displaced or angulated fractures require open reduction and internal fixation. Many fixation techniques have been used, however to the investigators knowledge, no one has prospectively randomized patients to compare plate and screw fixation with buried intramedullary k-wire fixation.
The purpose of this study is to compare Plate and screw and buried intramedullary fixation, using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as the primary outcome measured. Secondary outcomes will include total active motion, complications, cost, reoperation rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buried Intramedullary K-wire Fixation | Experimental | Patients randomized to buried intramedullary k-wire fixation will undergo a standardized antegrade open reduction and fixation procedure with an intramedullary k-wire. |
|
| Plate and Screw Fixation | Active Comparator | Patients randomized to Plate and Screw Fixation will undergo a standardized open reduction and internal fixation with plate and screws. Brand of plate will be left to the operating surgeon's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buried Intramedullary K-wire Fixation | Procedure |
| ||
| Plate and Screw Fixation |
| Measure | Description | Time Frame |
|---|---|---|
| Disability as measured by Disability of Arm, Shoulder and Hand Score | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Active Motion in degrees | Measured by goniometer | 3 months |
| Grip Strength | 3 months | |
| Disability as measured by Disability of Arm, Shoulder and Hand Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Millon, MD | Prisma Health-Upstate | Principal Investigator |
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| Procedure |
|
| 1 year |
| ID | Term |
|---|---|
| D001860 | Bone Plates |
| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |
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