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

Launched by GCS RAMSAY SANTÉ POUR L'ENSEIGNEMENT ET LA RECHERCHE · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of splint called the "Pillow Brace," which is designed to help patients who have undergone arthroscopic rotator cuff surgery. The goal of the study is to see if this special brace can improve sleep quality by reducing nighttime pain after surgery. Many patients experience discomfort at night after their surgery, which can make it hard for them to sleep and can slow down their recovery. The trial aims to find out if using the Pillow Brace makes a significant difference compared to standard splints.

To participate in this trial, patients must be between 65 and 74 years old and have been diagnosed with a rotator cuff injury that requires surgery. They should be able to understand how to use the brace and perform daily activities with or without it. It's important to note that this study is not yet recruiting participants. If you or a loved one are considering joining, you should be aware that those with certain conditions, like complicated shoulder injuries or multiple recent surgeries, will not be eligible. This trial is an exciting opportunity to potentially improve the recovery experience for patients undergoing rotator cuff surgery.

Gender

ALL

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