Study of the Functional Result of the Reinsertion of the Subscapular in Reverse Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Mobility of internal rotation evaluation
研究概览
简要总结
This study is based on the hypothesis that the functional result is better if the subscapularis is reinserted and healed. The originality of the study therefore consists in systematically monitoring the healing of this tendon postoperatively, with sufficient follow-up, by ultrasound and by an intra-tendon marker, in order to differentiate the result depending on whether the tendon is healed or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Men or women over 18 years old
- •Patient with an indication of reverse prosthesis for cuff rupture, or eccentric omarthrosis, or omarthrosis without cuff rupture but with posterior eccentricity
- •Patient with a normal subscapularis preoperatively
- •Patient benefiting from a social protection insurance
- •Patient having signed the free and informed consent
排除标准
- •Patient with an indication of anatomical prosthesis
- •Patient with an abnormal subscapularis preoperatively
- •Patient operated for a revision of prosthesis
- •Patient with an indication for prosthesis on fracture sequelae
- •Patient with an indication for prosthesis on fracture
- •Patient participating in another clinical study
- •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
Patient with effective tendon healing
干预措施: Ultrasound (Procedure)
Patient without tendon healing
干预措施: Ultrasound (Procedure)
结局指标
主要结局
Mobility of internal rotation evaluation
时间窗: 12 months
The mobility of internal rotation will be assessed with the level of medial rotation of the Constant score (0 to 100 points - 5 different themes - 11 items)
Tendon healing assessment
时间窗: 12 months
The healing will be evaluated by an ultrasound allowing to visualize the intra tendinous marker. If this is in place, healing is effective. On the other hand, if it has migrated, there is no scarring
次要结局
未报告次要终点