Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy

Last updated: April 14, 2025
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

TSA-group

Exercise-group

Clinical Study ID

NCT04864158
REACT
  • Ages 60-85
  • All Genders

Study 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

Inclusion Criteria:

  • Patients 60-85 years

  • Eligible for RSA

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

Exclusion

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 primaryglenohumeral OA

  • Cancer diagnosis and receiving chemo-, immuno- or radiotherapy

  • Neurological diseases affecting shoulder mobility (e.g. disability after previousstroke, multiple sclerosis, Parkinson's, Alzheimer's disease)

  • Other reasons for exclusion (i.e. mentally unable to participate) or planned absencefor more than 14 days in the first 3 months after baseline test.

  • Unable to communicate in the participating countries respective languages

Study Design

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: TSA-group
Phase:
Study Start date:
May 28, 2021
Estimated Completion Date:
November 30, 2038

Study 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.

Connect with a study center

  • Aarhus University Hospital

    Aarhus N, 8200,
    Denmark

    Active - Recruiting

  • Esbjerg Hospital

    Esbjerg, 6700
    Denmark

    Active - Recruiting

  • Aalborg University Hospital

    Farsø, 9640
    Denmark

    Active - Recruiting

  • Silkeborg Regional Hospital

    Silkeborg, 8600
    Denmark

    Active - Recruiting

  • Viborg Regional Hospital

    Viborg, 8800
    Denmark

    Active - Recruiting

  • Tartu University Hospital

    Tartu,
    Estonia

    Active - Recruiting

  • Tampere University Hospital

    Tampere, 33521
    Finland

    Active - Recruiting

  • Oslo University Hospital

    Oslo, 4956
    Norway

    Active - Recruiting

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