Prosthesis versus exercise for rotator cuff tear arthropathy - protocol of a randomised controlled trial.
Josefine Beck Larsen, Theis Muncholm Thillemann, Antti P Launonen...
https://pubmed.ncbi.nlm.nih.gov/40927835/Actively Recruiting
Led by University of Aarhus · Updated on 2026-07-02
102
Participants Needed
8
Research Sites
521 weeks
Total Duration
Researchers are evaluating treatments for rotator cuff arthropathy, a condition involving large rotator cuff tears combined with shoulder joint degeneration causing pain and loss of mobility. This trial compares reverse shoulder arthroplasty RSA, a surgical procedure currently used for this condition, with a non-surgical 12-week exercise program. The goal is to determine whether surgery followed by standard rehabilitation results in better shoulder function and pain relief than exercise alone in patients eligible for unilateral RSA. Participants are randomly assigned to one of two groups. The surgical group will receive reverse total shoulder arthroplasty followed by usual post-surgical rehabilitation. The non-surgical group will participate in a 12-week exercise program including one weekly supervised session with a physiotherapist and two additional home-based exercise sessions per week. Exercises focus on shoulder motion and muscle strength, guided by a standardized protocol. Educational materials about the condition and exercise-related pain are also provided to the exercise group. Participants will be assessed at the start of the study, after 3 months, 12 months, and then at 2, 5, and 10 years following treatment. Evaluations include patient-reported outcomes such as the Western Ontario Osteoarthritis of the Shoulder index and the Disabilities of the Arm, Shoulder and Hand questionnaire. Pain levels, analgesic use, and adverse events will be monitored. The surgical group will be closely observed for serious adverse events during the first 4 weeks after hospital discharge. The total duration of involvement can extend up to 10 years depending on follow-up schedules.
CONDITIONS
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
J
Josefine B. Larsen, MSc
I
Inger Mechlenburg, Prof.
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University of Aarhus
Lead Sponsor
Aarhus University Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive either reverse shoulder arthroplasty followed by standard rehabilitation or participate in a 12-week exercise program with weekly physiotherapist sessions and home exercises.
Weekly physiotherapist-supervised exercise sessions for the exercise group
Duration - Up to 10 years
Participants are evaluated at 3 months, 12 months, and then at 2, 5, and 10 years after treatment to assess shoulder function, pain, and adverse events.
Scheduled follow-up visits at multiple time points
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Josefine Beck Larsen, Theis Muncholm Thillemann, Antti P Launonen...
https://pubmed.ncbi.nlm.nih.gov/40927835/University of Aarhus
Lead Sponsor
Aarhus University Hospital
Collaborating Sponsor