High Tibial Osteotomy for Osteoarthritis of the Knee: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- The achievement of an overcorrection of valgus of 4°.
研究概览
简要总结
A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.
详细描述
A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.
The primary outcome measure was the achievement of an overcorrection of valgus of 4°. Secondary outcome measures were the severity of pain (visual analogue scale), knee function (Hospital for Special Surgery score), and walking distance.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiological OA, medial joint pain and varus malalignment
排除标准
- •Symptomatic OA of the lateral compartment, rheumatoid arthritis, ROM <100, collateral ligament laxity, history of fracture of previous open operation of the lower limb and a flexion contracture > 10 degrees.
结局指标
主要结局
The achievement of an overcorrection of valgus of 4°.
时间窗: one year
The achieved correction will be determined on a whole leg radiograph.
次要结局
- Knee function(one year)
- Walking distance(one year)
- Severity of pain(one year)
研究者
T. Duivenvoorden
M.D.
Erasmus Medical Center