Study of Biologic Treatment Using Anakinra to Reduce Osteoarthritis Risk After ACL Injury in Adults Aged 18 to 35

What this Trial Is About

Researchers are studying the effects of biologic therapy to prevent osteoarthritis in active patients who have suffered an anterior cruciate ligament ACL injury. This trial evaluates whether early injections of an interleukin-1 inhibitor, called anakinra, can reduce cartilage damage later in life compared to placebo injections. The study is designed as a randomized, placebo-controlled trial with 32 participants aged 18 to 35 years. Participants will be randomly assigned to one of two groups. Group 1 will receive two injections of sterile saline into the injured knee joint within 1 to 2 weeks of injury and again 3 to 5 days later. Group 2 will receive two injections of anakinra combined with sterile saline at the same time points. Both groups will undergo knee fluid removal arthrocentesis during these procedures and prior to surgery. Ultrasound guidance will be used when feasible to assist with injections. Throughout the study, participants will provide urine and knee joint fluid samples at multiple times before and after surgery for biomarker analysis. They will also complete surveys about knee pain and function before surgery and up to 24 months after. MRI scans, including special cartilage-sensitive sequences, will be performed at 1 and 2 years post-surgery to assess cartilage health. The primary outcomes include measuring cytokine levels and cartilage biomarkers in synovial fluid. The study is double-blinded to patients and outcome assessors to minimize bias.

Biologic Therapy to Prevent Osteoarthritis After ACL Injury