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Biologic Therapy to Prevent Osteoarthritis After ACL Injury

This study is testing if an injection of anakinra, a drug that blocks a protein called interleukin-1 (IL-1) which can cause arthritis, can help prevent osteoarthritis (OA) after an Anterior Cruciate Ligament (ACL) injury. Researchers will compare anakinra injections to sterile saline (salt water) injections in the knee. They want to see if anakinra can reduce levels of certain proteins (cytokines and cartilage biomarkers) in the knee fluid that are linked to OA. You might be able to join if you are between 18 and 35 years old, have an MRI-confirmed ACL injury within two weeks, and are planning to have surgery. The study aims to enroll 32 participants, with an equal number of men and women.

Study design
This study is interventional and plans to enroll 32 participants, divided into two groups who will receive either anakinra or sterile saline injections.
What's involved
You would have two knee fluid aspirations and two injections (either anakinra or sterile saline) before surgery.
Compensation
Not stated in the trial record.
Follow-up
Synovial fluid will be collected within 2 weeks of injury, 3-5 days after the initial injection, at the time of surgery, and approximately 10 days after surgery.

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NCT03968913

Biologic Therapy to Prevent Osteoarthritis After ACL Injury

Recruiting
EARLY_PHASE1Ages 18–35InterventionalTreatment
University of California, Los Angeles
~32 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:Anakinra injectionsterile saline injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cytokine level analysis of synovial fluid
Measured over Synovial fluid will be collected within 2 weeks of injury and at approximately 3 to 5 days after the initial injection, at the time of surgery and approximately 10 days after surgery.
+1 more outcome measured

Conditions

Anterior Cruciate Ligament Injuries

Explore related trials

Injury of anterior cruciate ligamentOsteoarthritis

Where it's being run

1 sites across 1 states
California1

Who to contact

Adreanne Rivera
[email protected]
310.794.0213
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.)
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

What this trial measures

  • Cytokine level analysis of synovial fluidSynovial fluid will be collected within 2 weeks of injury and at approximately 3 to 5 days after the initial injection, at the time of surgery and approximately 10 days after surgery.

    Synovial fluid samples will be analyzed for a change in the level of interleukin-1 and interleukin-1 receptor antagonist levels using enzyme-linked immunosorbent assays (ELISA).

  • Cartilage biomarker analysis of synovial fluidSynovial fluid will be collected within 2 weeks of injury and at approximately 10 days after ACL injury, at the time of surgery and approximately 10 days after surgery.

    Synovial fluid samples will be analyzed for a change in the level of cartilage breakdown metabolites using enzyme-linked immunosorbent assays (ELISA). Specifically we will test for cartilage tissue breakdown products according to Osteoarthritis Research Society International guidelines including testing for type II Collagen Helical Peptide, C-telopeptide of type II collagen breakdown, sulfated glycosaminoglycan, cartilage oligomeric matrix protein, matrix metalloproteinases 1, 3 and 9 (MMP-1, MMP-3, and MMP-9), and tumor necrosis factor-inducible gene 6.