MOON Onsite MRI 10 Years After ACL Reconstruction

Osteoarthritis, Knee Clinical Trial

— MRI  

Official title:

Imaging Post-traumatic Osteoarthritis 10-years After ACL Reconstruction

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04660955
• Other study ID #: 19-573
• Secondary ID: R01AR075422
• Status: Enrolling by invitation
• Start date: January 1, 2020
• Est. completion date: January 1, 2030

Study information

• Verified date: February 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 219
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Ohio State University, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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