About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Intervention A
DeviceIntervention A means Pillow Brace
Intervention B
DeviceIntervention B means standard management
Treatment groups
Trial outcomes
Primary outcomes
Sleep quality
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.
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