NCT07420192 Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees
| NCT ID | NCT07420192 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Saglik Bilimleri Universitesi |
| Condition | Symptomatic Neuroma |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-01-20 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Ahmet Burak Bilekli, MD, Associate Professor
PRINCIPAL INVESTIGATOR
University of Health Sciences, Gülhane Training and Research Hospital
Frequently Asked Questions
Who can join the NCT07420192 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Symptomatic Neuroma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07420192 currently recruiting?
Yes, NCT07420192 is actively recruiting participants. Contact the research team at draburakbilekli@yahoo.com for enrollment information.
Where is the NCT07420192 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07420192 clinical trial?
NCT07420192 is sponsored by Saglik Bilimleri Universitesi. The principal investigator is Ahmet Burak Bilekli, MD, Associate Professor at University of Health Sciences, Gülhane Training and Research Hospital. The trial plans to enroll 20 participants.