NCT01893034Unknown不适用
A Randomised Controlled Trial of Surgical Versus Non-surgical Treatment of Femoroacetabular Impingement
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Hip Outcome Score
研究概览
简要总结
Femoroacetabular Impingement (FAI) describes a condition of the hip where additional bone results in the abutment of the femoral neck against the rim of the acetabulum. This gives rise to localised cartilage damage and pain, but also increases the risk of developing osteoarthritis. The purpose of this study is to compare the effectiveness of arthroscopic surgery versus physiotherapy and activity modification for the treatment of this condition.
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
- •Symptomatic patients
- •Age 18-60 years
- •Clinical and radiological evidence of FAI
- •Competent to consent
排除标准
- •Prior hip surgery
- •Established osteoarthritis (Kellgren-Lawrence >/= 2)
- •Hip dysplasia (Centre-Edge angle < 20 degrees on radiograph)
- •Completion of physiotherapy programme targeting FAI within past year
- •Co-morbidities that mean surgical intervention is not possible/safe
- •Contraindication to MRI
- •Pregnancy
结局指标
主要结局
Hip Outcome Score
时间窗: 8 months post randomisation (approximately 6 months post intervention)
Hip Outcome Score is a patient reported outcome measure
次要结局
- Hip Radiographs(Regular intervals up to 38 months post randomisation (approximately 3 years post intervention))
- Patient Reported Outcome Measures(Regular intervals up to 38 months post randomisation (approximately 3 years post intervention))
- Morphological and Physiological MRI(Regular intervals up to 38 months post randomisation (approximately 3 years post intervention))
- Clinical Examination(Regular intervals up to 38 months post randomisation (approximately 3 years post intervention))
- Serum and Urinary Biomarkers of Osteoarthritis(Regular intervals up to 38 months post randomisation (approximately 3 years post intervention))
研究者
研究点 (4)
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