Pillow Brace Assessment on Sleep Quality of Patients Undergoing Arthroscopic Rotator Cuff Surgery

NCT ID: NCT07009379

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-07-31

Brief Summary

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.

Conditions

Rotator Cuff Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pillow Brace

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

Group Type: EXPERIMENTAL

Intervention A

Intervention Type: DEVICE

Intervention A means Pillow Brace

Standard

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

Group Type: OTHER

Intervention B

Intervention Type: DEVICE

Intervention B means standard management

Interventions

Intervention A

Intervention A means Pillow Brace

Intervention Type: DEVICE

Intervention B

Intervention B means standard management

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Jouvenet

Paris, , France

Countries

France

Central Contacts

Philippe NGUYEN, MD

Role: CONTACT

philippe.nguyen.pro@gmail.com

+33 6 86 40 82 84

Facility Contacts

Philippe NGUYEN, MD

Role: primary

philippe.nguyen.pro@gmail.com

+33 6 86 40 82 84

Other Identifiers

2025-A00036-43

Identifier Type: -

Identifier Source: org_study_id