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Search / Trial NCT04864158

Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy

Launched by UNIVERSITY OF AARHUS · Apr 23, 2021

Trial Information

Current as of April 24, 2025

Recruiting

Keywords

Physiotherapist Supervised Exercise Physical Therapy Physical Rehabilitation Reverse Shoulder Arthroplasty Randomized Controlled Trial Cuff Tear Arthropathy

ClinConnect Summary

This clinical trial is studying two different treatments for patients with rotator cuff arthropathy, a condition that affects the shoulder and can cause pain and limited movement. Specifically, the trial is comparing the effectiveness of reverse shoulder arthroplasty (RSA), a surgical procedure where a damaged shoulder joint is replaced, with a 12-week exercise program aimed at improving shoulder strength and function. Researchers want to find out which option leads to better outcomes, like less pain and improved ability to move the shoulder.

To be eligible for this trial, participants need to be between 60 and 85 years old and must be suitable candidates for the RSA surgery. They should have rotator cuff arthropathy classified as moderate to severe according to specific grading criteria. If you join the trial, you'll either receive the surgery followed by rehabilitation or participate in the exercise program. The study is currently recruiting participants, and it's important to note that those with certain medical conditions or previous shoulder injuries may not be eligible. Overall, the goal is to determine the best treatment approach to help improve the quality of life for those suffering from this shoulder condition.

Gender

ALL

Eligibility criteria

  • 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 Officials

Josefine B. Larsen, MSc

Principal Investigator

Aarhus University Hospital and Aarhus University

Inger Mechlenburg, Prof.

Study Director

Aarhus University Hospital and Aarhus University

Theis M. Thillemann, PhD, As Prof

Study Director

Aarhus University Hospital and Aarhus University

Antti P. Launonen, PhD, As Prof

Study Director

Tampere University Hospital

About University Of Aarhus

The University of Aarhus, a prestigious research institution located in Denmark, is dedicated to advancing medical science through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment that encourages cutting-edge research and the development of novel therapeutic interventions. Committed to ethical standards and patient safety, the University of Aarhus aims to contribute to the global body of medical knowledge while enhancing healthcare outcomes through rigorous scientific inquiry and evidence-based practices.

Locations

Tampere, , Finland

Tartu, , Estonia

Esbjerg, , Denmark

Silkeborg, , Denmark

Oslo, , Norway

Viborg, , Denmark

Farsø, , Denmark

Aarhus N, 8200, , Denmark

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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