A pilot study using a single injection of amniotic suspension allograft (ASA) for the treatment of OA demonstrated safety and trends for improved pain and function. To further investigate these effects, a multi-center randomized controlled trial was designed to evaluate the efficacy of ASA injection for the treatment of knee OA symptoms.
200 blinded patients were randomized (across 12 sites) 1:1:1 to: saline, HA, or ASA. Patient reported outcomes (PROs) were completed at baseline and up to 1-year following injection. Changes in Visual Analog Scale (VAS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) PROs from baseline were used to assess efficacy of the injections. Efficacy analysis consisted of ANCOVA in the PROC GLM of the change from baseline between treatment group means where the baseline was included as the covariate at 6 and 12 months.
Patients receiving ASA had significantly lower VAS joint pain scores compared to both HA and saline (p<0.01) at 6 and 12 months. For the KOOS pain subscale, patients receiving ASA had significantly better scores compared to both HA and saline (p<0.05) at 6 and 12 months. ASA treatment resulted in significantly better KOOS symptom scores compared to both HA and saline at 6 and 12 months (p<0.01). For KOOS activities of daily living, ASA treatment resulted in significant increases compared to both HA and saline (p<0.01, p<0.05) at 6 and 12 months. Sports and recreation (S&R) and quality of life (QOL) KOOS subscales resulted in significantly higher scores at 6 months compared to HA (S&R p<0.05; QOL p<0.01) and significantly greater higher scores than HA and saline at 12 months (S&R p<0.05; QOL <0.001).
In this 200-patient clinical trial, subjects receiving ASA treatment showed greater improvement compared to HA and saline, providing evidence for the use of ASA to treat OA symptoms.