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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04201743
Study type Interventional
Source Illinois Center for Orthopaedic Research and Education
Contact
Status Withdrawn
Phase Phase 4
Start date March 30, 2020
Completion date December 2021

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