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An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee

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

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

Clinical Trial Details
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Status Withdrawn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
View Details
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