MOON Onsite MRI 10 Years After ACL Reconstruction (MRI)

Imaging Post-traumatic Osteoarthritis 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: No Intervention - Observational study with MRI

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.

• Study Type: Observational
• Enrollment (Estimated): 219

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44125
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This patient cohort include patients who had ACL reconstruction 10 years ago and were recruited in the previous MOON onsite study based on the inclusion criteria listed above.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients who had ACL reconstruction	Other: 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	Other: No Intervention - Observational study with MRI; 90 minute MRI of the knees

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cartilage health status	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.	At 10-years after ACL reconstruction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcomes	Pain score (0-100) evaluated using Knee injury and Osteoarthritis Outcome Score (KOOS)	At 10-years after ACL reconstruction

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Vanderbilt University Medical Center; Ohio State University
• Investigators: Principal Investigator: Xiaojuan Li, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: 19-573; R01AR075422 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No