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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

      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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