Imaging Post-traumatic Osteoarthritis 10-years After ACL Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Cartilage health status
研究概览
简要总结
In this study, a total of 219 subjects from the MOON nested cohort will be studied at CCF, Vanderbilt and OSU, Table 1. Among them, some will have added MRI during their 10-year visit for the MOON study. Some subjects who finished their 10-year visit for the MOON Onsite study already will be called back to have MRI. PROMs and other information of these subjects will be collected through the MOON study.
详细描述
In this study, a total of 219 subjects from the MOON nested cohort will be studied at CCF, Vanderbilt and OSU, Table 1. Among them, some will have added MRI during their 10-year visit for the MOON study. Some subjects who finished their 10-year visit for the MOON Onsite study already will be called back to have MRI. PROMs and other information of these subjects will be collected through the MOON study.
In addition, 30 age-, sex- and BMI-matched control subjects (10 from each site) will be recruited and scanned for MRI. PROMs (KOOS, IKDC, Marx, SF-36) will be collected from these controls.
Among the 10 controls recruited locally at CCF, five will also travel to OSU and Vanderbilt to be scanned at the other two sites for cross-validation among the three sites. There will be a separate consent for the 5 controls that will be traveling to each of the 3 sites for the scans. The remaining 25 controls will be tested at only their local site.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in MOON Onsite Study
- •12-33 years old at baseline (22-45 years for this study);
- •ACL tear during a sport; no previous knee injury;
- •No graft rupture during follow-up;
- •No history of surgery on the contralateral knee;
- •No MRI contraindications
排除标准
- •History of surgery on contralateral knee
- •Afraid of enclosed spaces
研究组 & 干预措施
Patients
Patients who had ACL reconstruction
干预措施: No Intervention - Observational study with MRI (Other)
Controls
Controls who have no previous knee injury or surgery, no diagnosis of osteoarthritis
干预措施: No Intervention - Observational study with MRI (Other)
结局指标
主要结局
Cartilage health status
时间窗: At 10-years after ACL reconstruction
Quantitative MRI will be used to quantify cartilage health. Specifically, cartilage MR T1rho and T2 relaxation times will be quantified for cartilage of the knee that had ACL reconstruction, and compared to the contralateral uninjured knee.
次要结局
- Patient reported outcomes(At 10-years after ACL reconstruction)
研究者
Xiaojuan Li
Lead Principal Investigator
The Cleveland Clinic