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
- 22
- 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
- 未提供
排除标准
- 未提供
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)