180
Participants
Start Date
December 31, 2016
Primary Completion Date
January 31, 2025
Study Completion Date
January 31, 2025
Placebo surgery and supervised specific exercises
The patient is prepared for surgery as normal (plexus+general anesthesia or TIVA, with antibiotic prophylaxis). The arthroscope is introduced in the glenohumeral joint, and thereafter online randomization is performed. The joint space is evaluated. Nothing is to be removed or excised and the use of any vapour or shaver device is not allowed. The presence of a full-thickness rotator cuff tear is verified. Altogether 3 to 5 small stab wounds are made in typical locations resembling locations of typical rotator cuff repair. The time spent in the operating theatre with patients in placebo group should resemble the time spent with patients in the active treatment group and hence give an impression of a rotator cuff repair.
Rotator cuff repair and supervised specific exercises
The patient is prepared for surgery as normal (plexus+general anesthesia or TIVA, with antibiotic prophylaxis). The arthroscope is introduced in the glenohumeral joint, and thereafter online randomization is performed. The joint space is evaluated and the presence of a full-thickness rotator cuff tear is verified. The cuff tear is repaired to its anatomic location using suture anchors according to surgeon preference. . A biceps tenotomy or tenodesis may be performed according to surgeon preference if the biceps tendon is noted to be frayed, unstable or inflamed. An additional acromioplasty may be performed according to surgeon preference.
Helsinki University Hospital, Helsinki
Central Finland Central Hospital, Jyväskylä
Kuopio University Hospital, Kuopio
Oulu University Hospital, Oulu
Satakunta Central Hospital, Pori
Hatanpää Hospital, Tampere
Tampere University Hospital, Tampere
Turku University Hospital, Turku
Vaasa Central Hospital, Vaasa
Sørlandet sykehus HF, Arendal
Oslo University Hospital, Ullevål Hospital, Oslo
Martina Hansens Hospital, Sandvika
St. Olafs Hospital HF, Trondheim
Skånevård Sund, Region Skåne, Helsingborg
Kalmar County Hospital, Kalmar
Linköping University Hospital, Linköping
Varberg Hospital, Varberg
Turku University Hospital
OTHER_GOV