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Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain

NCT05344261 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-12-05

No results posted yet for this study

Summary

The purpose of this study is to analyze the efficacy of novel interventions in post-amputation surgical care (specifically Targeted Muscle Reinnervation and Regenerative Peripheral Nerve Interface) on post-amputation pain and functional outcomes at the time of amputation. These novel interventions have been shown to be successful in treating the downstream effects of amputations (pain, phantom limb pain, neuroma pain, etc.), but has not been studied in a randomized manner at the time of amputation.

Conditions

  • Amputation
  • Neuroma Amputation
  • Phantom Limb Pain
  • Residual Limbs

Interventions

PROCEDURE

Targeted Muscle Re-innervation

Targeted Muscle Re-innervation involves re-routing transected nerve ends to functional motor nerves proximal to the site of amputation.

PROCEDURE

Regenerative Peripheral Nerve Interface

Regenerative Peripheral Nerve Interface involves placing transected nerve ends in harvested muscle grafts.

PROCEDURE

Standard Post-Amputation Surgical Care

Standard post-amputation surgical care involves placing transected nerve ends into muscle/soft tissue proximal to the site of amputation.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Deborah Noble · UT Southwestern Department of Plastic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-12-30
Completion
2024-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05344261 on ClinicalTrials.gov