Glenohumeral OsteoarthritisPROACTNCT04845074
Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis
A study testing TSA-group and Exercise-group in people with Glenohumeral Osteoarthritis, run by University of Aarhus at 7 sites in 3 countries.
Trial summary
Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared to non-surgical treatment in a randomised controlled trial. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Glenohumeral Osteoarthritis
- 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
- 7 sitesin 3 countries
- Study dates
- 2 Jun 2021to 26 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥55-85 years
- Moderate-severe primary OA of the glenohumeral joint according to Samilson and Prieto, by measuring the lower osteophyte (32)
- Eligible for surgery with standard TSA
Who cannot join
- Surgical need for bonegraft
- 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
7 sites in 3 countries.
7 sites in 3 countries
Denmark5 sites
Aarhus University Hospital
Aarhus, 8200
Esbjerg Hospital
Esbjerg, 6700
Aalborg University Hospital
Farsø, 9640
Silkeborg Regional Hospital
Silkeborg, 8600
Viborg Regional Hospital
Viborg, 8800
About this study
Official title: Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis Eligible For Shoulder Arthroplasty: the ProAct Multicenter, Randomized Controlled Trial
Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. However, the effectiveness of TSA 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 TSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with primary glenohumeral OA eligible for unilateral TSA. We hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (18-point, on a scale from 0-100) improvement compared to the exercise intervention.
Read the detailed description
Glenohumeral osteoarthritis causes pain, stiffness and weakness in the shoulder joint, and furthermore, it affects activities of daily living and quality of life. Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. 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 glenohumeral osteoarthritis, eligible for a TSA will be randomised to either TSA 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
- Glenohumeral Osteoarthritis
- Being tested
- TSA-group, Exercise-group
- Keywords
- Physiotherapist-supervised Exercise, Physical Therapy, Physical Rehabilitation, Anatomical total shoulder arthroplasty, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSA-groupProcedure or surgery
Anatomical 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 |
|---|---|---|
| TSA-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 (6)
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 100 mm Visual Analogue Scale.
Patient reported pain intensity at rest, during activity and nightly pain.
Measured: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
The use of analgesics during the last week
They will be asked if they take any analgesics, which type they take (paracetamol, NSAID, morphine/opioids) and how often they consume the medication.
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 posted14 Apr 2021
- Study start2 Jun 2021
- Primary completion26 May 2026
- Study completion26 May 2026
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 Glenohumeral OsteoarthritisStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Tampere University Hospital, Regionshospitalet Viborg, Skive, Aalborg University Hospital, Regionshospitalet Silkeborg, Oslo University Hospital, The Danish Rheumatism Association, Association of Danish Physiotherapists, Esbjerg Hospital - University Hospital of Southern Denmark
- 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
- NCT04845074
- Sponsor's protocol ID
- PROACT
- Acronym
- PROACT
- Status last verified
- Apr 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
Beck Larsen J, Thillemann TM, Launonen AP, Ostergaard HK, Falstie-Jensen T, Reito A, Lund Jensen S, Mechlenburg I. Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial. Acta Orthop. 2022 Feb 8;93:303-316. doi: 10.2340/17453674.2022.2043.
PubMed 35138410
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 Glenohumeral Osteoarthritis Eligible For Shoulder Arthroplasty: the ProAct Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04845074
- Acronym / sponsor ID
- PROACT / PROACT
- Conditions
- Glenohumeral Osteoarthritis
- Keywords
- Physiotherapist-supervised Exercise, Physical Therapy, Physical Rehabilitation, Anatomical total shoulder arthroplasty, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Tampere University Hospital, Regionshospitalet Viborg, Skive, Aalborg University Hospital, Regionshospitalet Silkeborg, Oslo University Hospital, The Danish Rheumatism Association, Association of Danish Physiotherapists, Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 14 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.
Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. However, the effectiveness of TSA 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 TSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with primary glenohumeral OA eligible for unilateral TSA. We hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (18-point, on a scale from 0-100) improvement compared to the exercise intervention.
Detailed description
Glenohumeral osteoarthritis causes pain, stiffness and weakness in the shoulder joint, and furthermore, it affects activities of daily living and quality of life. Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. 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 glenohumeral osteoarthritis, eligible for a TSA will be randomised to either TSA 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 |
|---|---|---|
| TSA-group | Experimental | Procedure: TSA-groupSurgery |
| Exercise-group | Experimental | Other: Exercise-groupExercise |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥55-85 years
- Moderate-severe primary OA of the glenohumeral joint according to Samilson and Prieto, by measuring the lower osteophyte (32)
- Eligible for surgery with standard TSA
Key exclusion criteria (8 listed)
- Surgical need for bonegraft
- 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
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-groupAnatomical total shoulder arthroplasty followed by standard rehabilitation. | Procedure or surgery | TSA-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).
6 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 100 mm Visual Analogue Scale.
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
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 35138410Beck Larsen J, Thillemann TM, Launonen AP, Ostergaard HK, Falstie-Jensen T, Reito A, Lund Jensen S, Mechlenburg I. Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial. Acta Orthop. 2022 Feb 8;93:303-316. doi: 10.2340/17453674.2022.2043.
- 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. This study is not recruiting at the moment.
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
7 sites in 3 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 Glenohumeral Osteoarthritis, run by University of Aarhus at 7 sites in 3 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 8 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: finished, 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 7 sites in Denmark, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT04845074, 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.