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NCT Number: NCT07009379

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention A

Device

Intervention A means Pillow Brace

Intervention B

Device

Intervention B means standard management

Primary outcomes

  1. Sleep quality

    Time frame: Month 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe NGUYEN, MD

CONTACT

[email protected]

+33 6 86 40 82 84

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: PILLOW BRACE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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