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RECRUITING
NCT05009394
NA

Surgical Treatments for Postamputation Pain

Sponsor: Prometei Pain Rehabilitation Center

View on ClinicalTrials.gov

Summary

This is a double-blind randomised controlled trial (RCT) which compares the effectiveness of three surgical techniques for alleviating residual limb pain (RLP), neuroma pain and phantom limb pain (PLP). The three surgical treatments are Targeted Muscles Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and an active control (neuroma excision and muscle burying). Patients will be follow-up for 4 years.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2023-06-20

Completion Date

2029-06

Last Updated

2025-01-09

Healthy Volunteers

No

Interventions

PROCEDURE

Targeted Muscle Reinnervation (TMR)

Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.

PROCEDURE

Regenerative Peripheral Nerve Interface (RPNI)

Surgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.

PROCEDURE

Standard neuroma treatment, neuroma excision, and muscle burying

Surgical procedure where the neuroma is excised and the nerve stump is buried in an adjacent deep muscle.

Locations (9)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Dandenong Hospital, Monash Health

Melbourne, Australia

University of Alberta Hospital

Edmonton, Alberta, Canada

Worker Hospital

Santiago, Chile

Rizzoli Orthopedic Institute

Bologna, Emilia-Romagna, Italy

Sahlgrenska University Hospital

Mölndal, Västra Götaland County, Sweden

NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian

Edinburgh, United Kingdom