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/40927835Actively Recruiting
Led by University of Aarhus · Updated on 2025-04-17
102
Participants Needed
8
Research Sites
521 weeks
Total Duration
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
Rotator cuff arthropathy is a condition involving large rotator cuff tears combined with shoulder joint damage that causes pain, swelling, and limited movement. Researchers are comparing the effectiveness of reverse shoulder arthroplasty (RSA), a surgical treatment, to a non-surgical 12-week exercise program in patients with this condition who are eligible for unilateral RSA. The goal is to determine if surgery followed by standard rehabilitation leads to better improvements in shoulder function and pain than exercise alone. Participants will be randomly assigned to one of two groups: one will receive reverse total shoulder arthroplasty followed by standard post-surgery rehabilitation, while the other will complete a 12-week exercise program. This exercise program includes one supervised session weekly with a physiotherapist plus two home exercise sessions each week, focusing on shoulder movement and strength. Educational materials about shoulder osteoarthritis and exercise-related pain will also be provided to those in the exercise group. During the study, patients will undergo assessments at the start, 3 months, 12 months, and then at 2, 5, and 10 years after treatment begins. These evaluations include patient-reported outcomes using the Western Ontario Osteoarthritis of the Shoulder index, disability scores, pain scales, and medication use. Safety will be monitored through the recording of adverse events, particularly during the first month after surgery. The total participation period may last up to 10 years, with careful follow-up to measure long-term results.
CONDITIONS
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 12 weeks
Participants are randomized to receive either reverse total shoulder arthroplasty followed by standard rehabilitation, or a 12-week exercise program with one weekly physiotherapist-supervised session and home-based exercises.
Weekly physiotherapist-supervised exercise sessions for exercise group; surgery and usual care for surgery group
Duration - Up to 10 years
Participants are monitored with outcome assessments at 3 months, 12 months, and long-term follow-up up to 10 years after treatment start.
Visits at baseline, 3 months, 12 months, 2 years, 5 years, and 10 years
Total: 8 locations
1
Aarhus University Hospital
Aarhus N, Denmark
Actively Recruiting
2
Esbjerg Hospital
Esbjerg, Denmark, 6700
Actively Recruiting
3
Aalborg University Hospital
Farsø, Denmark, 9640
Actively Recruiting
4
Silkeborg Regional Hospital
Silkeborg, Denmark, 8600
Actively Recruiting
5
Viborg Regional Hospital
Viborg, Denmark, 8800
Actively Recruiting
6
Tartu University Hospital
Tartu, Estonia
Actively Recruiting
7
Tampere University Hospital
Tampere, Finland, 33521
Actively Recruiting
8
Oslo University Hospital
Oslo, Norway, 4956
Actively Recruiting
J
Josefine B. Larsen, MSc
I
Inger Mechlenburg, Prof.
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