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inadequate enrollment
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| Name | Class |
|---|---|
| American Society for Surgery of the Hand | OTHER |
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Finger amputations are common and may be complicated by debilitating nerve pain. This study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (TMR) or regenerative peripheral nerve interfaces (RPNI)-compared to standard treatment by traction neurectomy (TN).
Patients who require proximal amputations will have the opportunity to enroll in the study, will be randomized intraoperatively to receiving one of the aforementioned treatments, and will be followed at 3 and 6 month for outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traction Neurectomy | Active Comparator | Traction neurectomy - of digital sensory nerves at the time of amputation. |
|
| Targeted Muscle Reinnervation | Experimental | Targeted Muscle Reinnervation - of digital sensory nerves at the time of amputation |
|
| Regenerative Peripheral Nerve Interface | Experimental | Regenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital nerve procedure | Procedure | The type of procedure performed on the digital nerve at the time of amputation |
|
| Measure | Description | Time Frame |
|---|---|---|
| bMHQ | Breif Michigan Hand Questionnaire Score difference | 3 months postop minus preop; 6 months postop minus preop |
| Measure | Description | Time Frame |
|---|---|---|
| NPS | Numerical Pain Score difference | 3 months postop minus preop; 6 months postop minus preop |
| Grip strength | Grip strength score difference |
| Measure | Description | Time Frame |
|---|---|---|
| Tinel's sign | Tinel's sign at amputation site | Tinel's sign at 3 months; Tinel's sign at 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Adkinson, MD | Indiana University | Principal Investigator |
| Scott N Loewenstein, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3 months postop minus preop; 6 months postop minus preop |