Currently the diagnosis of OA is based on radiographs and clinical findings, which is limited to detecting late-stage disease. There is a pressing, unmet clinical need for robust assessment of early changes in cartilage health. Towards this goal, extensive efforts are ongoing to develop quantitative MRI for cartilage matrix analysis. MR T1ρ and T2 relaxation times have shown to be promising imaging biomarkers for early cartilage degeneration and prediction of disease progression. However, many challenges remain to clinically applying these techniques, including lack of standardized acquisition and quantification methods, and long acquisition times. The study aims to develop novel, fast and reproducible MR T1ρ and T2 relaxation time imaging methods on MR systems from multiple vendors and establish a platform for standardization and cross validation of these measures as a tool for clinical trials using such techniques. Following method validation, patients at risk for osteoarthritis will be tested.
Age 18-50
Sustain an acute full ACL tear in one knee; the contralateral knee uninjured
Undergo ACL reconstructions and standard rehabilitation
Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
Pregnancy.
Contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
Pregnancy.
Subjects between the ages of 18-50 years old. And subjects who sustain an acute full ACL tear in one knee with the contralateral knee uninjured.
Other
Prospective
MRI
Diagnostic testObservational Study of novel MR imaging and image processing techniques that will provide reliable and fully quantitative evaluation of inflammation, chronic structural changes and vascularity in healthy patients and patients with ACL injury.
Knee MRI
Knee MRI will be collected at the 3T scanner (Prisma) at CCF. One time point. The MRI exam time will be two hours per subject including set up. No questionnaires will be required.
Site reproducibility
Knee MRI will be collected at three 3T scanners at CCF (Siemens, GE, Philips), and three scanners at UCSF, University of Kentucky and Albert Einstein College of Medicine, respectively. The three scans at CCF can be on the same day or on different days, but all six scans need to take place within 2 months to minimize potential physiologic variations.To evaluate the reproducibility, subjects will be scanned and then rescanned during one visit on the same day for each of the six scans.
ACL tear and reconstruction
Knee MRI at three 3T scanners at CCF (Siemens, GE, Philips). For patients, the ACL injured and reconstructed knee will be scanned. For controls, to scan which side of the knee (left or right) will be based on subjects' preference. If the subject has no reference, the dominant leg will be scanned. At each time point, the three scans can be on the same day or on different days, but all the three scans need to take place within 2 weeks to minimize potential physiologic variations. For patients with ACL tear and reconstruction, surgical report (including graft type, surgeon recorded lesions) will also be collected.
Site reproducibility with patient outcomes and knee health
Questionnaires of patient reported outcomes (PROMs) including KOOS, IKDC, Marx, SF-36 will be collected at CCF for one time, which will take approximately 30-60 minutes
ACL tear and reconstruction with patient outcomes and knee health
Questionnaires of patient reported outcomes (PROMs) including KOOS, IKDC, Marx, SF-36 will be collected at CCF for baseline and 1-year
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Xiaojuan Li
Lead sponsor
The Cleveland Clinic
Sponsor institution
