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

Publication ,  Journal Article
Kraus, VB; Birmingham, J; Stabler, TV; Feng, S; Taylor, DC; Moorman, CT; Garrett, WE; Toth, AP
Published in: Osteoarthritis Cartilage
April 2012

OBJECTIVE: 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.

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Published In

Osteoarthritis Cartilage

DOI

EISSN

1522-9653

Publication Date

April 2012

Volume

20

Issue

4

Start / End Page

271 / 278

Location

England

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Trauma Severity Indices
  • Synovial Fluid
  • Recovery of Function
  • Quality of Life
  • Pilot Projects
  • Pain
  • Male
  • Magnetic Resonance Imaging
 

Citation

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Chicago
ICMJE
MLA
NLM
Kraus, V. B., Birmingham, J., Stabler, T. V., Feng, S., Taylor, D. C., Moorman, C. T., … Toth, A. P. (2012). Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254). Osteoarthritis Cartilage, 20(4), 271–278. https://doi.org/10.1016/j.joca.2011.12.009
Kraus, V. B., J. Birmingham, T. V. Stabler, S. Feng, D. C. Taylor, C. T. Moorman, W. E. Garrett, and A. P. Toth. “Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254).Osteoarthritis Cartilage 20, no. 4 (April 2012): 271–78. https://doi.org/10.1016/j.joca.2011.12.009.
Kraus VB, Birmingham J, Stabler TV, Feng S, Taylor DC, Moorman CT, et al. Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254). Osteoarthritis Cartilage. 2012 Apr;20(4):271–8.
Kraus, V. B., et al. “Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254).Osteoarthritis Cartilage, vol. 20, no. 4, Apr. 2012, pp. 271–78. Pubmed, doi:10.1016/j.joca.2011.12.009.
Kraus VB, Birmingham J, Stabler TV, Feng S, Taylor DC, Moorman CT, Garrett WE, Toth AP. Effects of intraarticular IL1-Ra for acute anterior cruciate ligament knee injury: a randomized controlled pilot trial (NCT00332254). Osteoarthritis Cartilage. 2012 Apr;20(4):271–278.
Journal cover image

Published In

Osteoarthritis Cartilage

DOI

EISSN

1522-9653

Publication Date

April 2012

Volume

20

Issue

4

Start / End Page

271 / 278

Location

England

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Trauma Severity Indices
  • Synovial Fluid
  • Recovery of Function
  • Quality of Life
  • Pilot Projects
  • Pain
  • Male
  • Magnetic Resonance Imaging