NCT00595712已完成3 期
Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Range of motion of the knee
研究概览
简要总结
The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in patients with genovarum deformity using iliac crest allograft compared to the results when using iliac crest autograft.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Varus malalignment of knee with of without osteoarthritis: the angle between the articular surface and anatomical axis of tibia< 82 degrees
- •at least 7.5 mm opening wedge is needed in medial proximal tibia to correct the deformity assessed during pre-op planning
排除标准
- •symptomatic lateral compartment osteoarthritis of knee
- •rheumatoid arthritis or other inflammatory joint diseases
- •less than 100 degrees of knee range of motion
- •grade III laxity in knee collateral ligaments
- •history of surgery or fracture in the limb
- •>15 degrees flexion contracture
- •age <16 or >60 years
- •>20 degrees varus deformity
- •failure to attend follow-up visits
- •sever bone loss in medial tibial plateau or medial femoral condyle
- •>1cm joint subluxation
- •presence of lateral trust during walking
- •presence of patella baja
- •skin derangements on medial proximal tibia
- •any form of nicotine addiction
结局指标
主要结局
Range of motion of the knee
时间窗: before op and at follow ups
knee score (womac)
时间窗: before op and at final follow up
次要结局
未报告次要终点
研究者
研究点 (2)
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