A Multicenter, Prospective, Randomized and Subject Blinded Comparative Study of AxoGuard® Nerve Cap and Neurectomy for the Treatment of Symptomatic Neuroma and Prevention of Recurrent End-Neuroma Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 11
- 主要终点
- Change in Visual Analog Scale (VAS) For Pain Score at 12 Post-operative Months in Comparative Phase Subjects
研究概览
简要总结
Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot or ankle. Study consists of 86 subjects randomized between the treatment groups followed for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Potential Subjects must):
- •Be able and willing to provide documented informed consent prior to the conduct of any study procedures;
- •Be an adult male or non-pregnant female ≥ 18 years of age;
- •Report baseline pain scores of >65mm on a 100mm Visual Analog Scale (VAS) at screening;
- •Have a documented diagnosis of symptomatic neuroma of at least one interdigital nerve in the foot which cannot be repaired to a distal nerve end;
- •Must have the of the following:
- •Pain with at least 3 of the following characteristics: burning, sharp, shooting, electric, parasthesias, numbness, cold intolerance;
- •Symptoms in a defined neural anatomic distribution
- •History of nerve injury or suspected nerve injury
- •Must have at least 1:
- •Positive response to local anesthetic injection
- •US or MRI confirmation of neuroma
- •Be candidates indicated for surgery to address a symptomatic neuroma;
- •Have sufficient healthy soft tissue available to adequately cover the Axoguard® Nerve Cap;
- •In the surgeon's opinion, be likely to achieve complete resection of the symptomatic neuroma and be able to undergo implantation with the Axoguard® Nerve Cap or complete the neurotomy procedure in the control group;
- •Be willing and able to comply with all aspects of the treatment and evaluation schedule over a 12-month duration.
排除标准
- •(Potential Subjects must not):
- •Have undergone surgical treatment of pain from symptomatic neuroma in the target nerve(s)on three or more occasions;
- •Have biomechanical pathology and associated pain (such as plantar fasciitis, bursitis, sesamoid bone pain, tendinitis, etc);
- •Have a life expectancy of less than 12 months;
- •Have a history of or planned radiotherapy in the area of the end-neuroma;
- •be contraindicated for soft tissue implants.; this includes but is not limited to any pathology that would limit the blood supply; compromise healing or indicate the presence of a local infection;
- •Have a history of chronic ischemic conditions of the extremity;
- •Have a diagnosis of type 1 Diabetes Mellitus; or uncontrolled Type 2 Diabetes Mellitus (at the discretion of the investigator);
- •Have a history of diabetic neuropathy;
- •Be undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system;
- •Be immunosuppressed, immunocompromised or have planned immunosuppressive therapy within 12 months following the study procedure;
- •Have a History of congenital neuropathy or compressive neuropathy affecting the target limb;
- •Have a history of prior surgical management of more proximal compressive neuropathies or spinal conditions (e.g. spinal stenosis) not related to the symptomatic neuroma that affect the target limb;
- •Currently use or likely need to use medication during the study known to impact nerve regeneration or to cause peripheral neuropathy;
- •Be pregnant or plan to become pregnant during the duration of the study;
- •Be or have been enrolled in another interventional study within 30 days prior to consenting;
- •Have a known allergy to anesthetic agents;
- •Have a known sensitivity to porcine derived materials; or
- •Be, in the opinion of the Investigator, unsuitable for inclusion in the study.
研究组 & 干预措施
AxoGuard® Nerve Cap
Porcine derived extracellular matrix (ECM) based Nerve Termination Device.
Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.
干预措施: AxoGuard® Nerve Cap (Device)
Standard Neurectomy
Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).
干预措施: Standard Neurectomy (Procedure)
结局指标
主要结局
Change in Visual Analog Scale (VAS) For Pain Score at 12 Post-operative Months in Comparative Phase Subjects
时间窗: 12 months
The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10-centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the participant is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing "no pain" and 100 millimeters representing "the worst pain imaginable".
The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 3 Months
时间窗: 3 months
The primary safety endpoint will compare the rate of SAEs related to the procedure or device between treatment groups. The rate of serious adverse events for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.
The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 3 Months
时间窗: 3 months
The primary safety endpoint will compare the rate of procedure- or device-related AEs or UADEs between treatment groups. The rate of events or effects for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.
次要结局
- The Change From Baseline of Patient Reported Outcome Measurement Information System (PROMIS®) Pain Behavior Scale Score at Month 12(12 months)
- Change in Foot Health Status Questionnaire (FHSQ) General Foot Health Scale at 12 Post-operative Months Compared to Baseline.(12 months)
- As-Prescribed Opioid Medication(12 Months)
- As-Taken Medication(12 Months)
- Rate of Recurrence of Symptomatic Neuroma(12 Months)
- Total Reported Pain From Baseline to 12 Months(12 Months)
- The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 6 Months(6 Months)
- The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 6 Months(6 Months)
- The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 9 Months(9 Months)
- The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 9 Months(9 Months)
- The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 12 Months(12 Months)
- The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 12 Months(12 Months)