Prognosis and Predictors of ACL Reconstruction - A Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,294
- 试验地点
- 8
- 主要终点
- patient-reported outcome measures
研究概览
简要总结
The purpose of this study is to determine the effect of modifiable risk factors on knee function, osteoarthritis, and re-rupture of the anterior cruciate ligament (ACL) following ACL reconstruction.
详细描述
Disruption of the anterior cruciate ligament (ACL) is among the most frequent musculoskeletal injuries affecting physically active men and women. An estimated 200,000 ACL reconstructions (ACLR) are performed annually, and the incidence of this injury is roughly 1 in 3000 per year. ACL injury has both immediate and long-term implications for an injured person's quality of life, their risk for osteoarthritis (OA), and long-term disability. Currently, ACLR is recommended as the standard of care following an ACL tear based on evidence for improved instrumented laxity, the desire to return to sports play, and evidence for a reduction in future knee injuries.
In this research we propose to identify risk factors measurable at the time of injury/surgery in order to estimate the magnitude of the effect of these factors on important quality of life and clinical outcomes (e.g.,OA and incidence of additional surgery) 2 to 10 years after a patient's ACL reconstruction.
AIM 1. To identify risk factors for reduced quality of life 2-20 yrs post-ACLR, from information available at the time of surgery; including the characteristics of the patients (age, gender, body mass index, activity level, clinical knee alignment) and their injuries (concurrent meniscus, articular cartilage, and collateral ligament injuries), and treatment decisions made during the initial surgery (e.g., graft choice, meniscus and articular cartilage treatments).
AIM 2. To identify risk factors for symptoms and signs of osteoarthritis 2-20 years post-ACLR, from information available at the time of surgery; including the characteristics of the patients (as above) and their injuries (as above), and treatment decisions made during ACLR (as above).
AIM 3. To identify risk factors for recurrent ligament disruption and additional arthroscopic knee surgeries of the ACLR knee, from among the characteristics of the patients (as above), their initial injuries (as above), and treatment decisions made during ACLR (as above).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All ACL-deficient candidates scheduled for a unilateral ACL reconstruction at one of the participating MOON sites.
排除标准
- •Persons undergoing a simultaneous bilateral ACL reconstruction
- •Patients less than 10 years old and older than 80 years old
- •Patients unwilling or unable to complete their follow-up questionnaire
结局指标
主要结局
patient-reported outcome measures
时间窗: 2, 6, 10, and 20 years
Sports function (as measured by the KOOS and IKDC). Activity level (as measured by the Marx activity rating scale). General health (as measured by the SF-36).
次要结局
- Signs and symptoms of osteoarthritis(2, 6, 10, and 20 years)
研究者
Kurt P. Spindler
Adjoint Professor
Vanderbilt University Medical Center