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

University of Michigan

Status: Completed

Conditions: Amputation Neuroma

Treatments: Other: Amputation Without RPNI; Procedure: Amputation with Regenerative Peripheral Nerve Interfaces (RPNI)

Study type: Observational

Funder types: Other

Identifiers

NCT07285486

HUM00120915

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Major lower limb amputation (chronic pain treatment group only)
• Symptomatic residual limb neuroma (chronic pain treatment group only)
• Undergoing a major lower limb amputation (prophylactic pain treatment group only)

Exclusion criteria

• History of chronic amputation-related pain (prophylactic pain treatment group only)
• History of regenerative peripheral nerve interface (RPNI)

Trial design

132 participants in 2 patient groups

Chronic Amputation Pain

Description:

Participants who were existing amputees who had chronic neuroma pain at the amputation site.

Treatment:

Procedure: Amputation with Regenerative Peripheral Nerve Interfaces (RPNI)

Prophylactic Treatment Group

Description:

Participants who had a lower extremity amputated during the study and were prophylactically treated for pain.

Treatment:

Procedure: Amputation with Regenerative Peripheral Nerve Interfaces (RPNI)

Other: Amputation Without RPNI