Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorUniversity of Aarhus

About this trial

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

Qualifiers

Patients 60-85 years

Eligible for RSA

Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • TSA-group
  • Exercise-group

Treatment groups

102 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator

Tampere University Hospital

Collaborator

Aalborg University Hospital

Collaborator

Regionshospitalet Silkeborg

Collaborator

Oslo University Hospital

Collaborator

The Danish Rheumatism Association

Collaborator

Association of Danish Physiotherapists

Collaborator

Regionshospitalet Viborg, Skive

Collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

Collaborator

Tartu University Hospital

Collaborator