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Interleukin-1 Inhibitor

Biologic Therapy for Osteoarthritis Prevention After ACL Injury

Phase < 1

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

no more than grade 1 medial collateral ligament injury

patients age 18 to 35 years with closed growth plates as visualized on plain radiographs who participate in cutting and pivoting activities.

Must not have

multi-ligamentous knee injury

current malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surveys will be obtained prior to surgery and then at 3, 6, 9, 12 and 24 months following surgery

Summary

This trial is testing whether or not a common injury, an ACL tear, can be prevented from turning into arthritis by using a naturally occurring protein.

Who is the study for?

This trial is for men and women aged 18-35 with a recent ACL injury who plan to have ACL reconstruction surgery within 45 days. They must not have severe knee injuries besides the ACL, no history of certain diseases or conditions, and no prior treatments that could interfere with the study.

What is being tested?

The trial tests if injecting Anakinra (a biologic therapy) into the knee after an ACL injury can prevent osteoarthritis. Participants are randomly placed in two groups: one gets Anakinra injections, while the other receives placebo saline injections before their surgery.

What are the potential side effects?

Anakinra may cause reactions at the injection site, increased risk of infection due to immune system suppression, headaches, nausea, and potential allergic reactions in those sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My knee injury is minor.

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I am between 18 and 35 years old and engage in sports that involve sudden direction changes.

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My ACL injury was confirmed by an MRI less than 2 weeks ago.

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I do not have an injury to the outer back part of my same-side knee.

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My knee's back ligament is not injured, according to tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have multiple torn ligaments in my knee.

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I currently have cancer.

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I have a blood clotting disorder or am on blood thinners.

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I have previously been treated with IL-1Ra.

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I am experiencing kidney failure.

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I have an ongoing inflammatory or rheumatologic condition.

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I have severe cartilage damage.

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I have had surgery on the same knee before.

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I do not have any current infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surveys will be obtained prior to surgery and then at 3, 6, 9, 12 and 24 months following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~surveys will be obtained prior to surgery and then at 3, 6, 9, 12 and 24 months following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and surveys will be obtained prior to surgery and then at 3, 6, 9, 12 and 24 months following surgery for reporting.