NCT04045431

Treatment of Knee Osteoarthritis With PAAG-OA

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Contura · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	PAAG-OA	Intra-articular injection of 6ml PAAG-OA in the target knee (incl. five (5) years follow-up) period.
DEVICE	Synvisc-One	Intra-articular injection of 6ml Synvisc-One in the target knee

Timeline

• Start date: 2019-05-15
• Primary completion: 2020-10-01
• Completion: 2026-11-30
• First posted: 2019-08-05
• Last updated: 2024-01-08

Locations

3 sites across 1 country: Denmark