Pillow Brace Assessment on Sleep Quality of Patients Undergoing Arthroscopic Rotator Cuff Surgery (PILLOW BRACE)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Not yet enrolling

Conditions: Rotator Cuff Injury

Treatments: Device: Intervention A; Device: Intervention B

Study type: Interventional

Funder types: Other

Identifiers

NCT07009379

2025-A00036-43

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pillow Brace

Experimental group

Description:

The "Pillow Brace" arm will consist of a Dujarrier-type splint to which a deformable cushion will be fixed

Treatment:

Device: Intervention A

Standard

Other group

Description:

The "Standard" arm will consist of a Dujarrier-type splint

Treatment:

Device: Intervention B