Anterior Cruciate Ligament Injuries study: Anakinra injection
Official title Biologic Therapy to Prevent Osteoarthritis After ACL Injury
ClinicalTrials.gov ID: NCT03968913
What this study is testing
What is Anakinra injection?
An investigational injectable medicine being studied for treating anterior cruciate ligament injuries. It is designed to block interleukin‑1 activity in the knee joint.
Also referred to as Kineret.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if giving an IL‑1 inhibitor soon after an ACL injury lowers the chance of cartilage damage later in life.
- Who it's for
- Adults who have recently had an ACL injury and are scheduled for ACL surgery.
- What's involved
- Participants will have two knee aspiration and injection procedures: one with a placebo and one with the IL‑1 blocker (anakinra). They will also give urine samples, complete pain and function surveys, and get MRIs of the knee at scheduled times.
- Time commitment
- The study lasts about 2 years after surgery, with visits for surveys at 6, 9, 12, and 24 months, urine samples at several time points, and MRIs at 1 and 2 years.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
Compensation & support
Some study-related costs may be covered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.