Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis
- Conditions
- Glenohumeral Osteoarthritis
- Interventions
- Procedure: TSA-groupOther: Exercise-group
- Registration Number
- NCT04845074
- Lead Sponsor
- University of Aarhus
- Brief 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. 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 102
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TSA-group TSA-group Surgery Exercise-group Exercise-group Exercise
- 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 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.
The 100 mm Visual Analogue Scale. 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.
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).
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.
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 use of analgesics during the last week Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up They will be asked if they take any analgesics, which type they take (paracetamol, NSAID, morphine/opioids) and how often they consume the medication.
Trial Locations
- Locations (7)
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Silkeborg Regional Hospital
🇩🇰Silkeborg, Denmark
Esbjerg Hospital
🇩🇰Esbjerg, Denmark
Aalborg University Hospital
🇩🇰Farsø, Denmark
Viborg Regional Hospital
🇩🇰Viborg, Denmark
Tampere University Hospital
🇫🇮Tampere, Finland
Oslo University Hospital
🇳🇴Oslo, Norway