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

University of Aarhus

Status: Enrolling

Conditions: Rotator Cuff Arthropathy

Treatments: Procedure: TSA-group; Other: Exercise-group

Study type: Interventional

Funder types: Other

Identifiers

NCT04864158

REACT

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

RSA-group

Experimental group

Description:

Surgery

Treatment:

Procedure: TSA-group

Exercise-group

Experimental group

Description:

Exercise

Treatment:

Other: Exercise-group