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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intervention A

    Device

    Intervention A means Pillow Brace

  • Intervention B

    Device

    Intervention B means standard management

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Pillow BraceExperimental treatment 1 intervention
Group B: StandardOther 1 intervention

Trial outcomes

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.

Time frame
Month 1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.