Comparing shoulder surgery to exercise for rotator cuff problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of reverse shoulder arthroplasty (RSA) compared to a 12-week physiotherapist-supervised exercise program in patients with rotator cuff arthropathy. Participants eligible for RSA will be randomly assigned to either receive the surgical intervention followed by standard rehabilitation or to engage solely in the exercise program. The primary outcome will be assessed using the Western Ontario Osteoarthritis of the Shoulder index score at 12 months, with follow-ups at various intervals. The study aims to determine if surgical treatment leads to significantly better outcomes than non-surgical exercise therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Aarhus University Hospital
  Aarhus N, Denmark Recruiting
• Esbjerg Hospital
  Esbjerg, Denmark Recruiting
• Aalborg University Hospital
  Farsø, Denmark Recruiting
• Silkeborg Regional Hospital
  Silkeborg, Denmark Recruiting
• Viborg Regional Hospital
  Viborg, Denmark Recruiting
• Tartu University Hospital
  Tartu, Estonia Recruiting

Study contacts

• Principal investigator: Josefine B. Larsen, MSc — Aarhus University Hospital and Aarhus University
• Study coordinator: Josefine B. Larsen, MSc
• Email: josefinebl@clin.au.dk
• Phone: 4526237771

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.