MOON Onsite MRI 10 Years After ACL Reconstruction

• Conditions: Osteoarthritis, Knee
• Interventions: Other: No Intervention - Observational study with MRI

• Registration Number: NCT04660955
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 219

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	No Intervention - Observational study with MRI	Controls who have no previous knee injury or surgery, no diagnosis of osteoarthritis
Patients	No Intervention - Observational study with MRI	Patients who had ACL reconstruction

Primary Outcome Measures

Name	Time	Method
Cartilage health status	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 Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States