Comparing Three Surgical Methods to Relieve Postamputation Pain including Targeted Muscle Reinnervation, Regenerative Peripheral Nerve Interface, and Standard Neuroma Treatment

What this Trial Is About

This research aims to compare the effectiveness of three surgical methods for reducing residual limb pain, neuroma pain, and phantom limb pain in people who have had a major limb amputation. These types of pain fall under the category of postamputation pain, which can have different causes requiring specific treatments. The trial is a multi-center, double-blind, randomized controlled study conducted at nine hospitals across seven countries, involving 110 participants. The study will follow participants for up to four years to observe how pain changes after surgery. The three surgical treatments being studied are Targeted Muscle Reinnervation TMR, Regenerative Peripheral Nerve Interface RPNI, and standard neuroma treatment involving neuroma excision and muscle burying. Each surgery takes place in a hospital, lasting about 1 to 3 hours depending on the method. TMR involves rerouting injured nerves to nearby motor nerves RPNI involves splitting the nerve into fascicles and wrapping them in muscle grafts the standard treatment removes the painful neuroma and buries the nerve in nearby muscle tissue. Participants are randomly assigned to one of these treatments in equal groups. Participants will be followed up at 1, 3, 6, and 12 months after surgery, and again at 2 and 4 years to assess pain levels. Questionnaires previously used in clinical settings will measure residual limb pain, neuroma pain, and phantom limb pain intensity. After 12 months, participants and evaluators will learn which treatment was given, and those unhappy with results can discuss alternative treatments with their clinical investigator. The primary outcome measured is residual limb pain intensity from baseline to 12 months post-surgery, with secondary measures including neuroma and phantom limb pain intensities over the same period.

Surgical Treatments for Postamputation Pain