High Tibial Opening Wedge Osteotomy and Conservative Treatment in Medial Knee Osteoarthritis - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change of KOOS5
研究概览
简要总结
A prospective, randomised controlled trial where clinical and radiological outcome of high tibial opening wedge osteotomy with physiotherapy is compared to physiotherapy alone while treating symptomatic medial knee osteoarthrosis.
详细描述
90 Symptomatic patients with mild to moderate medial knee osteoarthrosis are randomized to two groups:
Group 1 (HTO-group) receive an diagnostic arthroscopy with high tibial opening wedge osteotomy (Tomofix-plate). Postoperatively a supervised physiotherapeutic rehabilitation program is started.
Group 2 (FT-group) receive the same supervised physiotherapeutic rehabilitation program without the HTO or arthroscopy.
Primary outcome measure is composite score of Knee injury and Osteoarthritis Outcome Score (KOOS5).
Secondary outcome measures are pain (VAS), KOOS subscales, objective physical performance measurements, progression of osteoarthrosis (X-ray, MRI), change of mechanical axis, complications, treatment costs, rate of reoperation, revision to total knee arthroplasty (TKA), biological markers of arthrosis progression, 15D (quality of life assessment), QALY (Quality-Adjusted Life-Year), Work Productivity and Activity Impairment Questionnaire, Work Productivity and Activity Impairment Questionnaire, sum of governmental benefits received.
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)
盲法说明
The clinical assessors are blinded when applicable.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain: Subjective pain in the knee most of the month for at least one month during past 12 months.
- •Knee range of motion (ROM) at least 5-120 degrees
- •X-ray: medial joint space Altman >
- •Lateral joint space Altman <
- •Mechanical axis > 3 degrees varus alignment.
- •Medial proximal tibial angle (MPTA) < 90 degrees
- •Written consent, accepts both treatment arms.
排除标准
- •Pain is caused by something else than medial knee osteoarthrosis
- •deficient ROM (flexion contracture > 10 degrees, flexion < 110 degrees)
- •significant ligament instability
- •post traumatic OA
- •clinically relevant neurological disease (e.g. Alzheimer´s disease)
- •clinically relevant metabolical disease (e.g. Diabetes)
- •alcohol/drug abuse
- •infectious/inflammatory joint disease
- •previous knee area osteotomy or lower limb arthroplasty
- •smoking (> 0 cigarette per day)
- •obesity (BMI > 33)
- •pregnancy or hope of pregnancy in the following two years
结局指标
主要结局
Change of KOOS5
时间窗: 24, 60, 120 months
The change of Composite score of Knee injury and Osteoarthritis Outcome Score (KOOS) subscales
次要结局
- Change of pain measured in numeric rated scale (NRS)(24, 60, 120 months)
- Change of KOOS subscales(24, 60, 120 months)
- Change in results of stair climb test(24, 60, 120 months)
- Change in mechanical axis of lower limb(12, 24, 60, 120 months)
- Change in results of 40 meter fast paced walk test(24, 60, 120 months)
- Radiological progression of arthrosis(24, 60, 120 months)
- Incidence of complications(Up to 120 months)
- Total costs of treatment(Up to 120 months)
- 15D -quality of life assessement(24, 60, 120 months)
- Change in results of timed up and go test(24, 60, 120 months)
- Amount of national benefits received(Up to 120 months)
- Incidence of reoperation(Up to 120 months)
- Synovial fluid composition(24, 60, 120 months)
- General variables reflecting inflammatory status(24, 60, 120 months)
- Hyaluronic acid (HA) concentration(24, 60, 120 months)
- Fatty acid (FA) profiling(24, 60, 120 months)
- Work Productivity and Activity Impairment Questionnaire (WPAI)(24, 60, 120 months)