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Knee injection after ACL tear may stop arthritis before it starts

NCT ID NCT03968913

Prevention Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether injecting a drug called anakinra into the knee within two weeks of an ACL injury can prevent arthritis that often develops years later. Half of the 32 participants will receive the drug, and half will receive a placebo (salt water). Researchers will track pain, function, and cartilage health using MRI and urine tests for two years after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * patients age 18 to 35 years with closed growth plates as visualized on plain radiographs who participate in cutting and pivoting activities. * we will enroll an equal number of men and women in each treatment group (16 total per group; 8 men, 8 women). * study participants must have an MRI-confirmed ACL injury within 2 weeks of presentation * must elect to undergo bone-patellar tendon-bone (BTB) autograft ACL reconstruction within 45 days of injury * no clinical or MRI evidence of posterior cruciate ligament injury * no more than grade 1 medial collateral ligament injury * no concurrent posterolateral corner injury to the ipsilateral knee Exclusion Criteria: * injury occurring more than 2 weeks prior to enrollment * previous ipsilateral knee injury * multi-ligamentous knee injury * pre-existing or concurrent grade 3 or 4 chondral (cartilage) injuries * previous ipsilateral knee surgery (meniscus tear, ACL tear, chondral injury, etc.) * of note, concurrent acute meniscus injury is NOT an exclusion criteria * active infection * known allergy or adverse reaction to anakinra * intra-articular cortisone injection into either knee within 3 months of injury * prior exposure to IL-1Ra * participation in another clinical drug trial within the 4 weeks before injury * history of any coagulopathy or current anti-coagulation therapy * current malignancy * current inflammatory/rheumatologic disease * current immune-compromised state * current renal failure

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries osteoarthritis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anterior cruciate ligament injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

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