Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
- Conditions
- Rotator Cuff Arthropathy
- Interventions
- Other: Exercise-groupProcedure: TSA-group
- Registration Number
- NCT04864158
- Lead Sponsor
- University of Aarhus
- Brief 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. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
- Patients 60-85 years
- Eligible for RSA
- Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise-group Exercise-group Exercise RSA-group TSA-group Surgery
- Primary Outcome Measures
Name Time Method the Western Ontario Osteoarthritis of the Shoulder index (WOOS) 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).
- Secondary Outcome Measures
Name Time Method The change in pain measured on a 100 mm Visual Analogue Scale (VAS) Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up 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
The use of analgesics during the last week Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up The patients will be asked if they take any analgesics (yes/no)
Consumption of analgesics during the last week Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up The patients will be asked how often they consume the analgesic medication (never, daily, weekly, monthly).
Adverse events Occurring during the period from inclusion until the 12-month follow-up 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.
the Western Ontario Osteoarthritis of the Shoulder index (WOOS) Measured at baseline, 12-week, 2-, 5- and 10-year 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).
The type of analgesics consumed during the last week Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up The patients will be asked which type of analgesics they take (paracetamol, NSAID, morphine/opioids).
Disabilities of the Arm, Shoulder and Hand (DASH) Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up 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
Serious Adverse Events The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge. Serious adverse events are defined as embolism (cardiac or brain), death, liver and renal failure.
Trial Locations
- Locations (8)
Aalborg University Hospital
🇩🇰Farsø, Denmark
Silkeborg Regional Hospital
🇩🇰Silkeborg, Denmark
Viborg Regional Hospital
🇩🇰Viborg, Denmark
Tampere University Hospital
🇫🇮Tampere, Finland
Oslo University Hospital
🇳🇴Oslo, Norway
Tartu University Hospital
🇪🇪Tartu, Estonia
Aarhus University Hospital
🇩🇰Aarhus N, 8200, Denmark
Esbjerg Hospital
🇩🇰Esbjerg, Denmark