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Treatment of Knee Osteoarthritis With PAAG-OA — ROSA  

Osteoarthritis, Knee Clinical Trial

Official title:
A Multi-centre Randomized, Controlled, Double-blind Clinical Investigation of Intra-articular Polyacrylamide Hydrogel in Subjects With Knee Osteoarthritis Followed by an Open Label Extension Study

Clinical Trial Summary

This is a multi-center, randomized, double-blind clinical investigation to compare the effectiveness of intra-articular polyacrylamide hydrogel (PAAG-OA) and a hyaluronic acid, Synvisc-One to induce symptomatic benefit in subjects with knee osteoarthritis.

Clinical Trial Description

The trial is designed as a multi-center, randomised, controlled, double-blind, and parallel-group trial spanning over 12 months with outcome assessments at baseline, 1, 3, 6 and 12 months incl. follow-up period between 2-5 years. Primary endpoint at 6 months. The trial is designed to compare effectiveness and safety of injection of PAAG-OA and Synvisc-One® in participants with knee OA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04045431
Study type Interventional
Source Contura
Contact
Status Active, not recruiting
Phase N/A
Start date May 15, 2019
Completion date November 30, 2026
View Details
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