NCT04864158 Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
| NCT ID | NCT04864158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Rotator Cuff Arthropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2021-05-28 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2021-05-28 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. However, the effectiveness of RSA 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 RSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with rotator cuff arthropathy eligible for unilateral RSA. The investigators hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (14-point, on a scale from 0-100) improvement compared to the exercise intervention.
Eligibility Criteria
Inclusion Criteria: * Patients 60-85 years * Eligible for RSA * Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33) Exclusion Criteria: * Previous shoulder fracture (fracture of the proximal humerus or glenoid fracture) * Planned other upper extremity surgery within six months * Rheumatoid arthritis or other types of arthritis not diagnosed as primary glenohumeral OA * Cancer diagnosis and receiving chemo-, immuno- or radiotherapy * Neurological diseases affecting shoulder mobility (e.g. disability after previous stroke, multiple sclerosis, Parkinson's, Alzheimer's disease) * Other reasons for exclusion (i.e. mentally unable to participate) or planned absence for more than 14 days in the first 3 months after baseline test. * Unable to communicate in the participating countries respective languages
Contact & Investigator
Josefine B. Larsen, MSc
PRINCIPAL INVESTIGATOR
Aarhus University Hospital and Aarhus University
Frequently Asked Questions
Who can join the NCT04864158 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Rotator Cuff Arthropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04864158 currently recruiting?
Yes, NCT04864158 is actively recruiting participants. Contact the research team at josefinebl@clin.au.dk for enrollment information.
Where is the NCT04864158 trial being conducted?
This trial is being conducted at Aarhus N, Denmark, Esbjerg, Denmark, Farsø, Denmark, Silkeborg, Denmark and 4 additional locations.
Who is sponsoring the NCT04864158 clinical trial?
NCT04864158 is sponsored by University of Aarhus. The principal investigator is Josefine B. Larsen, MSc at Aarhus University Hospital and Aarhus University. The trial plans to enroll 102 participants.