NCT04702139已完成不适用
Use of the "Game-Ready" Splint for Better Recovery in Primary Total Shoulder Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- the level of postoperative pain following the installation of the Game Ready
研究概览
简要总结
The aim of the study is to compare the level of postoperative pain after fitting the Game Ready splint, at 48 hours versus that observed with fitting a standard splint
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
- 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
- •First-line reverse prosthesis
- •Without prosthetic history
- •Patient who has given his consent to participate in the observational study after being informed by the surgeon
- •Patient living in France and able to answer the questionnaire alone.
- •Subject affiliated to a social security scheme or beneficiary of such a scheme
- •Lack of participation in another clinical study
排除标准
- •Minor patient
- •Major subject protected by law, under curatorship or tutorship
- •Anterior prosthesis
- •Parkinson's, degenerative neurological disease
- •Pregnant or breastfeeding woman
研究组 & 干预措施
patient with game-ready splint
Active Comparator
Installation of the Game-Ready splint immediately after surgery for 12 hours. They will then be put on the standard splint which they will keep for 2 weeks as for the other group but without ice packs.
干预措施: shoulder arthroplastis (Device)
patient with standard splint
Placebo Comparator
Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days.
干预措施: shoulder arthroplastis (Device)
结局指标
主要结局
the level of postoperative pain following the installation of the Game Ready
时间窗: 9 months
Visual Analog Score for pain
次要结局
- risk of stiffness(up to 9 months)
- occurrence of hematoma, edema(up to 9 months)
- length of hospitalization(up to 24 hours)
- the time limit for returning to a possible professional activity(up to 3 months)
- evolution of mobility(up to 9 months)
研究者
研究点 (2)
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