NCT02111759Unknown不适用
The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction - A Multicentre, Patient and Assessor Blinded, Stratified, Two-arm Parallel Group Superiority Trial
University of Toronto Orthopaedic Sports Medicine2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2014年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
The purpose of this study is to conduct a randomized controlled trial to determine if the knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft fixation has an effect on postoperative outcomes. The specific research questions are: what is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI
- •No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system
- •Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion
- •surgical management with a transtibial or anteromedial portal single-bundle ACLR with bone patella tendon bone (BPTB) autograft by a fellowship-trained sports medicine surgeon.
排除标准
- •Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters
- •Associated grade III injury to the MCL (medial opening >10mm at 30 degrees of knee flexion or any medial opening in extension)
- •Presence of a PCL or posterolateral corner injury
- •Lack of informed consent.
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 24 months postoperatively
次要结局
- Side to side differences in anterior-posterior (AP) stability(3, 6, 12, and 24 months)
- KOOS scores(3, 6, and 12 months)
- Marx Activity Score (MAS)(3, 6, 12, 24 months)
- the degree of extension loss in the affected knee (vs. contralateral knee)(3, 6, 12, and 24 months)
研究者
Jaskarndip Chahal
Principal Investigator
University of Toronto Orthopaedic Sports Medicine
研究点 (2)
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