Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07420192
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07420192
Study Brief:
Protocol Section:
NCT07420192