Biologic Therapy to Prevent Osteoarthritis After ACL Injury
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 incr
| Condition(s) | Anterior Cruciate Ligament Injuries |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| 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 injur |
| Who can participate | 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 |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of California, Los Angeles |
| Locations | Los Angeles, California, United States |
| Start date | 2021-09-15 |
| NCT ID | NCT03968913 |
| Official listing | https://clinicaltrials.gov/study/NCT03968913 |