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Study to Prevent Cartilage Damage Following Acute Knee Injury.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332254
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Injury Drug: Anakinra Phase 1 Phase 2

Detailed Description:

Osteoarthritis is highly prevalent with significant impact on health care utilization and personal suffering. Injury predisposes to OA even after surgical correction (1, 2). Definitive therapy for established OA is lacking and current treatments are increasingly questioned with regard to long-term safety. Interleukin-1 is instrumental in OA pathogenesis (3-5). Recent studies by Chevalier demonstrated that intra-articular use of IL-1ra was safe in patients with established OA (6). We hope to show that IL-1ra will provide symptomatic benefit after knee injury as well as decreasing cartilage breakdown.

The trial will consist of trial administering 150mg of Anakinra, or placebo, within 30 days of an acute knee injury that requires surgical repair. We hypothesize that higher IL-1 in synovial fluid after injury will predict greater symptomatic response to IL-1ra. Outcome measures will be functional and pain assessments at regular intervals before and after surgery (7, 8). Cartilage catabolism will be assessed with two primary measures. First we will assess degree of chondropathy via direct cartilage visualization and scoring at the time of arthroscopic repair (9). Secondly, the impact of IL-1ra on the inflammatory milieu will be determined through analysis of serum and synovial fluid cytokine levels and cartilage biomarkers at enrollment and again at the time of surgical repair.

The impetus for this study is based on previous work done in animal models of OA, showing prevention of cartilage damage following surgically induced ACL injury (10-12). We believe that intra-articular delivery of anakinra within a short time following knee injury will improve patient function and pain reporting and will also prevent chondropathy that results from injury.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IL-1ra for Prevention of Chondropathy Following Knee Injury
Study Start Date : March 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arm Intervention/treatment
Experimental: 1
Intra-articular IL-1Ra
Drug: Anakinra
150 mg IL1Ra ia x1 vs saline ia x1
Other Name: Kineret

Placebo Comparator: 2
Intra-articular saline
Drug: Anakinra
150 mg IL1Ra ia x1 vs saline ia x1
Other Name: Kineret

Primary Outcome Measures :
  1. pain [ Time Frame: 4 and 30 days ]

Secondary Outcome Measures :
  1. chondropathy score [ Time Frame: 30-60 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00332254

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United States, North Carolina
Duke University Sports Medicine Clinic
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Study Chair: Virginia B Kraus, MD, PhD Duke University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Duke University Identifier: NCT00332254    
Other Study ID Numbers: Pro00014439
7939-05-11 ( Other Identifier: Duke IRB# )
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: January 2008
Keywords provided by Duke University:
Anterior cruciate ligament tear
Meniscus tear
Chondral injury
Additional relevant MeSH terms:
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Wounds and Injuries
Knee Injuries
Leg Injuries
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents