MOON Onsite MRI 10 Years After ACL Reconstruction

NCT ID: NCT04660955

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2030-01-01

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

Patients who had ACL reconstruction

No Intervention - Observational study with MRI

Intervention Type OTHER

90 minute MRI of the knees

Controls

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

No Intervention - Observational study with MRI

Intervention Type OTHER

90 minute MRI of the knees

Interventions

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No Intervention - Observational study with MRI

90 minute MRI of the knees

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Xiaojuan Li

Lead Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaojuan Li, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R01AR075422

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-573

Identifier Type: -

Identifier Source: org_study_id

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