Biologic Therapy to Prevent Osteoarthritis After ACL Injury

Plain-language summary

This study is examining injections of the drug Anakinra to help prevent osteoarthritis (joint degeneration) after an anterior cruciate ligament (ACL) injury, compared with sterile saline injection. People aged 18 to 35 with an MRI-confirmed ACL injury who are scheduled for surgery are eligible. The study is being carried out in Early Phase 1 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Early Phase 1

Status

Recruiting

Sponsor

University of California, Los Angeles

Intervention

Anakinra injection, sterile saline injection

Start date

9/15/2021

Estimated completion

1/30/2027

Countries

United States

Related genes

Locations

• Los Angeles, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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