Amniotic Tissue Injections Are an Effective Alternative to Corticosteroid Injections for Pain Relief and Function in Patients With Severe Knee Osteoarthritis: A Double-Blind, Randomized, Prospective Study.

Abstract

Introduction: The use of corticosteroid injections for short-term pain relief for knee osteoarthritis can have deleterious adverse effects. Amniotic tissue has shown promise in vitro; therefore, this study compared a morcellized injectable amniotic tissue allograft to corticosteroid injection.

Methods: Eighty-one patients with symptomatic severe knee osteoarthritis (Kellgren-Lawrence grade 3 to 4) were prospectively randomized to either a double-blinded single injection of BioDRestore (Integra LifeSciences; n = 39) or triamcinolone acetonide (n = 42). Knee Injury and Osteoarthritis Outcome Score (KOOS), Single Alpha Numeric Evaluation, visual analog scale (VAS) pain, Lysholm Rating, and Veterans-Rand-12 scales at baseline, 6 weeks, 3, 6, and 12 months were analyzed.

Results: No differences were observed in adverse reactions or patient reported outcomes (PROs); however, a notable continued improvement was found in the amnion group from 6 weeks to 1 year for Single Alpha Numeric Evaluation, Lysholm, and KOOS Symptoms, Pain, activities of daily living [ADL], QofL. The minimal clinically important difference (MCID) was met for Lysholm, KOOS ADL, and KOOS pain.

Discussion: Both amnion and steroid injections showed an initial improvement in pain relief and function at 6 weeks; however, more patients in the amniotic tissue group maintained pain relief and function at the 1-year follow-up. The mixed results suggest that amniotic tissue injections may be a safe and effective alternative to corticosteroid injections.