Preventing osteoarthritis after ACL injuries with biologic therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of anakinra, an interleukin-1 receptor antagonist, to prevent the development of osteoarthritis in patients who have suffered an anterior cruciate ligament (ACL) injury. The study will enroll 32 participants aged 18 to 35 who will be randomized into two groups: one receiving saline injections as a placebo and the other receiving anakinra injections following knee aspiration. Both groups will undergo two knee aspiration and injection procedures within two weeks of their injury. The goal is to assess whether early intervention with anakinra can reduce the risk of future osteoarthritis.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Adreanne Rivera
• Email: adreannerivera@mednet.ucla.edu
• Phone: 310.794.0213

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.