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Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis
Sponsor: University of Aarhus
Summary
Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral osteoarthritis. The primary aim of this trial is to examine if TSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with primary glenohumeral OA eligible for unilateral TSA. We hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (18-point, on a scale from 0-100) improvement compared to the exercise intervention.
Official title: Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis Eligible For Shoulder Arthroplasty: the ProAct Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
55 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2021-06-02
Completion Date
2035-11
Last Updated
2025-04-15
Healthy Volunteers
No
Conditions
Interventions
TSA-group
Anatomical total shoulder arthroplasty followed by standard rehabilitation.
Exercise-group
The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.
Locations (7)
Aarhus University Hospital
Aarhus, Denmark
Esbjerg Hospital
Esbjerg, Denmark
Aalborg University Hospital
Farsø, Denmark
Silkeborg Regional Hospital
Silkeborg, Denmark
Viborg Regional Hospital
Viborg, Denmark
Tampere University Hospital
Tampere, Finland
Oslo University Hospital
Oslo, Norway