Multicenter Randomized Clinical Trial Comparing Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis in Individuals Who Are At High Risk of Graft Failure.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 624
- 试验地点
- 16
- 主要终点
- Graft Failure
研究概览
简要总结
The purpose of this study is to compare outcomes (failure, function, strength, range of motion and quality of life) between patients who receive the usual anterior cruciate ligament (ACL) reconstructive surgery and patients who receive anterior cruciate ligament reconstructive surgery with a lateral extra-articular tenodesis (extra tendon repair on the outside of the knee). Some studies have shown high graft failure rates (ACL re-tear) in young individuals who return to pivoting contact sports following ACL reconstruction. This study is designed to look at whether or not adding this extra tendon repair reduces the risk of graft failure in this population.
详细描述
This study is a pragmatic study for a parallel groups, randomized clinical trial in which 600 patients with anterior cruciate ligament insufficiency who are undergoing surgery, are randomly allocated to either ACL reconstruction alone (control) or ACL reconstruction with lateral extra-articular tenodesis (experimental). Surgeons, data collectors, and the data analyst will be blind to group allocation. The primary outcome is rate of failure. Secondary outcomes include disease specific quality of life, return to function and sport. Patients are followed for two years postoperative.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACL deficient knee
- •skeletally mature to 25 years of age
- •2 or more of:
- •competitive pivoting sport
- •grade 2 pivot shift or greater
- •generalized ligament laxity - Beighton score of 4 or greater
排除标准
- •previous ACL reconstruction on either knee
- •multi-ligament injury (two or more ligaments requiring surgical attention)
- •symptomatic articular cartilage defect requiring treatment other than debridement
- •greater than 3 degrees of asymmetric varus
- •unable to complete outcome questionnaires
结局指标
主要结局
Graft Failure
时间窗: 24 months
* symptomatic instability requiring revision ACL surgery * positive pivot shift or asymmetrical pivot shift greater than other contralateral side We will determine the absolute risk of graft failure in each group, calculate a relative risk (RR) and risk difference (RD) of graft failure with 95% confidence intervals around the estimate and use a Mantel Haentzel Test (random effect of surgeon) to determine the significance of the association between the addition of LET and graft failure rates. We will calculate the number needed to treat (NNT) to describe the number of patients who need to receive LET to prevent one graft failure over the first two postoperative years.
次要结局
- MARX Activity Rating Scale(Baseline, 3, 6, 12, 24 months)
- Radiographic evidence of osteoarthritis(Baseline, 12, 24 months)
- Quality-adjusted life years (QALYs) using the European Quality of Life Scale (Euro-QoL)(Baseline, 3, 6, 12, 24 months)
- Disease-specific quality of life using the ACL Quality of Life Questionnaire (ACL-QOL)(Baseline, 3, 6, 12, 24 months)
- Region-specific quality of life using the Knee Osteoarthritis and outcomes Score (KOOS).(Baseline, 3, 6, 12, 24 months)
- Subjective symptoms, function and activity.(Baseline, 3, 6, 12, 24 months)
- Passive knee extension and active-assisted knee flexion(Baseline, 3, 6, 12, 24 months)