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Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees

NCT07420192 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Symptomatic Neuroma
  • Phantom Limb Pain After Amputation
  • Residual Limb Pain
  • Neuropathic Pain
  • Lower Extremity Amputations

Interventions

PROCEDURE

Regenerative Peripheral Nerve Interface (RPNI) Surgery

The surgical procedure is standardized as follows to preserve the residual limb (stump) anatomy: * Approach: An 8-10 cm incision is made on the lateral thigh. For transtibial (below-knee) amputees, the incision is placed approximately 15 cm proximal to the knee joint. For transfemoral (above-knee) amputees, it is placed 5-10 cm proximal to the distal end of the residual limb. * Nerve Dissection: The sciatic nerve is isolated, dissected, and transected at its most distal point. Subsequently, it is separated into the Common Peroneal and Tibial divisions. * Fascicular Separation: Based on nerve thickness, intraneural dissection is performed to split the Common Peroneal nerve into 1 or 2 fascicles, and the Tibial nerve into 2 to 4 fascicles. * Graft Harvesting: Autologous muscle grafts are harvested to wrap these created fascicles. The donor site is standardized by amputation level: Vastus Lateralis muscle for transtibial amputees and Biceps Femoris muscle for transfemoral amputees.

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi

    lead OTHER

Principal Investigators

  • Ahmet Burak Bilekli, MD, Associate Professor · University of Health Sciences, Gülhane Training and Research Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2029-11-30
Completion
2030-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07420192 on ClinicalTrials.gov