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Trials / Enrolling By Invitation

Enrolling By InvitationNCT04660955

MOON Onsite MRI 10 Years After ACL Reconstruction

Imaging Post-traumatic Osteoarthritis 10-years After ACL Reconstruction

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
219 (estimated)
Sponsor
The Cleveland Clinic · Academic / Other
Sex
All
Age
22 Years – 45 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERNo Intervention - Observational study with MRI90 minute MRI of the knees

Timeline

Start date
2020-01-01
Primary completion
2026-06-30
Completion
2030-01-01
First posted
2020-12-09
Last updated
2026-03-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04660955. Inclusion in this directory is not an endorsement.