Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction During Hip Arthroscopic Procedures Clinical Protocol: Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intra-operative application of hip distraction without a perineal post to the lower extremity during hip arthroscopy procedures.
研究概览
简要总结
The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury.
详细描述
The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury. The data from this exploratory study can be used to help develop estimates of the proportions of patients who experience significant venous/nerve/tissue compromise in the lower extremity as a result of the application of traction forces necessary to achieve hip joint distraction, and may serve as a basis for sample size planning in future studies comparing the effects of various methods of hip distraction techniques during hip arthroscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18 and 65 years of age inclusively
- •Has elected to undergo a standard hip arthroscopic procedure that is expected to require access to the central compartment of the hip joint (bilateral hip enrollment is allowed)
- •Is able to give voluntary, written informed consent to participate in this clinical investigation and has signed an informed consent document
排除标准
- •Any major systemic or lower extremity trauma, or any preexisting medical condition/illness that represents a contraindication for hip arthroscopy surgery
- •Significant peripheral vascular disease characterized by diminished dorsalis pedis or tibial pulse
- •Significant peripheral neuropathy demonstrated by nerve conduction velocity test
- •Preoperative use of statins or other medications known to elevate serum CPK-MM levels within one week of surgery
- •Total hip replacement of the indicated hip(s)
- •History of substance abuse within past 12 months (this includes any chronic narcotic use)
- •Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the informed consent process
结局指标
主要结局
Intra-operative application of hip distraction without a perineal post to the lower extremity during hip arthroscopy procedures.
时间窗: 12 Days
Routine intra-operative application of hip distraction without a perineal post to the lower extremity during hip arthroscopy procedures will result in significant blood flow alterations as measured by Doppler ultrasonography.
次要结局
- Estimate the amount of tissue/muscle damage associated with hip arthroscopy procedures.(12 Days)
- Blood Flow Alterations(12 Days)
- Pre- and post-operative screening for DVT.(12 Days)