Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
REACT
1 other identifier
interventional
102
4 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2021
CompletedFirst Posted
Study publicly available on registry
April 28, 2021
CompletedStudy Start
First participant enrolled
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2038
April 17, 2025
April 1, 2025
7.4 years
April 13, 2021
April 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
WOOS consist of 19 items to be answered using a visual analog scale (VAS). Each item has a possible score ranging from 0 to 100, leading to a total WOOS score ranging from 0 to 1900, with 0 being the best. For simplicity reasons, raw scores can be converted to a percentage of the maximum score (0-100, 100 best).
Measured at 12 month follow-up
Secondary Outcomes (8)
the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
Measured at baseline, 12-week, 2-, 5- and 10-year follow-up
Disabilities of the Arm, Shoulder and Hand (DASH)
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
The change in pain measured on a 100 mm Visual Analogue Scale (VAS)
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
The use of analgesics during the last week
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
The type of analgesics consumed during the last week
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
- +3 more secondary outcomes
Other Outcomes (11)
Accelerometer-based activity using tri-axial (Axivity, UK) accelerometers
Measured at baseline and 12-month follow-up
Accelerometer-based degree of movement using tri-axial (Axivity, UK) accelerometers
Measured at baseline and 12-month follow-up
The 100 mm Visual Analogue Scale (exercise-group)
Measured immediately before and immideately after each exercise session. From the date of the start of the exercise intervention until the end of the exercise intervention, assessed up to 12 months.
- +8 more other outcomes
Study Arms (2)
RSA-group
EXPERIMENTALSurgery
Exercise-group
EXPERIMENTALExercise
Interventions
The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.
Eligibility Criteria
You may qualify if:
- Patients 60-85 years
- Eligible for RSA
- Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)
You may not qualify if:
- 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)
- Unable to communicate in the participating countries respective languages
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Tampere University Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- Regionshospitalet Silkeborgcollaborator
- Oslo University Hospitalcollaborator
- The Danish Rheumatism Associationcollaborator
- Association of Danish Physiotherapistscollaborator
- Regionshospitalet Viborg, Skivecollaborator
- Esbjerg Hospital - University Hospital of Southern Denmarkcollaborator
- Tartu University Hospitalcollaborator
Study Sites (8)
Aarhus University Hospital
Aarhus N, Denmark
Esbjerg Hospital
Esbjerg, 6700, Denmark
Aalborg University Hospital
Farsø, 9640, Denmark
Silkeborg Regional Hospital
Silkeborg, 8600, Denmark
Viborg Regional Hospital
Viborg, 8800, Denmark
Tartu University Hospital
Tartu, Estonia
Tampere University Hospital
Tampere, 33521, Finland
Oslo University Hospital
Oslo, 4956, Norway
Related Publications (1)
Larsen JB, Thillemann TM, Launonen AP, Ostergaard HK, Falstie-Jensen T, Reito A, Jensen SL, Mechlenburg I. Prosthesis versus exercise for rotator cuff tear arthropathy - protocol of a randomised controlled trial. Dan Med J. 2025 Aug 22;72(9):A09240645. doi: 10.61409/A09240645.
PMID: 40927835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josefine B. Larsen, MSc
Aarhus University Hospital and Aarhus University
- STUDY DIRECTOR
Inger Mechlenburg, Prof.
Aarhus University Hospital and Aarhus University
- STUDY DIRECTOR
Theis M. Thillemann, PhD, As Prof
Aarhus University Hospital and Aarhus University
- STUDY DIRECTOR
Antti P. Launonen, PhD, As Prof
Tampere University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2021
First Posted
April 28, 2021
Study Start
May 28, 2021
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2038
Last Updated
April 17, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be available after publication of the trial
- Access Criteria
- Data access will be reviewed by the author group. Requestors will be required to sign a Data Access Agreement.
Pseudo anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.