Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty: a Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Pain after surgery
研究概览
简要总结
Researchers are trying to determine if knee pain can be reduced by proactively protecting the free end of the saphenous nerve versus leaving it in the standard position during total knee arthroplasty.
详细描述
Subjects scheduled for total knee arthroplasty will be randomized to two arms. One arm will have the standard saphenous nerve neurectomy during their surgery. The other arm will have the same neurectomy procedure with the free end of the nerve tucked into soft tissue to protect the nerve ending.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary unilateral total knee arthroplasty candidate
排除标准
- •Body Mass Index (BMI) >40
- •Inflammatory arthritis
- •Unable to follow up visits (long distance from Mayo Clinic)
- •Poor compliance risk
- •Health condition deemed by physician to preclude patient's ability to participate in the trial
研究组 & 干预措施
Standard TKA
Subjects will have the standard procedure.
TKA with Neurectomy
Subjects will the nerve excised and protected with soft tissue.
干预措施: Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty (Procedure)
结局指标
主要结局
Pain after surgery
时间窗: 6 months
Self-reported pain using Visual Analog Scale which is scored using a horizontal scale from 0-10cm with 10 being the worst pain.
次要结局
未报告次要终点
研究者
Glenn G. Shi, M.D.
Principal Investigator
Mayo Clinic