Pillow Brace Assessment on Sleep Quality of Patients Undergoing Arthroscopic Rotator Cuff Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sleep quality
研究概览
简要总结
Rotator cuff surgery is an increasingly popular procedure in France. It is a common procedure for patients with shoulder tendon injuries, aimed at restoring mobility and reducing pain. Although arthroscopic techniques have improved functional outcomes, managing postoperative pain, particularly at night, and its consequences remains a major challenge.
Studies highlight that postoperative nighttime pain can significantly affect sleep quality, delaying functional recovery and patient satisfaction. However, standard splints used for postoperative immobilization do not offer an optimal solution to this problem, leaving a significant gap in the care of these patients.
Given this observation, a splint incorporating a support cushion system could meet the specific needs expressed by patients who have undergone rotator cuff surgery, namely improving sleep quality by minimizing nighttime pain. This splint, called the "Pillow Brace," was developed internally at the Jouvenet Clinic. It therefore does not have CE marking.
Nevertheless, this study is based on the hypothesis that the use of a "Pillow Brace" could significantly improve sleep quality compared to standard splints, thus making a significant contribution to orthopedic medicine, postoperative rehabilitation, and patient quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patient undergoing arthroscopic rotator cuff repair surgery confirmed by clinical diagnosis and preoperative imaging tests.
- •Patient able to understand the instructions for using the brace.
- •Patient able to perform activities of daily living with or without a brace, ensuring proper use of the brace.
- •Patient affiliated with or beneficiary of a social security system
- •French speaking patient, having signed an informed consent form
排除标准
- •Patient with an uncertain diagnosis
- •Patient undergoing rotator cuff revision surgery.
- •Patient with complex or surgical fractures of the shoulder, humerus, or ribs
- •Patient with multiple fractures, open fractures, or those with pinning
- •Patient who has undergone multiple surgeries in the last 6 months.
- •Patient with shoulder pathologies unrelated to the rotator cuff, such as severe arthritis or capsulitis.
- •Patient on long-term morphine treatment
- •Patient with known allergies to splint materials
- •Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative order
- •Pregnant woman
- •Patient hospitalized without consent
- •Patient already enrolled and participating in another clinical study
研究组 & 干预措施
Standard
The "Standard" arm will consist of a Dujarrier-type splint
干预措施: Intervention B (Device)
Pillow Brace
The "Pillow Brace" arm will consist of a Dujarrier-type splint to which a deformable cushion will be fixed
干预措施: Intervention A (Device)
结局指标
主要结局
Sleep quality
时间窗: Month 1
Sleep quality will be assessed using PSQI (Pittsburg Sleep Qulity Index). Score is from 0 to 21. 0 means no sleel problems whereas 21 means major sleep problems.
次要结局
未报告次要终点