Clinique Jouvenet
Paris, 75016, France
Location contact
Philippe NGUYEN, MD
CONTACT
Philippe NGUYEN, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07009379
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Paris, 75016, France
Philippe NGUYEN, MD
CONTACT
Philippe NGUYEN, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention A means Pillow Brace
Intervention B means standard management
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.
Contact information is provided by the study sponsor or research team.
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
Acronym: PILLOW BRACE
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.
Published trials that share one or more normalized conditions with this study.
NCT07659600
Arthralgia, Joint Diseases
View Trial DetailsNCT07376811
Arthralgia, Dyssomnias
São Caetano do Sul, São Paulo, Brazil
View Trial DetailsNCT06945926
Bone Diseases, Cervical Spinal Stenosis
Hangzhou, Zhejiang, China
View Trial DetailsNCT06924112
Rotator Cuff Injuries, Rotator Cuff Injury
Temuco, Cautín, Chile
View Trial Details