A prospective, double-blinded, randomized controlled trial of an acellular amnion-derived allograft injection comparing 2 doses (1cc and 2cc injection) and a placebo in the treatment of osteoarthritis of the knee

Introduction/Objectives To determine dose-effect of single acellular amnion-derived allograft (AADA) injections of symptomatic knee osteoarthritis (OA). Three treatment arms were included in this clinical investigation: 1cc AADA, 2cc AADA, and saline placebo injections. Improvements from baseline and statistical differences between groups were assessed for each treatment arm. Methods Sixty-one patients with unilateral primary knee OA (grade I through III on the Kellgren-Lawrence grading scale) were randomized into the 3 treatment arms. The patients, the clinician performing the injection, and research staff were blinded to dosage. Patient-reported outcome measures (PROMs) including Knee Injury and Osteoarthritis Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Visual Analog Scale Pain, were recorded at baseline and post-injection intervals up to 12 months, along with adverse events. Results Seventeen patients received 1cc AADA, 28 patients received 2cc AADA, and 16 patients received saline placebo. No adverse events were reported. An ANCOVA analysis revealed no statistically significant difference in PROMs between 1cc and 2cc AADA groups at 6 or 12 months. There were significant differences in mean PROMs between the 1cc and 2cc groups compared to the placebo in KOOS Sport subscore, KOOS Quality of Living subscore, KOOS Jr subscore, and WOMAC pain subscore at 12 months. Conclusions AADA injections appear to be effective and well-tolerated in treatment for symptomatic knee OA. No dose-related effect was observed between 1cc and 2cc groups, however, both groups demonstrated improved outcomes compared to placebo as well as improvements from baseline.