Amniotic allograft suspension injection for knee osteoarthritis was safe, efficacious
Researchers observed significant improvement in pain and function among patients with knee osteoarthritis who received a single injection of amniotic suspension allograft vs. patients who received a control injection of hyaluronic acid or saline.
For the 12-month multicenter trial, the results of which were presented at the virtual American Academy of Orthopaedic Surgeons Annual Meeting, Jack Farr, MD, FAAOS; Andreas H. Gomoll, MD, FAAOS; Katie C. Mowry, PhD, and colleagues evaluated the efficacy of amniotic suspension allograft (ASA) compared to hyaluronic acid or saline in 200 patients who were randomized 1:1:1 to the three treatment groups. In addition, researchers evaluated KOOS and VAS scores following injection, which were the patient-reported outcomes, and performed safety testing for and evaluated patient response to ASA.
“[Our] study demonstrated a statistically significant improvement in pain and function at 6 months for patients receiving a single knee injection of amniotic suspension allograft when compared to those receiving controls of saline or hyaluronic acid. This cohort will continue to be observed and a future publication will review the 12-month patient-reported outcomes. It is hoped that with these positive findings, additional high-level studies will follow,” Farr, Gomoll and Mowry told Healio Orthopedics.
Patients in the ASA injection group showed significant improvement in KOOS pain, symptoms, activities of daily living, sports and recreation, and quality of life vs. patients in the hyaluronic acid or saline groups at 12 months after treatment, according to the results. In addition, compared to the hyaluronic and saline groups, findings showed patients treated with ASA had significantly improved VAS overall pain, as well as improved pain during both strenuous and sedentary work and usual activities of daily living.
Blinded patients in the trial who reported unacceptable pain relief were significantly different in the ASA (9, 13.2%), hyaluronic acid (44, 68.8%) and saline (51, 75.0%) groups, based on the findings.
Concerning safety of the ASA injections, blood panels showed neither immunoglobulins nor anti-human leukocyte antigen antibodies increased significantly in patients in response to ASA treatment. – by Susan M. Rapp
Farr J, et al. ePaper 635. Presented at: American Academy of Orthopaedic Surgeons Annual Meeting; March 24-28, 2020 (meeting canceled).
Farr J, et al. J Knee Surg. 2019;doi:10.1055/s-0039-1696672.
Disclosures: Farr and Gomoll report they are paid consultants for study sponsor Organogenesis. Mowry reports she is an employee of Organogenesis.