NCT03968913 Biologic Therapy to Prevent Osteoarthritis After ACL Injury
| NCT ID | NCT03968913 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, Los Angeles |
| Condition | Anterior Cruciate Ligament Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2021-09-15 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2021-09-15 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Anterior cruciate ligament (ACL) injuries are extremely common. On average, 50% of individuals suffering an ACL injury will develop radiographic osteoarthritis (OA) 10 to 20 years after injury. Unfortunately, ACL reconstruction does not prevent risk of future OA. Interleukin-1 (IL-1) levels in the human knee joint increase transiently after an ACL injury. In animal experiments, if interleukin-1 levels are increased in the joint, this alone causes arthritis to occur. Interleukin-1 receptor antagonist (IL-1Ra) is a naturally occurring inhibitor of IL-1. However, in ACL injuries the balance of these two proteins is disturbed transiently after injury, with the effects of IL-1 dominating this balance. In a large animal model of ACL injury, injection of IL-1Ra into the knee joint after ACL injury significantly decreased the amount of arthritis that was later observed. Thus, the investigators hypothesize that early injection of IL-1 inhibitor (IL-1Ra) into the knee joint of patients suffering recent ACL injury will decrease the incidence of cartilage damage later in life. After appropriate IRB approval, a total of 32 active patients will be randomized into one of two treatment groups. Group 1 will receive removal of the knee joint fluid (aspiration of hemarthrosis) using a needle and syringe within 1 to 2 weeks of injury. Following aspiration of the knee joint, an injection of 5 milliliters (mls) of sterile saline (as a placebo control) will be administered. In addition, a second knee aspiration procedure and an injection of 5mls of sterile saline into the injured knee joint will be performed at 3 to 5 days after the initial injection. Group 2 will receive aspiration of the knee hemarthrosis as described in group 1 as well as intra-articular administration of 150mg (\~5mls) of anakinra (rhIL-1Ra) within 1 to 2 weeks of ACL injury. In addition, a second knee aspiration and intra-articular administration of 150mg (\~5mls) of anakinra (rhIL-1Ra) will be performed at 3 to 5 days after the initial injection. Thus, all patients in this randomized placebo-controlled trial will undergo two injection procedures prior to surgery. Investigators will analyze subjects self-reported function and pain scores as well as urinary levels of cartilage breakdown products over time. Additionally, MRI studies will be used to compare MRI findings among patients in these 2 treatment groups. Urine samples will be obtain prior to surgery, at the time of surgery and at multiple time points after surgery (3, 6, 9, 12 and 24 months after surgery). Subjective outcome measure assessments (surveys) will be completed by participants prior to surgery and then again at 6, 9, 12 and 24 months post-operatively. MRI studies will be obtained at 1 year and 2 years following surgery. Additional, MRI studies at time points are optional and highly encouraged. These additional MRIs are at no cost to the patient.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03968913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Anterior Cruciate Ligament Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03968913 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03968913 currently recruiting?
Yes, NCT03968913 is actively recruiting participants. Contact the research team at adreannerivera@mednet.ucla.edu for enrollment information.
Where is the NCT03968913 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT03968913 clinical trial?
NCT03968913 is sponsored by University of California, Los Angeles. The trial plans to enroll 32 participants.