RecruitingNot ApplicableNCT05009394

Surgical Treatments for Postamputation Pain


Sponsor

Prometei Pain Rehabilitation Center

Enrollment

110 participants

Start Date

Jun 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Regenerative Peripheral Nerve Interface (RPNI), a procedure called Standard neuroma treatment, neuroma excision, and muscle burying, and others for people with amputation neuroma, pain, nerve, and other related conditions. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETargeted Muscle Reinnervation (TMR)

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

PROCEDURERegenerative Peripheral Nerve Interface (RPNI)

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

PROCEDUREStandard 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

View Full Details on ClinicalTrials.gov

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NCT05009394


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