Actively Recruiting
Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees
Led by Saglik Bilimleri Universitesi · Updated on 2026-02-19
20
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Unilateral major lower extremity amputation (Transtibial, Transfemoral, or Knee Disarticulation)
- No heterotopic ossification in the residual limb confirmed by pre-operative X-rays
- Confirmed symptomatic neuroma diagnosis validated by neuropathic pain questionnaire, pain intensity scale, physical exam, and ultrasound
- Scheduled for RPNI surgery due to prosthesis intolerance or severe pain
- Able to provide informed consent and attend follow-up visits
You will not qualify if you...
- Diagnosis of Complex Regional Pain Syndrome (CRPS Type 1 or 2)
- Need for simultaneous stump revision bone surgery or presence of heterotopic ossification (Walter Reed Grade > 0)
- Uncontrolled diabetes mellitus (HbA1c > 8.5%) or severe peripheral arterial disease
- Cognitive or psychiatric conditions preventing reliable completion of patient-reported outcome measures
- Previous RPNI surgery at the same site
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Health Sciences, Gulhane Training and Research Hospital, Department of Orthopedics and Traumatology
Ankara, Ankara, Turkey (Türkiye), 06018
Actively Recruiting
Research Team
A
Ahmet Burak Bilekli, MD, Associate Professor
CONTACT
M
Muhammed Burak Polat, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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