Preventing osteoarthritis after ACL injuries with biologic therapy
Biologic Therapy to Prevent Osteoarthritis After ACL Injury
This study is testing if a drug called anakinra can help prevent osteoarthritis in young people who have injured their ACL.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT03968913 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 35 with a recent MRI-confirmed ACL injury who plan to undergo ACL reconstruction.
Not a fit: Patients with previous knee injuries or those who have sustained multi-ligamentous injuries will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of osteoarthritis in patients recovering from ACL injuries.
How similar studies have performed: Previous studies in animal models have shown promising results with similar approaches, but this specific application in humans is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.