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Pain After Proximal Digital Amputation Prevention (PAPDAP)

Indiana University logo

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

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

Trial contacts and locations

1

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Central trial contact

Joshua M Adkinson, M.D.; Scott N Loewenstein, M.D.

Data sourced from clinicaltrials.gov

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