NCT00510848已完成不适用
Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament: Randomized Clinical Trial With 2 Year Follow-up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- X-ray, CT-scan, KT1000
研究概览
简要总结
Patients suffering from a rupture of the anterior cruciate ligament (ACL) with instability of the knee joint are treated with an operative ACL-reconstruction: one group of patients with a reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction with an allograft tendon (tibialis posterior). The same surgical technique, the same fixation technique and the same rehabilitation protocol will be used in both groups. Follow-up will be done during 2 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •isolated rupture of the anterior cruciate ligament with instability of the knee joint
- •meniscal tear possible to suture
- •partial meniscectomies
排除标准
- •chronic laxity (more than 9 months)
- •associated collateral laxity (grade III)
- •subtotal or total meniscectomy
- •infection or inflammatory disease of the knee joint
- •large cartilage lesion
结局指标
主要结局
X-ray, CT-scan, KT1000
时间窗: 12 months
次要结局
- X-rays, CT-scan, KT1000(24 months)
研究者
研究点 (2)
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