[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"symptomatic-neuroma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:symptomatic-neuroma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"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":21,"type":22},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.",[27,28,29,30,31],"Symptomatic Neuroma","Phantom Limb Pain After Amputation","Residual Limb Pain","Neuropathic Pain","Lower Extremity Amputations",[33,34,35,36,37,38,39,40],"RPNI","Regenerative Peripheral Nerve Interface","Pressure Pain Threshold","PPT","Algometry","Prosthesis Satisfaction","Viscero-Somatic Convergence","Phantom Motor Execution","RECRUITING","2026-02-12",{"date":44,"type":45},"2026-02-19","ACTUAL",{"date":47,"type":45},"2026-01-20",{"date":49,"type":22},"2030-03",{"name":51,"class":52},"Saglik Bilimleri Universitesi","OTHER"]