Clinical trial NCT07009379: Pillow Brace Assessment on Sleep Quality of Patients Undergoing Arthroscopic Rotator Cuff Surgery
Official title: Pillow Brace Assessment on Sleep Quality of Patients Undergoing Arthroscopic Rotator Cuff Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Injury
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Sleep quality
timeFrame: Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Jouvenet
Study officials:
References: