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

NCT07009379 | Not Yet Recruiting

• 1 other identifier: 2025-A00036-43
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 1

Study Arms (2)

Pillow Brace

EXPERIMENTAL

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

Device: Intervention A

Standard

OTHER

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

Device: Intervention B

Interventions

Intervention A DEVICE

Intervention A means Pillow Brace

Pillow Brace

Intervention B DEVICE

Intervention B means standard management

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique Jouvenet

Paris, 75016, France

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Philippe NGUYEN, MD

CONTACT

+33 6 86 40 82 84; philippe.nguyen.pro@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

FR (1)