Clinical Trial

Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees

Study acronym: RPNI-AMPUTEE
Recruiting
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Summary
This prospective, observational cohort study evaluates the long-term outcomes of Regenerative Peripheral Nerve Interface (RPNI) surgery in patients with major lower extremity amputations suffering from symptomatic neuromas. RPNI is a surgical technique where the transected nerve end is implanted into a free autologous muscle graft to serve as a physiological target for reinnervation. The study aims to objectively assess the reduction in mechanical hypersensitivity using Pressure Pain Threshold (PPT) measurements via a digital algometer. Additionally, it monitors subjective neuropathic pain levels, functional mobility, and prosthesis satisfaction over a 24-month follow-up period compared to pre-operative baselines.
Trial Details
NCT Number NCT07420192
Lead Sponsor Saglik Bilimleri Universitesi
Conditions Symptomatic Neuroma, Phantom Limb Pain After Amputation, Residual Limb Pain, Neuropathic Pain, Lower Extremity Amputations
Enrollment 20 participants
Start Date 2026-01-20
Primary Completion 2029-11 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-19