Study Evaluating the Clinical Improvement Obtained by Endoscopic Tenotomy of the Ilio-Psoas, at the Level of the Lesser Trochanter Versus at the Level of the Acetabular Notch, on Psoas Cup Impingements After Total Hip Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Oxford Hip Score
研究概览
简要总结
The purpose of the study is to assess Oxford Hip Score at baseline, at 2 months and at over 12 months.
详细描述
This is an interventional, comparative, randomized study, in 2 parallel groups, single-blind (the patient does not know which technique he will benefit from, the surgeon will carry out the surgery and will therefore be informed of the result of the randomization ) and monocentric.
Comparative prospective cohort study of an endoscopic tenotomy surgery of the iliopsoas tendon at the level of the lesser trochanter versus at the level of the acetabular notch, in the context of anterior pain for impingement between the iliopsoas tendon and the prosthetic cup in patients after Total Hip Prosthesis.
The study will be proposed to the patient during the preoperative consultation. Patients eligible for surgery will be offered the study. After a reflection period of at least 15 days, patients who agree to participate in the study will be included. Randomization will be done by drawing lots to decide whether the endoscopic tenotomy will be performed at the level of the lesser trochanter or at the level of the acetabular notch. The surgery will be performed under general anesthesia with standardized multimodal analgesia. Whatever the techniques, the approaches, the instruments to perform the procedure and the postoperative course will be identical, as in usual practice.
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
- Single (Participant)
盲法说明
The patient does not know which technique he will benefit from, the surgeon will proceed with the surgery and will therefore be informed of the result of the randomization
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Definite diagnosis of iliopsoas tendinopathy due to conflict between the tendon and the prosthetic cup;
- •Failure of first-line conservative treatment;
- •Planned endoscopic tenotomy;
- •Affiliation to the social security scheme;
- •Signed informed consent.
排除标准
- •Revision total hip prosthesis, multiple operations prior to tenotomy;
- •Other surgical or medical interventions planned during the study;
- •Participation in another clinical trial, or during a period of exclusion from another clinical trial;
- •Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
- •Patient deprived of liberty or under guardianship or curatorship or unable to give consent.
结局指标
主要结局
Oxford Hip Score
时间窗: 1 year
Compare the clinical improvement experienced by patients having an endoscopic tenotomy of the iliopsoas tendon at the level of the lesser trochanter versus at the level of the notch at more than 1 year minimum. The Oxford Hip Score is a self-administered patient-administered 12-item "Patient Reported Outcome Measures" questionnaire that allows the surgeon to assess clinical outcomes after total hip replacement.
次要结局
未报告次要终点