Pain After Proximal Digital Amputation Prevention (PAPDAP)

Indiana University

Status: Terminated

Conditions: Amputation Neuroma; Amputation; Pain

Treatments: Procedure: Digital nerve procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04378062

1907889836

Details and patient eligibility

About

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).

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 3 patient groups

Traction Neurectomy

Active Comparator group

Description:

Traction neurectomy - of digital sensory nerves at the time of amputation.

Treatment:

Procedure: Digital nerve procedure

Targeted Muscle Reinnervation

Experimental group

Description:

Targeted Muscle Reinnervation - of digital sensory nerves at the time of amputation

Treatment:

Procedure: Digital nerve procedure

Regenerative Peripheral Nerve Interface

Experimental group

Description:

Regenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation

Treatment:

Procedure: Digital nerve procedure