MOON Onsite MRI 10 Years After ACL Reconstruction

NeuroTherapia, Inc.

Status: Invitation-only

Conditions: Osteoarthritis, Knee

Treatments: Other: No Intervention - Observational study with MRI

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04660955

R01AR075422 (U.S. NIH Grant/Contract)

19-573

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 estimated patients

Sex: All

Ages: 22 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

219 participants in 2 patient groups

Patients

Description:

Patients who had ACL reconstruction

Treatment:

Other: No Intervention - Observational study with MRI

Controls

Description:

Controls who have no previous knee injury or surgery, no diagnosis of osteoarthritis

Treatment:

Other: No Intervention - Observational study with MRI