Actively Recruiting

Phase Not Applicable
Age: 60Years - 85Years
All Genders
ID04864158

Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy Eligible For Reverse Shoulder Arthroplasty: the ReAct Multicenter, Randomized Controlled Trial

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

102

Participants Needed

8

Research Sites

521 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

Rotator cuff arthropathy is a condition involving large rotator cuff tears combined with shoulder joint damage that causes pain, swelling, and limited movement. Researchers are comparing the effectiveness of reverse shoulder arthroplasty (RSA), a surgical treatment, to a non-surgical 12-week exercise program in patients with this condition who are eligible for unilateral RSA. The goal is to determine if surgery followed by standard rehabilitation leads to better improvements in shoulder function and pain than exercise alone. Participants will be randomly assigned to one of two groups: one will receive reverse total shoulder arthroplasty followed by standard post-surgery rehabilitation, while the other will complete a 12-week exercise program. This exercise program includes one supervised session weekly with a physiotherapist plus two home exercise sessions each week, focusing on shoulder movement and strength. Educational materials about shoulder osteoarthritis and exercise-related pain will also be provided to those in the exercise group. During the study, patients will undergo assessments at the start, 3 months, 12 months, and then at 2, 5, and 10 years after treatment begins. These evaluations include patient-reported outcomes using the Western Ontario Osteoarthritis of the Shoulder index, disability scores, pain scales, and medication use. Safety will be monitored through the recording of adverse events, particularly during the first month after surgery. The total participation period may last up to 10 years, with careful follow-up to measure long-term results.

CONDITIONS

Brief 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 aged 60 to 85 years
  • Eligible for reverse shoulder arthroplasty (RSA)
  • Diagnosed with rotator cuff arthropathy classified as Hamada grade 3, 4, or 5
Not Eligible

You will not qualify if you...

  • Previous shoulder fracture (proximal humerus or glenoid fracture)
  • Planned upper extremity surgery within six months
  • Rheumatoid arthritis or other arthritis types except primary glenohumeral osteoarthritis
  • Current cancer diagnosis receiving chemotherapy, immunotherapy, or radiotherapy
  • Neurological diseases affecting shoulder movement (e.g., stroke disability, multiple sclerosis, Parkinson's, Alzheimer's disease)
  • Mentally unable to participate or planned absence exceeding 14 days within first 3 months after baseline
  • Unable to communicate in the languages of participating countries

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - 12 weeks

Participants are randomized to receive either reverse total shoulder arthroplasty followed by standard rehabilitation, or a 12-week exercise program with one weekly physiotherapist-supervised session and home-based exercises.

Weekly physiotherapist-supervised exercise sessions for exercise group; surgery and usual care for surgery group

Follow-up

Duration - Up to 10 years

Participants are monitored with outcome assessments at 3 months, 12 months, and long-term follow-up up to 10 years after treatment start.

Visits at baseline, 3 months, 12 months, 2 years, 5 years, and 10 years

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

I

Inger Mechlenburg, Prof.

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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Published Research Related To This Trial

Prosthesis versus exercise for rotator cuff tear arthropathy - protocol of a randomised controlled trial.

Josefine Beck Larsen, Theis Muncholm Thillemann, Antti P Launonen...

https://pubmed.ncbi.nlm.nih.gov/40927835