Rotator Cuff ArthropathyREACTNCT04864158
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
A study testing TSA-group and Exercise-group in people with Rotator Cuff Arthropathy, run by University of Aarhus at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Rotator Cuff Arthropathy
- What is being tested?
- TSA-group and Exercise-group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 28 May 2021to Jan 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 60-85 years
- Eligible for RSA
- Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)
Who cannot join
- 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 locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
Denmark5 sites, 5 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N
Josefine Larsen, Msc, josefinebl@clin.au.dk
Inger Mechlenburg, Prof., inger.mechlenburg@clin.au.dk
- Recruiting
Esbjerg Hospital
Esbjerg, 6700
Klaus Hanisch
- Recruiting
Aalborg University Hospital
Farsø, 9640
Steen L Jensen
- Recruiting
Silkeborg Regional Hospital
Silkeborg, 8600
Brian Elmegaard
Stine J Due
- Recruiting
Viborg Regional Hospital
Viborg, 8800
Helle K Østergaard
Srdjan Zivanovic
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu
Kaspar Tootsi
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere, 33521
Antti P. Launonen, PhD, As Prof, antti.launonen@pshp.fi
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 4956
Berte Bøe
About this study
Official title: Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy Eligible For Reverse Shoulder Arthroplasty: the ReAct Multicenter, Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Rotator Cuff Arthropathy
- Being tested
- TSA-group, Exercise-group
- Keywords
- Physiotherapist-supervised Exercise, Physical Therapy, Physical Rehabilitation, Reverse Shoulder Arthroplasty, Randomized Controlled Trial, Cuff Tear Arthropathy
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSA-groupProcedure or surgery
Reverse total shoulder arthroplasty followed by standard rehabilitation.
Exercise-groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RSA-group | Experimental | Surgery Receives: Procedure: TSA-group |
| Exercise-group | Experimental | Exercise Receives: Other: Exercise-group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at 12 month follow-up
Secondary outcomes (8)
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: Measured at baseline, 12-week, 2-, 5- and 10-year follow-up
Disabilities of the Arm, Shoulder and Hand (DASH)
DASH is a self-administered questionnaire that consist of thirty core items and eight items assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, and lower scores correlated to minimal impairments and higher scores indicate more impairment. The cumulative DASH score is scaled from 0-100 with higher scores indicating more disability
Measured: 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)
Patient reported pain intensity at rest, during activity and nightly pain. With a possible score ranging from 0 to 100, with 100 indicating the worst possible pain
Measured: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
The use of analgesics during the last week
The patients will be asked if they take any analgesics (yes/no)
Measured: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
The type of analgesics consumed during the last week
The patients will be asked which type of analgesics they take (paracetamol, NSAID, morphine/opioids).
Measured: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Consumption of analgesics during the last week
The patients will be asked how often they consume the analgesic medication (never, daily, weekly, monthly).
Measured: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Serious Adverse Events
Serious adverse events are defined as embolism (cardiac or brain), death, liver and renal failure.
Measured: The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge.
Adverse events
Defined as any unintended and unfavorable sign, symptom or disease resulting in contact with the healthcare system irrespective of a causal relationship with the intervention and outcome assessments.
Measured: Occurring during the period from inclusion until the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start28 May 2021
- Primary completionJan 2027 (estimated)
- Study completionJan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Tampere University Hospital, Aalborg University Hospital, Regionshospitalet Silkeborg, Oslo University Hospital, The Danish Rheumatism Association, Association of Danish Physiotherapists, Regionshospitalet Viborg, Skive, Esbjerg Hospital - University Hospital of Southern Denmark, Tartu University Hospital
- Responsible party
- Sponsor
- Investigators
- Josefine B. Larsen, MSc, Principal investigator, Aarhus University Hospital and Aarhus UniversityInger Mechlenburg, Prof., Study director, Aarhus University Hospital and Aarhus UniversityTheis M. Thillemann, PhD, As Prof, Study director, Aarhus University Hospital and Aarhus UniversityAntti P. Launonen, PhD, As Prof, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864158
- Sponsor's protocol ID
- REACT
- Acronym
- REACT
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40927835
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy Eligible For Reverse Shoulder Arthroplasty: the ReAct Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04864158
- Acronym / sponsor ID
- REACT / REACT
- Conditions
- Rotator Cuff Arthropathy
- Keywords
- Physiotherapist-supervised Exercise, Physical Therapy, Physical Rehabilitation, Reverse Shoulder Arthroplasty, Randomized Controlled Trial, Cuff Tear Arthropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Tampere University Hospital, Aalborg University Hospital, Regionshospitalet Silkeborg, Oslo University Hospital, The Danish Rheumatism Association, Association of Danish Physiotherapists, Regionshospitalet Viborg, Skive, Esbjerg Hospital - University Hospital of Southern Denmark, Tartu University Hospital
- Study start
- 28 May 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2037 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSA-group | Experimental | Procedure: TSA-groupSurgery |
| Exercise-group | Experimental | Other: Exercise-groupExercise |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 60-85 years
- Eligible for RSA
- Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSA-groupReverse total shoulder arthroplasty followed by standard rehabilitation. | Procedure or surgery | RSA-group |
| Exercise-groupThe 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. | Other | Exercise-group |
Primary outcome
the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
Time frame: Measured at 12 month follow-up
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).
8 secondary outcomes
the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
Time frame: Measured at baseline, 12-week, 2-, 5- and 10-year follow-up
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 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)
Time frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
The use of analgesics during the last week
Time frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
The type of analgesics consumed during the last week
Time frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Consumption of analgesics during the last week
Time frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Serious Adverse Events
Time frame: The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge.
Adverse events
Time frame: Occurring during the period from inclusion until the 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 40927835Larsen 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TSA-group and Exercise-group in people with Rotator Cuff Arthropathy, run by University of Aarhus at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark, Estonia, Finland, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josefine B. Larsen, MSc (4526237771, josefinebl@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Western Ontario Osteoarthritis of the Shoulder index (WOOS) (time frame: Measured at 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04864158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.