Randomized Controlled Trial of Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
The purpose of this study is to compare the effect of total hip arthroplasty and conservative treatment to hip pain, to activities of daily life and to the quality of life in patients with hip osteoarthritis.
详细描述
The purpose of this randomized controlled study is to compare the effect of total hip arthroplasty and conservative treatment (that consists of self-driven exercises that physical therapists teach to the patients) to hip pain, to activities of daily life and to the quality of life in patients with hip osteoarthritis. Also the ill effects and cost effectiveness of total hip arthroplasty and conservative treatment are evaluated. Further more the aim is to investigate if total hip arthroplasty alleviates osteoarthritic pain in 12-month follow-up and if it enhances performance and quality of life.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hip osteoarthritis that is in X-ray pictures ≥2 in Kellgren - Lawrence classification
- •Primary osteoarthritis
- •Patients symptoms of hip osteoarthritis are so severe, that an experienced orthopedist would suggest total hip arthroplasty as a treatment
排除标准
- •Patients symptoms are so severe that total hip arthroplasty should be done within the next three months
- •ASA > 3 (ASA physical status classification system)
- •Normal contraindications to surgery
- •Previous surgery to the same hip that has the osteoarthritis (including total hip arthroplasty, surgery for fracture, osteotomy, arthroscopy)
- •The referring orthopedist has placed the patient in line for hip arthroplasty
- •Secondary osteoarhritis
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: From baseline to one year
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. Higher scores indicate worse pain, stiffness, and functional limitations.
Harris Hip Score (HHS)
时间窗: From baseline to one year
The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty. Four subscales make up HHS. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
次要结局
- Training diary(Baseline to one year)
- Range of motion in hip extension(Baseline to one year)
- Range of motion in hip flexion(Baseline to one year)
- Range of motion in hip inner rotation(Baseline to one year)
- 40m Fast-paced Walk Test(From baseline to one year)
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Pain(From baseline to one year)
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Stiffness(From baseline to one year)
- painDetect(Baseline to one year)
- BMI(Baseline to one year)
- Range of motion in hip outer rotation(Baseline to one year)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Physical Function(From baseline to one year)
- Stair Climb Test(Baseline to one year)
- Grip Strength(Baseline to one year)
- 30s Chair Stand Test(From baseline to one year)
- Short Form 36 Health Survey Questionnaire (SF-36)(Baseline to one year)
- Use of pain medication(Baseline to one year)
- Leg length discrepancy(Baseline to one year)