Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
219 participants
OBSERVATIONAL
2020-01-01
2030-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patients
Patients who had ACL reconstruction
No Intervention - Observational study with MRI
90 minute MRI of the knees
Controls
Controls who have no previous knee injury or surgery, no diagnosis of osteoarthritis
No Intervention - Observational study with MRI
90 minute MRI of the knees
Interventions
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No Intervention - Observational study with MRI
90 minute MRI of the knees
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Afraid of enclosed spaces
22 Years
45 Years
ALL
Yes
Sponsors
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Vanderbilt University Medical Center
OTHER
Ohio State University
OTHER
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
The Cleveland Clinic
OTHER
Responsible Party
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Xiaojuan Li
Lead Principal Investigator
Principal Investigators
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Xiaojuan Li, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Other Identifiers
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19-573
Identifier Type: -
Identifier Source: org_study_id
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