Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis

Clinical Trial Description

Each subject will receive 1 injection (micronized dHACM or placebo) and be evaluated for efficacy and safety during a 12-month observation period. A second injection (open-label access to micronized dHACM) will be offered to all subjects at the 180-day, 270-day, and 365-day time points, it may only be used once. Blinding for the first injection treatment allocation will be maintained until the end of the study. Subjects who receive the open-label access treatment will continue to be followed for 180 days after this second injection, regardless of the time at which treatment was received. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03485157
Study type	Interventional
Source	MiMedx Group, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	March 27, 2018
Completion date	April 19, 2022

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