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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Tampere University Hospital | OTHER |
| Regionshospitalet Viborg, Skive | OTHER |
| Aalborg University Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TSA-group | Experimental | Surgery |
|
| Exercise-group | Experimental | Exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSA-group | Procedure | Anatomical total shoulder arthroplasty followed by standard rehabilitation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 baseline, 12-week, 2-, 5- and 10-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 and degree of movement. | Measured at baseline and 12-month follow-up |
| The 100 mm Visual Analogue Scale. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josefine B. Larsen, MSc | Aarhus University Hospital and Aarhus University | Principal Investigator |
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark | |||
| Esbjerg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35138410 | Derived | 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. |
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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.
Data will be available after publication of the trial.
Data access will be reviewed by the author group. Requestors will be required to sign a Data Access Agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2024 | Jul 11, 2024 | SAP_000.pdf |
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| OTHER |
| Regionshospitalet Silkeborg | OTHER |
| Oslo University Hospital | OTHER |
| The Danish Rheumatism Association | OTHER |
| Association of Danish Physiotherapists | OTHER |
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
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| Exercise-group | Other | 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. |
|
| 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 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 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 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. | 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. | Occurring during the period from inclusion until the 12-month follow-up |
Patient reported pain intensity at rest |
| Measured immediately before and after each exercise session |
| 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. | 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. Measured for the health economic evaluation in Denmark. | Measured at 12-week, 12-month follow-up. |
| Patient Acceptable Symptom State (PASS) | PASS will be assessed with the following question: "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 on a dichotomous scale (yes/no). | 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). | 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. | 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% of the training sessions; moderate compliance as participation in 50-70% of the sessions; and poor compliance as participation in <50% of the sessions. | From baseline to 12 weeks |
| Number of patients performing unsupervised exercise (exercise-group) | Adherence to two weekly unsupervised exercise sessions will be measured by a patient-reported questionnaire | From baseline to 12 weeks |
| Number of patients performing unsupervised exercise (exercise-group) | Adherence to optional unsupervised exercise sessions will be measured by a patient-reported questionnaire | From 12 weeks to 12 months |
| Esbjerg |
| 6700 |
| Denmark |
| Aalborg University Hospital | Farsø | 9640 | Denmark |
| Silkeborg Regional Hospital | Silkeborg | 8600 | Denmark |
| Viborg Regional Hospital | Viborg | 8800 | Denmark |
| Tampere University Hospital | Tampere | 33521 | Finland |
| Oslo University Hospital | Oslo | 4956 | Norway |