An interventional study of TSA-group and Exercise-group in Rotator Cuff Arthropathy, sponsored by University of Aarhus. Recruiting at 8 sites in 4 countries. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Rotator Cuff Tear Arthropathy; 15 are open to participants now.
This study's planned enrollment of 102 is above the median of 90 across 33 interventional studies indexed under Rotator Cuff Tear Arthropathy.
Browse Rotator Cuff Tear Arthropathy studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Surgery
Procedure: TSA-group
Exercise
Other: Exercise-group
Reverse total shoulder arthroplasty followed by standard rehabilitation.
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.
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).
Time frame: Measured at 12 month follow-up
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).
Time frame: 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
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)
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
Time frame: 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)
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
The patients will be asked which type of analgesics they take (paracetamol, NSAID, morphine/opioids).
Time frame: 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).
Time frame: 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.
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
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.
Time frame: Occurring during the period from inclusion until the 12-month follow-up
Accelerometer-based activity using tri-axial (Axivity, UK) accelerometers
The patients will have an accelerometer sensor mounted with tape to both upper arms for 4 days. The sensors will measure 24/7 activity of the upper arms.
Time frame: Measured at baseline and 12-month follow-up
Accelerometer-based degree of movement using tri-axial (Axivity, UK) accelerometers
The patients will have an accelerometer sensor mounted with tape to both upper arms for 4 days. The sensors will measure 24/7 degree of movement.
Time frame: Measured at baseline and 12-month follow-up
The 100 mm Visual Analogue Scale (exercise-group)
Patient reported pain intensity at rest. With a possible score ranging from 0 to 100, with 100 indicating the worst possible pain.
Time frame: 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.
EuroQol Group 5-dimension 5-level (EQ-5D-5L)
The EuroQol measures the five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each dimension consists of one item, distinguished in five levels. We will used the UK value set in this study, because a Danish value set is not yet available. These values range from -0.285 to 1.0, a value of 1.0 corresponds to full health, 0 corresponds to death and negative values correspond to health status considered to be worse than death.
Time frame: Measured at baseline, 12-week, 12-month, 2- 5- and 10-year follow-up.
Productivity Costs Questionnaire (iPCQ)
The iPCQ is a questionnaire for the measurement of costs in economic evaluations. It consists of 18 questions of which 9 are general questions followed by questions to measure productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work. The minimum value is 0 (no productivity loss) and the maximum value is infinite. Measured for the health economic evaluation in Denmark.
Time frame: Measured at 12-week and 12-month.
Patient Acceptable Symptom State (PASS)
PASS will be assessed with the following question, reported by the patient: "When you think of your shoulder function, will you consider your current condition as satisfying? By shoulder function, you should take into account your activities of daily living, sport and recreational activities, your shoulder pain and other symptoms and your quality-of-life", measured on a dichotomous scale (yes/no).
Time frame: Measured at 12-month, 2-, 5- and 10-year follow-up.
Treatment Failure
Patient-reported treatment failure will be assessed only by patients answering "no" to PASS with the following question: "Would you consider your current state as being so unsatisfactory that you think the treatment has failed?" on a dichotomous scale (yes/no).
Time frame: Measured at 12-month, 2-, 5- and 10-year follow-up.
Number of total shoulder arthroplasty surgeries (exercise-group)
Number of total shoulder arthroplasty surgeries performed in the exercise-group.
Time frame: Measured from baseline to 12-month, 2-, 5- and 10-year follow-up.
Number of supervised exercise sessions from baseline to 3 months (exercise-group)
High compliance will be defined as participation in ≥70 percent of the training sessions; moderate compliance as participation in 50-70 percent of the sessions; and poor compliance as participation in \<50 percent of the sessions.
Time frame: From baseline to 12-week
Number of patients performing unsupervised exercise (exercise-group)
Adherence to two weekly unsupervised exercise sessions will be measured by a patient-reported questionnaire
Time frame: From baseline to 12-week
Number of patients performing unsupervised exercise (exercise-group)
Adherence to optional unsupervised exercise sessions will be measured by a patient-reported questionnaire
Time frame: From 12-week to 12-month
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
Started May 2021 (actual). Primary completion is estimated for Jan 2027, 68 months after the start.
Of 20 interventional studies with no phase under Rotator Cuff Tear Arthropathy, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 72. This study's planned 68 months is close to that.
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