Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy (REACT)

  • End date
    Nov 24, 2038
  • participants needed
  • sponsor
    University of Aarhus
Updated on 24 April 2022


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.


Rotator cuff arthropathy describes the clinical scenario of massive rotator cuff ruptures associated with glenohumeral joint degeneration and superior migration of the humeral head. Clinical presentation includes joint effusion, pain, and loss of mobility. Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. Several studies have suggested the need for trials comparing shoulder arthroplasty to non-surgical treatments.

The ProAct trial is a Nordic multicenter randomized controlled trial. Patients with rotator cuff arthropathy, eligible for a RSA will be randomised to either RSA followed by usual care or exercise only. The exercise intervention consists of 12 weeks of exercise with one weekly physiotherapist-supervised exercise session.

The primary outcome will be the total the Western Ontario Osteoarthritis of the Shoulder index score at 12 months follow-up. Outcome assessment will be performed at baseline, and at 3 and 12 months and 2-, 5- and 10 years after start of surgical/non-surgical treatment.

Patients fulfilling the eligibility criteria but declining to participate in the randomised trial will be offered the option of participating in an observational cohort using the same primary end point and patient reported outcomes, but following usual clinical practice.

Condition Rotator Cuff Arthropathy
Treatment TSA-group, Exercise-group
Clinical Study IdentifierNCT04864158
SponsorUniversity of Aarhus
Last Modified on24 April 2022


Yes No Not Sure

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
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