A Randomized Controlled Trial Comparing Arthroscopic Surgery to Conservative Management of Femoroacetabular Impingement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Hip Outcome Score (HOS)
研究概览
简要总结
The objective of this study is to determine if patients with femoroacetabular impingement (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years post-operative with respect to physical function, pain, and health related quality of life, compared to similar patients who receive conservative management, including medication and physiotherapy.
详细描述
Arthroscopic surgery is now commonly used to treat patients with femoroacetabular impingement (FAI) however there is a lack of scientific evidence to support its efficacy. Two distinct types of FAI have been defined: cam impingement and pincer impingement. Cam impingement is described as an abnormally prominent anterolateral femoral head-neck junction that rubs against the acetabular rim during flexion resulting in impingement of the acetabular labrum. Pincer impingement is described as an anatomical overcoverage of the femoral head by the acetabulum that impinges the labrum leading to proliferation, or an increase in the prominence of the acetabular rim, further exacerbating the impingement. Previous studies investigating the efficacy of arthroscopic surgery of the knee and shoulder have shown no benefit compared to sham surgery and non-surgical management, therefore strong scientific evidence is needed to support its use in the treatment of hip pathology.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with femoroacetabular impingement of the hip
- •18 years of age or older
- •grade 1, 2 or 3 radiographic severity of osteoarthritis as defined by the Tonnis classification scale.
排除标准
- •identified isolated labral tear
- •inflammatory or post-infectious arthritis
- •previous arthroscopic treatment for hip osteoarthritis
- •previous major hip trauma
- •Tönnis grade 4 osteoarthritis in two compartments in persons over 60 years of age.
- •patients with a major neurologic deficit, serious medical illness (life expectancy less than 2 years or high intraoperative risk) or those who are unable to provide informed consent or who are deemed unlikely to comply with follow-up.
结局指标
主要结局
Hip Outcome Score (HOS)
时间窗: 24 months
The HOS is a disease-specific questionnaire with high reliability and internal consistency. The index has 2 subscales: Activities of Daily Living (ADL) and Sports. Items are scored from 0-4, or N/A which removes item from scoring. The highest potential score is the total number of items with a response multiplied by 4. The item score divided by the highest potential score, multiplied by 100, generates a percentage. A higher score represents a higher level of physical function. The minimal clinically important difference is 9 points for the ADL subscale and 6 points for the Sports subscale.
次要结局
- Non-Arthritic Hip Score(2 weeks, and at months 3, 6, 12, 18, and 24.)
- Modified Harris Hip Score(2 weeks, and at months 3, 6, 12, 18, and 24.)
- SF-12(2 weeks, and at months 3, 6, 12, 18, and 24.)
- Range of Motion(2 weeks, and at months 3, 6, 12, 18, and 24.)