MOON Onsite MRI 10 Years After ACL Reconstruction | NCT04660955

Studies
MOON Onsite MRI 10 Years After ACL Reconstruction

NCT04660955

Sponsor

The Cleveland Clinic

Status

Enrolling by invitation

Last Update Posted

Mar 4, 2026Actual

Enrollment

219Estimated

Phase

Not provided

Conditions

Osteoarthritis, Knee

Interventions

No Intervention - Observational study with MRI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AR075422	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jan 1, 2030Estimated

First Submitted Date

Apr 16, 2020

First Submission Date that Met QC Criteria

Dec 3, 2020

First Posted Date

Dec 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaojuan Li, Lead Principal Investigator, The Cleveland ClinicPrincipal Investigator

Lead Sponsor

The Cleveland ClinicOTHER

Collaborators

Name	Class
Vanderbilt University Medical Center	OTHER
Ohio State University	OTHER
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

219Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention - Observational study with MRI	Other	90 minute MRI of the knees	Controls Patients

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

45 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiaojuan Li, PhD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44125	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided