Regenerative Peripheral Nerve Interface (RPNI) for painful neuromas after lower-limb amputation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational cohort of adults with unilateral major lower-extremity amputations who undergo standard-of-care RPNI surgery for symptomatic neuromas. Participants are selected using a standardized Clinical Triad (validated neuropathic pain questionnaire, a localized Tinel's-trigger point, and ultrasound visualization of the neuroma). Objective mechanical hypersensitivity is measured with Pressure Pain Threshold (PPT) using a digital algometer and compared to preoperative baselines, while subjective neuropathic pain, functional mobility, and prosthesis satisfaction are tracked over 24 months. The study uses routine RPNI surgical technique with a free autologous muscle graft and follows patients longitudinally to characterize long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: Adults aged 18 to 70 years.
* Amputation Status: Unilateral major lower extremity amputation (Transtibial, Transfemoral, or Knee Disarticulation).
* Radiological Baseline: Absence of Heterotopic Ossification (HO) in the residual limb, confirmed by pre-operative X-rays (Walter Reed Classification Grade 0).
* Diagnosis: Confirmed diagnosis of "Symptomatic Neuroma" validated by the Clinical Triad:

  1. Neuropathic Pain: DN4 Questionnaire score ≥ 4.
  2. Pain Intensity: Numeric Rating Scale (NRS) score ≥ 4.
  3. Physical Exam: Positive Tinel's sign or palpation tenderness at a specific trigger point.
  4. Radiology: Diagnostic Ultrasound visualization of the neuroma bulb.
* Surgical Indication: Scheduled for RPNI surgery as part of the routine standard of care treatment protocol due to prosthesis intolerance or severe pain.
* Consent: Willing and able to provide informed consent and attend follow-up visits.

Exclusion Criteria:

* CRPS: Diagnosis of Complex Regional Pain Syndrome (CRPS Type 1 or 2).
* Concurrent Bone Surgery: Patients requiring simultaneous stump revision surgery (e.g., bone shortening, osteotomy, spur excision) or having existing HO (Walter Reed Grade \> 0).
* Systemic Conditions: Uncontrolled diabetes mellitus (HbA1c \> 8.5%) or severe peripheral arterial disease compromising wound healing.
* Cognitive Status: Cognitive impairment or psychiatric conditions preventing reliable completion of patient-reported outcome measures (PEQ, DN4).
* History: Previous RPNI surgery at the same site (Recurrent RPNI cases).

Where it's running

• University of Health Sciences, Gulhane Training and Research Hospital, Department of Orthopedics and Traumatology
  Ankara, Ankara, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Ahmet Burak Bilekli, MD, Associate Professor — University of Health Sciences, Gülhane Training and Research Hospital
• Study coordinator: Ahmet Burak Bilekli, MD, Associate Professor
• Email: draburakbilekli@yahoo.com
• Phone: +905326007020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.