Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy Eligible For Reverse Shoulder Arthroplasty: the ReAct Multicenter, Randomized Controlled Trial

Conditions
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Rotator Cuff Arthropathy

Intervention / Treatment
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* Procedure: TSA-group
* Other: Exercise-group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 60-85 years Eligible for RSA Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSA-group<br>Surgery | Procedure: TSA-group<br>* Reverse total shoulder arthroplasty followed by standard rehabilitation.<br>|
| Experimental: Exercise-group<br>Exercise | Other: Exercise-group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 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 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 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 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physiotherapist-supervised Exercise, Physical Therapy, Physical Rehabilitation, Reverse Shoulder Arthroplasty, Randomized Controlled Trial, Cuff Tear Arthropathy