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Surgical Treatments for Postamputation Pain
Sponsor: Prometei Pain Rehabilitation Center
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
Targeted Muscle Reinnervation (TMR)
Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.
Regenerative Peripheral Nerve Interface (RPNI)
Surgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.
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