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Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254).

AbstractOBJECTIVE:
To evaluate the clinical effectiveness of intraarticular IL-1 receptor antagonist (IL-1Ra) for anterior cruciate ligament (ACL) tear.
METHODS:
Eleven patients with acute ACL tear confirmed by magnetic resonance imaging (MRI) were randomized to receive a single intraarticular injection of IL-1Ra (anakinra 150 mg, n = 6) or equal volume of saline placebo (1 ml, n = 5). The double-blinded treatment was administered a mean 2 weeks after injury. Synovial fluid (SF) (n = 9 patients) and sera (all patients) were available at baseline (prior to injection) and immediately prior to surgery (mean 35 days later) and analyzed for SF IL-1α, IL-1β, IL-1Ra and serum hyaluronan (HA), an indicator of synovial inflammation. The primary outcome, standardized Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, was obtained at 0 (baseline), 4, and 14 days after injection.
RESULTS:
Compared with placebo, the IL-1Ra group had substantially greater improvement in key outcomes over 14 days (KOOS pain P = 0.001; activities of daily living P = 0.0015; KOOS sports function P = 0.0026; KOOS quality of life (QOL) P = 0.0048; and total KOOS P < 0.0001). There were no adverse reactions in either group. SF IL-1α (P = 0.05) and serum HA (P = 0.03), but not IL-1β, or IL-1Ra, decreased significantly in the IL-1Ra but not the placebo treated patients. Compared with placebo, IL-1α was borderline significantly different in the IL-1Ra treated group (P = 0.06).
CONCLUSIONS:
Administered within the first month following severe knee injury, IL-1Ra reduced knee pain and improved function over a 2-week interval. This promising proof of concept study provides a new paradigm for studies of acute joint injury and suggests that a larger follow-up study is warranted.
AuthorsV B Kraus, J Birmingham, T V Stabler, S Feng, D C Taylor, C T Moorman 3rd, W E Garrett, A P Toth
JournalOsteoarthritis and cartilage (Osteoarthritis Cartilage) Vol. 20 Issue 4 Pg. 271-8 (Apr 2012) ISSN: 1522-9653 [Electronic] England
PMID22273632 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2012 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
Chemical References
  • Biomarkers
  • Interleukin 1 Receptor Antagonist Protein
Topics
  • Activities of Daily Living
  • Adult
  • Anterior Cruciate Ligament Injuries
  • Biomarkers (metabolism)
  • Female
  • Humans
  • Injections, Intra-Articular
  • Interleukin 1 Receptor Antagonist Protein (administration & dosage, therapeutic use)
  • Knee Injuries (complications, diagnosis, drug therapy, rehabilitation)
  • Magnetic Resonance Imaging
  • Male
  • Pain (drug therapy, etiology)
  • Pilot Projects
  • Quality of Life
  • Recovery of Function
  • Synovial Fluid (metabolism)
  • Trauma Severity Indices
  • Treatment Outcome
  • Young Adult

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