Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Study With 15-Year Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- osteoarthritis (OA)
研究概览
简要总结
The purpose of this study is to compare double-bundle and single-bundle techniques for ACL reconstruction in a long-term 15-year follow-up. Our hypothesis is that the DB technique is better than the SB technique.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for the study, patients had to meet certain criteria, including primary ACL reconstruction, closed growth plates, and no ligamentous injuries to the contralateral knee.
排除标准
- 未提供
研究组 & 干预措施
Double-bundle
干预措施: ACL reconstruction: Double bundle (Procedure)
Single-bundle
干预措施: ACL reconstruction: Single bundle (Procedure)
结局指标
主要结局
osteoarthritis (OA)
时间窗: 15 years
which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)
graft failures
时间窗: 15 years
which group has more graft failures? The number of graft failures was assessed by revision surgery.
Range on motion (ROM) of the knee
时间窗: 15 years
Which group has more lack of knee extension or lack of knee flexion? Injured knee is always compared to a contralateral "healthy" knee. Measurements were performed with a goniometer. ROM included lack of passive extension (normal \< 3°, nearly normal 3-5°, abnormal 6-10°, and severely abnormal \> 10°) and lack of passive flexion (normal 0-5°, nearly normal 6-15°, abnormal 16-25°, and severely abnormal \> 25°).
One leg hop test
时间窗: 15 years
One leg hop test was performed to assess the functional capacity of the knee. The patient hopped a maximum length three times on each leg separately and the best result was recorded for both legs. The result of the operated leg was then compared with that of the non-operated leg.
Pivot shift
时间窗: 15 years
which group has more positive pivot shift tests? Always compared to a "healthy" knee.
IKDC subjective evaluation. Scale 0-100 (100=best)
时间窗: 15 years
subjective evaluation form
IKDC objective score. Scale 1-4 (1=best)
时间窗: 15 years
Overall evaluation of the knee
KT-1000 arthrometer difference
时间窗: 15 years
Anteroposterior translation. Always compared to a "healthy" knee. mm.
Lysholm score
时间窗: 15 years
subjective evaluation form. Scale 0-100 (100=best)
次要结局
未报告次要终点
研究者
Arttu Seppanen
Principal Investigator
Tampere University Hospital