Pain After Proximal Digital Amputation Prevention

Not Applicable

Terminated

• Conditions: Pain; Amputation; Amputation Neuroma
• Interventions: Procedure: Digital nerve procedure

• Registration Number: NCT04378062
• Lead Sponsor: Indiana University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-07
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traction Neurectomy	Digital nerve procedure	Traction neurectomy - of digital sensory nerves at the time of amputation.
Targeted Muscle Reinnervation	Digital nerve procedure	Targeted Muscle Reinnervation - of digital sensory nerves at the time of amputation
Regenerative Peripheral Nerve Interface	Digital nerve procedure	Regenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation

Primary Outcome Measures

Name	Time	Method
bMHQ	3 months postop minus preop; 6 months postop minus preop	Breif Michigan Hand Questionnaire Score difference

Secondary Outcome Measures

Name	Time	Method
Grip strength	3 months postop minus preop; 6 months postop minus preop	Grip strength score difference
NPS	3 months postop minus preop; 6 months postop minus preop	Numerical Pain Score difference

Trial Locations

Locations (1)

Eskenazi Hospital; 🇺🇸 Indianapolis, Indiana, United States