Outcomes of Anterior Cruciate Ligament Reconstruction With and Without High Tibial Osteotomy in Knees With Varus Malalignment. Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Lysholm knee score
研究概览
简要总结
The purpose of this study is to compare the results of single-stage anterior cruciate ligament reconstruction combined with high tibial osteotomy and anterior cruciate ligament reconstruction alone in knees with varus malalignment and anterior cruciate ligament deficiency. Evaluation will be clinically, radiologically and time needed to return to pre injury activity level. Our Hypothesis: Simultaneous anterior cruciate ligament reconstruction and high tibial osteotomy provides good functional scores, low rate of graft failure and early return to pre injury activity level with minimal added morbidity.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and
- •Knee varus malalignment 7-10°.
- •ACL injury with clinical anterior instability confirmed by MRI.
排除标准
- •Osteoarthritis (Kellgren-Lawrence grade IV).
- •Inflammatory joint disease.
- •Knee flexion < 120°
- •Knee fixed flexion deformity > 10°.
- •Any ligamentous or meniscal knee injury other than ACL injury.
结局指标
主要结局
Lysholm knee score
时间窗: 6 month post operative
knee score from 0 to 100 where a higher score means better outcome.
Return to pre injury level
时间窗: through study completion, an average of 7 months
time needed by the patient in months post operative to return to pre injury activity level
Tegner activity level
时间窗: 6 months post operative
activity level from 0 to 11 where 11 means highest level
次要结局
- knee range of motion(pre operative, 1 month, 3months, and 6 months post operative)
- knee stability(pre operative, 1 month, 3months, and 6 months post operative)
研究者
Mostafa Hassanein, Msc
principal investigator
Ain Shams University