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An Initial Injection and a Crossover Injection of Amniotic Suspension Allograft Following Failed Treatment with Hyaluronic Acid or Saline Are Equally Effective in the Treatment of Moderate Symptomatic Knee Osteoarthritis Over 12 Months

Published:July 12, 2022DOI:https://doi.org/10.1016/j.arthro.2022.06.036
An Initial Injection and a Crossover Injection of Amniotic Suspension Allograft Following Failed Treatment with Hyaluronic Acid or Saline Are Equally Effective in the Treatment of Moderate Symptomatic Knee Osteoarthritis Over 12 Months
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      ABSTRACT

      Purpose

      The purpose of this crossover study was to determine the efficacy of amniotic suspension allograft (ASA) for moderate symptomatic knee OA following failed treatment with hyaluronic acid (HA) or saline through 12 months post crossover injection using patient-reported and safety outcomes.

      Methods

      In this multicenter study, 95 patients from a 200-patient single-blind randomized controlled trial were eligible to crossover and receive a single injection of ASA 3 months after failed treatment with HA or saline. Patient-reported outcomes, including Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS), were collected out to 12 months post-crossover to determine pain and function. Radiographs and blood were collected for assessment of changes. Statistical analyses were performed using Mixed Effects Model for Repeated Measures (MMRM).

      Results

      Treatment with ASA following failed treatment with HA or saline resulted in significant improvements in KOOS and VAS scores compared to crossover baseline. There were no differences in radiographic measures or anti-human leukocyte antigen (anti-HLA) serum levels compared to baseline and no severe adverse events reported. Additionally, over 55% of patients were responders at months 3, 6, and 12 as measured by the Outcome Measures in Arthritis Clinical Trials—Osteoarthritis Research Society International (OMERACT-OARSI) simplified responder criteria. There were no significant differences between the original ASA randomized group and crossover cohorts at any of the time points evaluated, suggesting that prior failed treatment with HA or saline did not significantly impact outcomes following treatment with ASA.

      Conclusions

      This study showed that patients who previously failed treatment with HA or saline had statistically significant improvements in pain and function scores following a crossover injection of ASA that was sustained for 12 months, as measured by KOOS and VAS. There were no serious adverse events reported, and the injection was safe.
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      Article Info

      Publication History

      Accepted: June 25, 2022
      Received in revised form: June 22, 2022
      Received: May 24, 2021

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      IRB Information:

      IRB (WIRB) #20142125

      ClinicalTrials.gov: NCT02318511

      Gomoll, Farr: trial design; trial and site PI; data analysis; manuscript preparation

      Archambault: statistics; data analysis, manuscript editing, Sherman, Tabet, Mandelbaum: site PI; data review; manuscript editing

      Kimmerling; Mowry: trial design; data analysis; manuscript preparation

      *All authors reviewed and approved the final manuscript and agree to be accountable for all aspects of the work.

      Acknowledgements: This study was funded by Organogenesis. We would like to thank Anil Chandraker, MD, and his lab for their work on the anti-HLA testing. The ASA study group includes: Kavita Ahuja MD, CRC, Catherine Beckham PA-C, James Borchers MD, David Shane Buggay MD, Jeffrey Clifton MD, Ricardo Colberg MD, Brian Cole MD, MBA, Jeffrey Davis MD, Kristen Davis PA, Jack Farr MD, David Flanigan MD, Samuel Goldstein MD, Andreas Gomoll MD, Kenneth Jaffe MD, Laith Jazrawi MD, Christopher Kaeding MD, Christian Lattermann MD, Robert Magnussen MD, Bert Mandelbaum MD, Rebecca McNair CRNP, Jose Ortega MD, Stephanie Pongracz PA, Seth Sherman MD, Beth Shubin Stein MD, Eric Strauss MD, Sabrina Strickland MD, Samuel Tabet MD, Nikhil Verma MD, Kathleen Weber MD, MS, William Whitley PharmD, Robert Wilson MD, Adam Yanke MD, PhD, and Kenneth Zaslav MD.

      Level of Evidence: II, prospective cohort study

      Identification

      DOI: https://doi.org/10.1016/j.arthro.2022.06.036

      Copyright

      © 2022 Published by Elsevier on behalf of the Arthroscopy Association of North America

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