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NCT07009379: PILLOW BRACE

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

Not yet recruiting NA Last updated 29 September 2025
What this trial tests

NA trial testing Intervention A in Rotator Cuff Injury in 100 participants. Not yet recruiting.

Timeline
1 October 2025
Primary endpoint
31 July 2027
31 July 2027

Quick facts

Lead sponsorGCS Ramsay Santé pour l'Enseignement et la Recherche
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment100
Start date1 October 2025
Primary completion31 July 2027
Estimated completion31 July 2027
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche — full company profile →

Who can join

18 and older, any sex, with Rotator Cuff Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Intervention A

Trials testing the same drug.

Other recruiting trials for Rotator Cuff Injury

Currently open trials in the same condition.

Other GCS Ramsay Santé pour l'Enseignement et la Recherche trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07009379.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing