NCT03158454进行中（未招募）不适用
Capsula Closure Versus Non-Capsula Closure During Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年6月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in patient reported outcome scores (Hagos)
研究概览
简要总结
The purpose of this study is to investigate whether patients undergoing surgical treatment (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of higher scores in validated patient reported outcome measurements, compared to a Group of patients with FAI syndrome where the capsule is left open at the end of the surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiological and symptomatic Femoroacetabular Impingement, where surgery is indicated. Preoperatively a minimum of 3 months of relevant physiotherapeutic treatment should have been performed.
排除标准
- •Previous hip surgery in either hip
- •Malignant disease
- •Recent hip or pelvic fractures
- •Arthritic disease
- •Hip joint dysplasia
- •Legg-Calvé-Perthes
- •Slipped Capital Femoris Epiphysis
- •Recent (within 6 weeks) medical treatment with corticosteroids
- •Language problems of any kind
结局指标
主要结局
Change in patient reported outcome scores (Hagos)
时间窗: From baseline to 2 year after the operation
Copenhagen Hip and Groin Outcome Score - Questionnaire - Hip-function Score (0-100)
次要结局
- Change in patient reported outcome scores (EQ5D(From baseline to 2 year after the operation)
- Change in patient reported outcome scores (NRS)(From baseline to 2 year after the operation)
- Change in patient reported outcome scores (Ihot12)(From baseline to 2 year after the operation)
- Reoperation(Up to 2 years after surgery)
研究者
Martin Lind
Professor
Aarhus University Hospital
研究点 (2)
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