Study of Regenerative Peripheral Nerve Interface RPNI Surgery to Reduce Neuropathic Pain and Improve Function in Adults with Major Lower Limb Amputations

What this Trial Is About

This research aims to evaluate the long-term outcomes of Regenerative Peripheral Nerve Interface RPNI surgery in adults with major lower limb amputations who experience painful neuromas. RPNI is a surgical technique where the cut nerve end is placed into a muscle graft to encourage natural nerve growth and reduce nerve pain. The study focuses on measuring changes in pain sensitivity, neuropathic pain symptoms, functional mobility, and satisfaction with prosthetic use over a 24-month period compared to before surgery. Participants undergo the standard RPNI surgical procedure, which includes harvesting a small muscle graft from specific donor sites depending on the amputation level. The nerve end is carefully prepared and implanted into the muscle graft to promote nerve healing. The study also observes unique factors such as pain related to pelvic nerve activity and the ability to move the phantom limb. The surgery and follow-up assessments follow a structured timeline at 3, 6, 12, and 24 months post-operation. During the study, participants are assessed multiple times using objective tools like a digital device measuring pressure pain threshold, and questionnaires evaluating pain intensity, neuropathic symptoms, prosthesis satisfaction, and mobility tests. Researchers also monitor daily prosthesis use and signs of new bone growth. The study uses standardized clinical tests and imaging to confirm neuroma presence and tracks changes over two years. Safety and functional outcomes are carefully recorded to understand the surgerys impact.

Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees