Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis Eligible For Shoulder Arthroplasty: the ProAct Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 12
- 主要终点
- the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TSA-group
Surgery
干预措施: TSA-group (Procedure)
Exercise-group
Exercise
干预措施: Exercise-group (Other)
结局指标
主要结局
the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
时间窗: 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).
次要结局
- Disabilities of the Arm, Shoulder and Hand (DASH)(Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up)
- The 100 mm Visual Analogue Scale.(Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up)
- the Western Ontario Osteoarthritis of the Shoulder index (WOOS)(Measured at baseline, 12-week, 2-, 5- and 10-year follow-up)
- Serious Adverse Events(The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge.)
- Adverse events(Occurring during the period from inclusion until the 12-month follow-up)
- The use of analgesics during the last week(Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up)