IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions
Condition: Anterior Cruciate Ligament Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: anakinra (150mg); Saline intraarticularly
Intervention description: intraarticular administration; intraarticular administration
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 14 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      Injury to the knee during sports participation often involves partial or full detachment of
      the anterior cruciate ligament (abbreviated as ACL). ACL tears cause pain, swelling and
      inflammation. While the swelling and inflammation usually goes away in time, individuals with
      ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often
      surgery can repair or replace the ACL within the joint, allowing individuals the ability to
      walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the
      knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for
      reasons which are not well understood.

      In this research study, the investigator hopes to reduce the initial pre-operative pain. The
      reduction of pain will allow for earlier movement of the knee joint and preparation for
      surgery. The investigator is interested to see if the use of Kineret does decrease the risk
      of developing arthritis in individuals with ACL injuries by treating them within 28 days
      after their injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute ACL Tear and Painful Effusions

          -  Signed and dated combined informed consent/HIPAA form and if a minor, a signed assent.

          -  Willingness to comply with all study procedures and availability for the duration of
             the study

          -  For females of reproductive potential: use of highly effective contraception.

          -  Currently participating in a sporting activity

          -  Documentation of closed growth plates as noted on the screening x-ray

        Exclusion Criteria:

          -  underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis etc)

          -  have been diagnosed with hepatitis B or tuberculosis

          -  currently have an infections, including infection of the skin, or have signs and
             symptoms of an infection, including fever.

          -  any abnormalities in their white blood cell counts

          -  have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs

          -  other major medical condition requiring treatment with immunosuppressant or modulating
             drugs.

          -  A history of chronic use of non-steroidal anti-inflammatory drugs

          -  Currently taking immunosuppressant medication, including oral and parenteral
             corticosteroids (topical and stable dose inhaled corticosteriods are acceptable)

          -  Females who are pregnant or breastfeeding

          -  Received a "live" vaccine (smallpox, MMR (measles, mumps and rubella), flu, polio,
             typhoid, chicken pox, yellow fever, herpes zoster) 4 weeks prior to screening.

          -  A history of bleeding disorders or are taking any blood thinning medications, aspirin
             or other medications affecting blood clotting.

          -  Previous exposure or allergic reaction to anakinra

          -  Allergy to latex or tape

          -  Allergy to Kineret or have had a reaction to any local or general anesthesia

          -  prior knee surgery (contralateral)

          -  have received any investigational drug with 4 weeks of study Visit 1