Abstract
The purpose of this study is to determine the efficacy of amniotic suspension allograft (ASA) compared to hyaluronic acid (HA) and saline at up to 12 months of follow-up through the use of patient-reported outcomes, immunoglobulin levels, and anti-human leukocyte antigen (HLA) levels. Within this multicenter study, 200 patients were randomized 1:1:1 to a single intra-articular injection of saline, HA, or ASA. Patient-reported outcomes, including Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale (VAS) score, were collected at multiple time points (baseline, 1 week, 6 weeks, 3 months, 6 months) out to 12 months to assess improvements in pain and function. Radiographs at baseline and 12 months were taken to determine radiographic changes, while blood was collected at baseline, 6 weeks, and 6 months to determine changes in immunoglobulins and anti-HLA levels. Statistical analyses were performed using last observation carried forward and mixed effects model for repeated measures. Treatment with ASA resulted in significant improvements in KOOS and VAS scores that were maintained through 12 months (P < .05). Treatment with ASA resulted in a 63.2% responder rate at 12 months using the Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International simplified definition. There were no significant differences between groups for radiographic measures in the index knee, immunoglobulins, C-reactive protein, or anti-HLA serum levels (P > .05). The number and type of adverse events (AEs) reported for ASA were comparable to the HA injection group, while no treatment-emergent AEs were reported for the saline group. This randomized controlled trial of ASA vs HA and saline for the treatment of symptomatic knee osteoarthritis demonstrated clinically meaningful improved outcomes with ASA over the controls out to 12 months postinjection. No concerning immunologic or adverse reactions to the ASA injection were identified with regards to severe AEs, immunoglobulin, or anti-HLA levels. Level I, randomized controlled multicenter trial.
Highlights
More than 30.8 million people are estimated to be affected by osteoarthritis (OA) in the United States,[1] with a lifetime risk of 45% for its development,[2] constituting one of the leading causes of disability in adults.[3]
Surgical intervention in the form of knee replacement surgery is increasingly common; the number of patients with OA undergoing knee replacement surgery is expected to rise from 680,150 Americans in 2010 to 1.28 million Americans in 2030.5 concerns regarding the morbidity of the procedure and the increasing burden of potential revision procedures[6] suggest that it should be reserved for those with endstage OA who have exhausted all other attempts at conservative management
Using the high improvement criteria, 50.0%, 25.0%, and 25.0% of patients in the amniotic suspension allograft (ASA), hyaluronic acid (HA), and saline treatment groups were classified as high improvement (P 1⁄4 .0018)
Summary
More than 30.8 million people are estimated to be affected by osteoarthritis (OA) in the United States,[1] with a lifetime risk of 45% for its development,[2] constituting one of the leading causes of disability in adults.[3]. While an increasing number of studies have investigated the effectiveness of platelet-rich plasma for the treatment of OA,[7,8,9] the use of other orthobiologic treatments lacks high-quality supportive data on efficacy and safety. One potential orthobiologic option for the nonoperative management of OA is the use of placental-derived tissues, which were first introduced in the early 1900s to treat burns, ulcers, and other nonhealing wounds,[10] such as corneal ulcers.[11] a weekly intradermal injection of placental-derived autolysate was evaluated in the late
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