[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625250":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":56,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":73,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":82,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Saglik Bilimleri Universitesi","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RPNI Group",null,"Adult patients (18-70 years) with unilateral major lower extremity amputations (transtibial or transfemoral) who are diagnosed with \"Symptomatic Neuroma\" confirmed by the clinical triad (DN4 score ≥4, positive Tinel sign, and diagnostic ultrasound). These patients are scheduled to undergo Regenerative Peripheral Nerve Interface (RPNI) surgery as part of the routine standard of care treatment protocol.",[13],"Procedure: Regenerative Peripheral Nerve Interface (RPNI) Surgery",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Regenerative Peripheral Nerve Interface (RPNI) Surgery","The surgical procedure is standardized as follows to preserve the residual limb (stump) anatomy:\n\n* 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.\n* 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.\n* 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.\n* 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.",[9],[21],{"name":22,"affiliation":23,"role":24},"Ahmet Burak Bilekli, MD, Associate Professor","University of Health Sciences, Gülhane Training and Research Hospital","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+905326007020","draburakbilekli@yahoo.com",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":29},"Muhammed Burak Polat, MD","+90 545 340 73 23",[34],{"facility":35,"status":36,"city":37,"state":37,"zip":38,"country":39,"countryCode":10,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"University of Health Sciences, Gulhane Training and Research Hospital, Department of Orthopedics and Traumatology","RECRUITING","Ankara","06018","Turkey (Türkiye)",{"type":41,"coordinates":42},"Point",[43,44],32.85427,39.91987,{"lat":44,"lon":43},[47,49,51,52,54],{"name":22,"role":27,"phone":48,"phoneExt":10,"email":29},"05326007020",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":50},"burakp1512@gmail.com",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":31,"role":53,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":55,"role":53,"phone":10,"phoneExt":10,"email":10},"Hasan Dönmez, MD",{"type":24,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ahmet Burak Bilekli","Associate Professor","100625250","evaluation-of-rpni-for-symptomatic-neuromas-in-lower-limb-amputees-100625250",false,"NCT07420192","Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees","The Effect of Regenerative Peripheral Nerve Interface (RPNI) Surgery on Neuropathic Pain and Functional Outcomes in Major Lower Extremity Amputations","RPNI-AMPUTEE","Inclusion Criteria:\n\n* Age: Adults aged 18 to 70 years.\n* Amputation Status: Unilateral major lower extremity amputation (Transtibial, Transfemoral, or Knee Disarticulation).\n* Radiological Baseline: Absence of Heterotopic Ossification (HO) in the residual limb, confirmed by pre-operative X-rays (Walter Reed Classification Grade 0).\n* Diagnosis: Confirmed diagnosis of \"Symptomatic Neuroma\" validated by the Clinical Triad:\n\n  1. Neuropathic Pain: DN4 Questionnaire score ≥ 4.\n  2. Pain Intensity: Numeric Rating Scale (NRS) score ≥ 4.\n  3. Physical Exam: Positive Tinel's sign or palpation tenderness at a specific trigger point.\n  4. Radiology: Diagnostic Ultrasound visualization of the neuroma bulb.\n* Surgical Indication: Scheduled for RPNI surgery as part of the routine standard of care treatment protocol due to prosthesis intolerance or severe pain.\n* Consent: Willing and able to provide informed consent and attend follow-up visits.\n\nExclusion Criteria:\n\n* CRPS: Diagnosis of Complex Regional Pain Syndrome (CRPS Type 1 or 2).\n* Concurrent Bone Surgery: Patients requiring simultaneous stump revision surgery (e.g., bone shortening, osteotomy, spur excision) or having existing HO (Walter Reed Grade \\> 0).\n* Systemic Conditions: Uncontrolled diabetes mellitus (HbA1c \\> 8.5%) or severe peripheral arterial disease compromising wound healing.\n* Cognitive Status: Cognitive impairment or psychiatric conditions preventing reliable completion of patient-reported outcome measures (PEQ, DN4).\n* History: Previous RPNI surgery at the same site (Recurrent RPNI cases).","ALL","18 Years","70 Years",{"count":71,"type":72},20,"ESTIMATED","24 Months","OBSERVATIONAL","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.",[77,78,79,80,81],"Symptomatic Neuroma","Phantom Limb Pain After Amputation","Residual Limb Pain","Neuropathic Pain","Lower Extremity Amputations",[83,84,85,86,87,88,89,90],"RPNI","Regenerative Peripheral Nerve Interface","Pressure Pain Threshold","PPT","Algometry","Prosthesis Satisfaction","Viscero-Somatic Convergence","Phantom Motor Execution","2026-02-12",{"date":93,"type":94},"2026-02-19","ACTUAL",{"date":96,"type":94},"2026-01-20",{"date":98,"type":72},"2030-03",{"name":5,"class":6},1]