CC BY-NC-ND 4.0 · J Knee Surg 2019; 32(11): 1143-1154
DOI: 10.1055/s-0039-1696672
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms

Jack Farr
1  Knee Preservation and Cartilage Restoration Center, OrthoIndy, Indianapolis, Indiana
,
Andreas H. Gomoll
2  Department of Orthopaedic Surgery, Hospital for Special Surgery, New York
,
Adam B. Yanke
3  Section of Cartilage Restoration and Sports Medicine, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
,
Eric J. Strauss
4  Department of Orthopaedic Surgery, NYU Langone Medical Center, New York
,
5  Department of Research and Development, Organogenesis Inc., Birmingham, Alabama
,
ASA Study Group› Author Affiliations
Funding This study was supported by Organogenesis, Inc.
Further Information

Publication History

10 June 2019

03 August 2019

Publication Date:
18 September 2019 (eFirst)

  

Abstract

Placental-derived tissues are a known source of anti-inflammatory and immune modulating factors. Published pilot data on amniotic suspension allograft (ASA) for the treatment of osteoarthritis (OA) demonstrated safety and trends for improved pain and function. A multicenter randomized controlled trial was designed to evaluate the efficacy of symptom modulation with ASA compared with saline and hyaluronic acid (HA) in subjects with knee OA. A total of 200 subjects were randomized 1:1:1 to ASA, HA, or saline, with subjects blinded to their allocation. Changes from baseline of patient-reported outcomes (PROs)—EQ-5D-5L, Knee Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS), Tegner, and Single Assessment Numerical Evaluation (SANE)—were compared between groups. Patients reporting unacceptable pain at 3 months were considered treatment failures and withdrawn from the study. Statistical analysis was completed by comparing changes in PROs from baseline to 3 and 6 months for all groups. Comparison of demographics between treatment groups showed no significant differences between groups. Patients reporting unacceptable pain at 3 months in each group were ASA (13.2%), HA (68.8%), and saline (75%). Patients receiving ASA demonstrated significantly greater improvements from baseline for overall pain (VAS), KOOS pain, and KOOS-activities of daily living scores compared with those in the HA group (3 months) and both groups (6 months). ASA patients had significantly greater improvements in KOOS symptom scores compared with HA and saline at 3 and 6 months, respectively. OMERACT-OARSI responder rates for ASA, HA, and saline groups were 69.1, 39.1, and 42.6%, respectively (p = 0.0007). Subjects receiving ASA treatment showed greater improvements in PROs and fewer patients reported unacceptable pain compared with HA and saline. The evidence presented in this Level I Randomized Controlled Trial suggests that ASA injection is an effective treatment for the nonoperative management of symptomatic knee OA.

For details of the ASA Study Group members, please refer the Acknowledgments section provided at the end of the article.


Supplementary Material