Prospective Study, Monocentric, Randomized, Double Blind Evaluating the Non Inferiority of Non Capsular Suture in Arthroscopic Treatment of Cam or Mixed-type Femoroacetabular Impingement Without Hip Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- patient reported outcomes (questionnaires)
研究概览
简要总结
Since last past decade, arthroscopic hip surgery proved its efficacy in femoroacetabular impingement treatment. However, no consensus exist concerning capsular suture or not. According to capsular incision size, articular instability can persist if no suture is performed. In contrast, tightly suture can cause post-operative joint stiffness.
This study aims to evaluate the non inferiority of non capsular suture after hip arthroscopy treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up.
详细描述
Main Objective :
Non inferiority evaluation of non capsular suture after hip arthroscopy treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up.
The primary study endpoint is the patient reported outcomes (HAGOS score; iHOT-12 and MHHS) at 2 years follow-up.
Secundary objectives :
- Clinical results at 6 month and 1 year follow-up
- Specific complications occuring and frequences
- Patient quality of life,
- The return to sport,
- Sport level after surgery compare to sport level before surgery
- Pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient < 18 years old
- •Patient who can be followed for 2 years
- •Patient with confirmed diagnostic of femoroacetabular impingement came or mixed-types, without dysplasia and with VCE angle > 25°, without prearthrosic lesion and Tonnis 0 ou Tonnis 1, radiographic assement
- •Patient must sign an informed consent form indicating that he or she understands the purpose of procedure required for the study and accepts to participate in the study.
- •Patient affiliated to a social security system
排除标准
- •Patient with no wittren informed consent
- •Patient presenting osteoarthritis (Tonnis stage 2) or only pincer impingement
- •Hyperlaxity
- •Dysplasia (VCE <25°)
- •Patient already underwent hip arthroscopy
- •Patient already underwent previous hip surgery
- •Patient needing bilateral hip arthroscopy < 2 years
- •Persons deprived of their freedom or under guardianship or incapable of giving consent
研究组 & 干预措施
Capsular suture
Capsular suture at the end of hip arthroscopy
干预措施: Hip arthroscopy (Procedure)
No capsular suture
No capsular suture at the end of hip arthroscopy
干预措施: Hip arthroscopy (Procedure)
结局指标
主要结局
patient reported outcomes (questionnaires)
时间窗: 2 years
HAGOS score
次要结局
- patient reported outcomes (questionnaires)(1 year)
- patient reported outcomes (questionnaires)(6 months)