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Enrolling by invitation NCT04660955

MOON Onsite MRI 10 Years After ACL Reconstruction

— Observational Osteoarthritis, Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention - Observational study with MRI.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee. Basic parameters: 22 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Imaging Post-traumatic Osteoarthritis 10-years After ACL Reconstruction

Overview

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

  • Other No Intervention - Observational study with MRI
    90 minute MRI of the knees

Primary outcome measures

  • Cartilage health status [Time frame: At 10-years after ACL reconstruction]
Secondary outcome measures (1)
  • Patient reported outcomes [Time frame: At 10-years after ACL reconstruction]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT04660955 · 19-573 · R01AR075422

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗