Does the Addition of a Traction Pad Reduce the Rate of Postoperative Pudendal Neuralgia?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- patient-reported post-operative numbness
研究概览
简要总结
Compared to the knee and shoulder, the hip joint leaves relatively little space to maneuver arthroscopic instruments and camera. To expand the potential space in the hip joint, traction is commonly applied to the operative leg through a perineal post. This is an effective technique to improve the working space for arthroscopy, however it has been associated with complications, including perineal numbness. Traction pads, used alone or with a perineal post, can reduce pressure on the perineal area, thus reducing numbness. The investigators hypothesize that positioning hip arthroscopy patients using a traction pad on a standard traction table with a perineal post will reduce the incidence and duration of postoperative perineal numbness.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing hip arthroscopy
- •Ability to read and speak English
排除标准
- •Revision surgery
- •Oncologic surgery
- •Use of regional anesthesia
- •Arthroscopic hip surgery that involves procedures other than labral repair, acetabuloplasty, CAM-plasty, IT band windowing, Iliopsoas lengthening
研究组 & 干预措施
Control (No pad)
Hip arthroscopy in the usual fashion, no pad, using traction table with perineal post.
Pink Pad
Hip arthroscopy using The Pink Pad Hip Kit Patient Positioning System (Xodus Medical, New Kensington, PA). The pad is placed between the patient and the traction table, using a perineal post.
干预措施: The Pink Pad Hip Kit (Device)
结局指标
主要结局
patient-reported post-operative numbness
时间窗: 72 hours after surgery
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
patient-reported numbness
时间窗: 6 weeks after surgery
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
patient-reported post-operative numbness
时间窗: Baseline prior to surgery
Y/N Are you experiencing complete or partial numbness prior to your surgery?
patient-reported numbness
时间窗: 1 week after surgery
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
patient-reported numbness
时间窗: 3 weeks after surgery
Y/N Are you experiencing complete or partial numbness as a result of your surgery?
次要结局
- patient-reported difficulty with bowel movements(6 weeks after surgery)
- patient-reported skin changes or breakdown(6 weeks after surgery)
- patient-reported difficulty urinating(6 weeks after surgery)
- patient-reported sexual disfunction or erectile disfunction(6 weeks after surgery)
- patient-reported difficulty urinating(Baseline prior to surgery)
- patient-reported difficulty urinating(72 hours after surgery)
- patient-reported difficulty urinating(1 week after surgery)
- patient-reported difficulty urinating(3 weeks after surgery)
- patient-reported difficulty with bowel movements(Baseline prior to surgery)
- patient-reported difficulty with bowel movements(72 hours after surgery)
- patient-reported difficulty with bowel movements(1 week after surgery)
- patient-reported difficulty with bowel movements(3 weeks after surgery)
- patient-reported skin changes or breakdown(Baseline prior to surgery)
- patient-reported skin changes or breakdown(72 hours after surgery)
- patient-reported skin changes or breakdown(1 week after surgery)
- patient-reported skin changes or breakdown(3 weeks after surgery)
- patient-reported sexual disfunction or erectile disfunction(Baseline prior to surgery)
- patient-reported sexual disfunction or erectile disfunction(72 hours after surgery)
- patient-reported sexual disfunction or erectile disfunction(1 week after surgery)
- patient-reported sexual disfunction or erectile disfunction(3 weeks after surgery)
研究者
Vehniah Tjong
Assistant Professor of Orthopaedic Surgery
Northwestern University