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

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

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.

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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