Treatment of Chronic Anterior Shoulder Instability by a Latarjet-type Bone Block Procedure Using the SEM (Science Et Medecine) Positioning Tool: Using a Scan to Assess Consolidation and Return to Normal Activity at 3 Months
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Did the patient return to activity at 3 months? yes/no
研究概览
简要总结
The main objective of this study is to evaluate, after surgery for chronic anterior shoulder instability using a Latarjet technique with positioning of the bone block via an SEM positioning tool, the value of the contribution of a shoulder scan at 3 months post surgery in the decision to return to activity early as conditioned by the quality of the bone block consolidation.
详细描述
The secondary objectives of this study are to assess:
A. the position of the block according to a shoulder scan at 3 months post-surgery
B. functional scores (Constant, Walch-Duplay) at 6 weeks, 3 and 6 months post surgery.
C. Complications: osteoarthritis, lysis of the block.
D. pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient was operated for chronic anterior shoulder instability (defined by a history of at least two true dislocations and an ISIS score> 2) 6 weeks ago (+/- 5 days)
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
结局指标
主要结局
Did the patient return to activity at 3 months? yes/no
时间窗: Week 6 after inclusion, which = 3 months after surgery
次要结局
- Walch-Duplay score(week 18)
- Constant score(week 18)
- Date of return to total activity(week 18)
- Presence/absence of complications(week 18)
- Visual analog scale for pain(week 18)
- Visual analog scale for satisfaction(week 18)