Time to Total Hip Replacement in Patients With Hip Osteoarthritis Going Through Both Supervised Exercise and Patient Education Compared to Those Going Through Patient Education Only. A 3.5-6 Year Follow-up of a Randomized, Controlled, Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Time to Total Hip Replacement surgery (THR)
研究概览
简要总结
The purpose of this study is to evaluate the time to total hip replacement in patients with hip osteoarthritis going through both a supervised exercise program and patient education compared to patients going through patient education only.
The null hypothesis is: There are no differences in time to total hip replacement between patients with hip osteoarthritis who went through a 12 week supervised exercise program and patient education compared to patients who went through patient education only.
Material and methods:
109 patients with both symptomatically and radiographically verified hip osteoarthritis were included in this randomized controlled trial between april 2005 and october 2007. They were randomized to either a 12 week supervised exercise program and patient education (n=55) or patient education only (n=54).
Information on if and when total hip replacement is performed will be collected between April 1st and May 1st. Time since inclusion to follow-up will range from 3.5 to 6 years. Data will be collected directly from the study participants by telephone.
The main outcome is time to total hip replacement.
Status:
This study is a prolongation of an on-going RCT (3a-2005-NAR) using clinical outcomes to evaluate the effect of supervised exercise and patient education.
The study will be carried out: NAR-Department of Orthopedics, Ullevaal University Hospital.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 40 and 80 years old with uni- or bilateral hip disability.
- •Hip pain for more then 3 months.
- •Harris Hip Score between 60 and
- •Harris Hip score (0-100 points) is widely used as an assessment of hip function in patients with hip OA. Harris Hip Score of 60 or below are used regularly at our institution as one of the criteria for total hip replacement surgery.
- •Radiographic verified hip OA (Danielsson's criteria for radiographic OA: Danielsson's criteria for minimal joint space: < 4 mm < 70 years, < 3 mm ≥ 70 years, or 1 mm difference between hips).
排除标准
- •Patients who have a history of resent trauma or functional impairment to the lower limbs or diseases which might interfere with participation (rheumatoid arthritis, cancer, osteoporosis, severe back pain, knee OA).
- •Patients with co-morbidities not tolerating physical activities
结局指标
主要结局
Time to Total Hip Replacement surgery (THR)
时间窗: 3.5 to 6 years after inclusion
All included patients will be examined regarding if they have gone through THR surgery since their inclusion in the present study. For those who report to have gone through THR surgery, date for when surgery were performed will be collected.
次要结局
未报告次要终点