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MOON Onsite MRI 10 Years After ACL Reconstruction

Imaging Post-traumatic Osteoarthritis 10-years After ACL Reconstruction

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04660955
Acronym
MRI
Enrollment
219
Registered
2020-12-09
Start date
2020-01-01
Completion date
2030-01-01
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief 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.

Interventions

OTHERNo Intervention - Observational study with MRI

90 minute MRI of the knees

Sponsors

The Cleveland Clinic
Lead SponsorOTHER
Vanderbilt University Medical Center
CollaboratorOTHER
Ohio State University
CollaboratorOTHER
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
22 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* History of surgery on contralateral knee * Afraid of enclosed spaces

Design outcomes

Primary

MeasureTime frameDescription
Cartilage health statusAt 10-years after ACL reconstructionQuantitative 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.

Secondary

MeasureTime frameDescription
Patient reported outcomesAt 10-years after ACL reconstructionPain score (0-100) evaluated using Knee injury and Osteoarthritis Outcome Score (KOOS)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORXiaojuan Li, PhD

The Cleveland Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026