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New treatment option for Anterior Cruciate Ligament Injuries
Official title Biologic Therapy to Prevent Osteoarthritis After ACL Injury
ClinicalTrials.gov ID: NCT03968913
What this study is testing
What is Anakinra injection?
Anakinra injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for anterior cruciate ligament injuries.
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
- 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.
- 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's taking place
- Los Angeles, California, United States
Compensation & support
Some study costs may be covered.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.