Osteoarthritis, Knee Clinical Trial
Official title:
A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft injection for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection.
It is a prospective, double blinded, Randomized Controlled Trial study. Data will be
prospectively collected of all injectable acellular amniotic membrane derived allograft knee
performed at our institute (1 vs 2 mL).
60 subjects will be enrolled in this study. Subjects will be randomized 1:1 in treatment
arms.
Each of the patient will be treated with one time injection to the knee. Methods for
collecting data will be through validated patient-reported outcome tools (KOOS, VAS and WOMAC
questionnaire) that the patient will complete pre-injection and at specified time intervals
after injection: 90 days, 180 days and 365 days.
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