Prospective, Multicenter, Randomized Single-blind Study on the Interest of Capsular Repair in the Latarjet Operation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- occurrence of osteoarthritis
研究概览
简要总结
The purpose of the study is to evaluate the occurrence of osteoarthritis (YES/NO) by radiography.
详细描述
This is a prospective, comparative, longitudinal, randomized, single-blind, multicenter study.
This study will validate preliminary results on a technique associating capsular repair with abutment according to Latarjet in the treatment of shoulder instabilities. It may help reduce the risk of osteoarthritis and thus allow patients to maintain a healthy, stable and painless shoulder for longer.
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
randomized single-blind study
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
- •Patient, male or female, over the age of 18
- •Patient with shoulder instability with risk factors for recurrence (ISIS score > 3), requiring surgical stabilization by abutment
- •Affiliated patient or beneficiary of a social security scheme
- •Patient having been informed and having given his free, informed and written consent.
排除标准
- •Patient with history of surgery for instability of the same shoulder
- •Patient presenting contraindications to the realization of a postoperative scanner
- •Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant
- •Patient participating in another clinical research or in a period of exclusion from another research still in progress at the time of inclusion
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- •Pregnant, breastfeeding or parturient woman
- •Patient hospitalized without consent.
研究组 & 干预措施
With capsular repair
This technique consists of inserting the capsule during the operation according to Latarjet.
干预措施: Latarjet technique (Procedure)
Without capsular repair
Latarjet technique without capsular repair
干预措施: Latarjet technique (Procedure)
结局指标
主要结局
occurrence of osteoarthritis
时间窗: 10 years
Change from occurrence of osteoarthritis (YES/NO) on X-ray at 5 and 10 years, compared to inclusion X-ray using the Samilson-Prieto classification.
次要结局
未报告次要终点