Actively Recruiting

Phase Not Applicable
Age: 60Years - 85Years
All Genders
NCT04864158

Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy

Led by University of Aarhus · Updated on 2025-04-17

102

Participants Needed

8

Research Sites

909 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy

Who Can Participate

Age: 60Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 60-85 years
  • Eligible for reverse shoulder arthroplasty
  • Rotator cuff arthropathy classified as Hamada grade 3, 4, or 5
Not Eligible

You will not qualify if you...

  • Previous proximal humerus or glenoid fracture
  • Planned upper extremity surgery within six months
  • Rheumatoid arthritis or other arthritis types not primary glenohumeral osteoarthritis
  • Current cancer treatment with chemotherapy, immunotherapy, or radiotherapy
  • Neurological diseases affecting shoulder movement (e.g., stroke disability, multiple sclerosis, Parkinson's, Alzheimer's)
  • Mental inability to participate or planned absence over 14 days in first 3 months
  • Unable to communicate in the study country's language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Aarhus University Hospital

Aarhus N, Denmark

Actively Recruiting

2

Esbjerg Hospital

Esbjerg, Denmark, 6700

Actively Recruiting

3

Aalborg University Hospital

Farsø, Denmark, 9640

Actively Recruiting

4

Silkeborg Regional Hospital

Silkeborg, Denmark, 8600

Actively Recruiting

5

Viborg Regional Hospital

Viborg, Denmark, 8800

Actively Recruiting

6

Tartu University Hospital

Tartu, Estonia

Actively Recruiting

7

Tampere University Hospital

Tampere, Finland, 33521

Actively Recruiting

8

Oslo University Hospital

Oslo, Norway, 4956

Actively Recruiting

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Research Team

J

Josefine B. Larsen, MSc

CONTACT

I

Inger Mechlenburg, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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