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Enrolling by Invitation

NCT Number: NCT04660955

MOON Onsite MRI 10 Years After ACL Reconstruction

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.

Enrolling by Invitation

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Key information

Age range

22 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44125, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention - Observational study with MRI

Other

90 minute MRI of the knees

Primary outcomes

  1. Cartilage health status

    Time frame: At 10-years after ACL reconstruction

    Quantitative 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 outcomes

  1. Patient reported outcomes

    Time frame: At 10-years after ACL reconstruction

    Pain score (0-100) evaluated using Knee injury and Osteoarthritis Outcome Score (KOOS)

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Ohio State University
  • Vanderbilt University Medical Center

Registry information

Official study title

Imaging Post-traumatic Osteoarthritis 10-years After ACL Reconstruction

Acronym: MRI

Important dates

Study start
2020
Primary completion
2026
Study completion
2030
First posted
Dec 9, 2020
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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