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Regenerative Peripheral Nerve Interfaces for the Treatment of Painful Neuromas in Major Limb Amputees

NCT07285486 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2025-12-16

No results posted yet for this study

Summary

The Regenerative Peripheral Nerve Interface (RPNI) is a novel strategy to prevent neuroma formation in transected peripheral nerves. The RPNI consists of a residual peripheral nerve that is implanted into a free skeletal muscle graft either at the time of limb amputation or after excision of a terminal neuroma bulb. The sprouting axons of the nerve readily reinnervate the free muscle graft, thereby greatly reducing the chance of neuroma formation.

This investigation has a prospective cohort study design involving major lower limb amputees drawn from both the University of Michigan Health Systems and VA Health System of Ann Arbor. To objectively evaluate the effect of RPNI surgery on patients' perception of pain and to measure other health-related quality of life metrics relating to neuroma pain, this clinical trial will utilize specific, validated patient-reported outcomes measures (PROMs) to assess targeted domains in patients with major limb amputation. These survey instruments will determine: 1) patterns of pain medication use, including the use of opioids, 2) functional status and use of a prosthetic device, 3) changes in neuroma pain quality, 4) limitations in activities of daily living due to neuroma pain, 5) depression and anxiety relating to neuroma pain.

Conditions

  • Amputation Neuroma

Interventions

PROCEDURE

Amputation with Regenerative Peripheral Nerve Interfaces (RPNI)

Free-muscle graft over cut nerve ends for treatment of neuromas at site of an amputation.

OTHER

Amputation Without RPNI

Standard of care for lower-extremity amputation

Sponsors & Collaborators

Principal Investigators

  • Theodore Kung, MD · University of Michigan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2023-06-26
Completion
2023-06-26

Countries

  • United States

Study Locations

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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 NCT07285486 on ClinicalTrials.gov