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Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees

Recruitingn/aAges 18 Years - 70 YearsAllSaglik Bilimleri Universitesi
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 4. 2. Pain Intensity: Numeric Rating Scale (NRS) score โ‰ฅ 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).
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What it tests

  • Regenerative Peripheral Nerve Interface (RPNI) Surgery
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Where

1 site
University of Health Sciences, Gulhane Training and Research Hospital, Department of Orthopedics and Traumatology
Ankara, Turkey (Tรผrkiye)
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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