Study to Prevent Cartilage Damage Following Acute Knee Injury.

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Individuals who have had a severe knee injury have an increased risk of developing arthritis of the knee and at a much earlier age than would otherwise be expected. The swelling and inflammation that occur after injury are believed to be responsible for this cartilage damage. The cartilage (material that provides a cushion in the knee) is the primary protection from what is called degenerative arthritis or osteoarthritis. We hope to reduce this swelling and prevent the damage to cartilage that occurs after injury by injecting a medication that blocks one of the proteins responsible for inflammation and cartilage breakdown. This protein is called interleukin-1 and can be inhibited by an interleukin-1 receptor antagonist called anakinra. Anakinra will be injected directly into the injured knee and response to the injection will be measured by symptoms and analysis of cartilage breakdown in the knee fluid and blood.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Onset of injury less than 4 weeks prior to evaluation

• Severe knee injury that requires surgery, including anterior cruciate ligament tear, meniscus tear and chondral injury

• BMI less than 30

• Age 18-30

• Women will have serum pregnancy testing (bHCG) at time of entry and on follow-up evaluation and must agree to use an approved form of contraception during the study period.

Exclusion Criteria:

• Prior signal joint injury requiring medical evaluation

• History of arthritis or rheumatic disease

• History of intra-articular corticosteroid in index joint

• Septic joint

• Evidence of chronic joint disease by plain radiograph

• Fracture or multiple ligament tear

• Pregnancy or lactation

• Inability to give informed consent