Pain After Proximal Digital Amputation Prevention

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Pain After Proximal Digital Amputation Prevention

Conditions
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Pain, Amputation Neuroma, Amputation

Intervention / Treatment
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* Procedure: Digital nerve procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring single finger amputations at the level of the proximal interphalangeal joint or proximal (i.e., closer to the body than this joint). Patients have the capacity to complete the informed consent process Exclusion Criteria: Patients less than 18 years of age, prisoner, or other vulnerable population Patients with significant concomitant ipsilateral extremity injuries that would confound study Patients requiring emergent, staged (guillotine-type) amputations of any kind

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traction Neurectomy<br>Traction neurectomy - of digital sensory nerves at the time of amputation. | Procedure: Digital nerve procedure<br>* The type of procedure performed on the digital nerve at the time of amputation<br>|
| Experimental: Targeted Muscle Reinnervation<br>Targeted Muscle Reinnervation - of digital sensory nerves at the time of amputation | Procedure: Digital nerve procedure<br>* The type of procedure performed on the digital nerve at the time of amputation<br>|
| Experimental: Regenerative Peripheral Nerve Interface<br>Regenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation | Procedure: Digital nerve procedure<br>* The type of procedure performed on the digital nerve at the time of amputation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bMHQ | Breif Michigan Hand Questionnaire Score difference | 3 months postop minus preop; 6 months postop minus preop | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 months postop minus preop; 6 months postop minus preop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Amputation Neuroma, Finger Amputation