Primary ACL Reconstruction in Patient Over 40 Years: Allograft Versus Autograft, a Prospective Matched Paired Comparison
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare the difference in graft failure between allograft vs autograft ACL reconstruction
研究概览
简要总结
The aim of this study is to investigate the differences in graft failure between patients that underwent ACL reconstruction using allograft tendons and patients that underwent ACL reconstruction using autograft tendons in patients older than 40 y.o. and after at least 2 years of follow-up. The hypothesis of the study is that there will be a difference in graft failure and patient reported functional outcomes between allograft and autograft ACL reconstruction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male and female patients of fertile age can be recruited
- •Patients aged 40 years old and above, and 2 years minimum of follow-up
- •Patients that underwent primary ACL reconstruction with allograft an autograft tendons
排除标准
- •Multiligamentous lesion
- •Meniscal tear leading to subtotal or total meniscectomy or meniscal graft
- •Indication for major cartilage restoration or resurfacing
- •Ipsilateral knee fractures
- •History of ligament injury
- •Concomitant extracapsular procedures
- •Ipsilateral or contralateral knee surgeries
结局指标
主要结局
To compare the difference in graft failure between allograft vs autograft ACL reconstruction
时间窗: from 2 years after surgical procedure
Clinical evaluation measuring the percentage in graft failure between allograft and autograft ACL reconstruction
次要结局
- To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction(from 2 years after surgical procedure)
研究者
Professor Giacomo Placella
Professor
IRCCS Ospedale San Raffaele