Biologic Therapy to Prevent Osteoarthritis After ACL Injury

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · May 28, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment to help prevent osteoarthritis (OA) in people who have recently injured their anterior cruciate ligament (ACL), which is a common knee injury. Researchers want to understand if an injection of a special protein called anakinra, which helps reduce inflammation, can protect the knee joint from damage that could lead to OA later in life. The study involves 32 participants aged 18 to 35 who have been diagnosed with an ACL injury within two weeks and plan to have surgery within 45 days. Participants will be divided into two groups: one will receive saline injections (placebo), while the other will receive anakinra injections along with the saline.

Participants can expect to have two needle procedures to remove fluid from the knee and receive their injections before their scheduled surgery. Throughout the study, they will report on their pain and function, and undergo urine tests and MRI scans to check for any signs of cartilage damage over time. This trial is open to both men and women and aims to gather important information on how to protect knee health after an ACL injury. It's worth noting that not everyone with an ACL injury will qualify, as specific criteria must be met to ensure safety and effectiveness in the trial.

Gender

ALL

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