Osteoarthritis, KneeMRINCT04660955
MOON Onsite MRI 10 Years After ACL Reconstruction
An observational study of Osteoarthritis, Knee, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 45 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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
Who cannot join
- History of surgery on contralateral knee
- Afraid of enclosed spaces
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Imaging Post-traumatic Osteoarthritis 10-years After ACL Reconstruction
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- No Intervention - Observational study with MRI
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention - Observational study with MRIOther
90 minute MRI of the knees
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who had ACL reconstruction Receives: Other: No Intervention - Observational study with MRI | |
| Controls | Controls who have no previous knee injury or surgery, no diagnosis of osteoarthritis Receives: Other: No Intervention - Observational study with MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 10-years after ACL reconstruction
Secondary outcomes (1)
Patient reported outcomes
Pain score (0-100) evaluated using Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: At 10-years after ACL reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, Ohio State University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Xiaojuan Li, The Cleveland Clinic
- Investigators
- Xiaojuan Li, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660955
- Sponsor's protocol ID
- 19-573
- Other IDs
- R01AR075422
- Acronym
- MRI
- Status last verified
- Mar 2026
- First submitted
- 16 Apr 2020
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Post-traumatic Osteoarthritis 10-years After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT04660955
- Acronym / sponsor ID
- MRI / 19-573
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, Ohio State University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: No Intervention - Observational study with MRIPatients who had ACL reconstruction |
| Controls | – | Other: No Intervention - Observational study with MRIControls who have no previous knee injury or surgery, no diagnosis of osteoarthritis |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- History of surgery on contralateral knee
- Afraid of enclosed spaces
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention - Observational study with MRI90 minute MRI of the knees | Other | Controls, Patients |
Primary outcome
Cartilage health status
Time frame: 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.
1 secondary outcome
Patient reported outcomes
Time frame: At 10-years after ACL reconstruction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaojuan Li, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cartilage health status (time frame: At 10-years after ACL reconstruction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.