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

Contura3 sites in 1 country238 target enrollmentMay 15, 2019

ConditionsOsteoarthritis, Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Contura
Enrollment: 238
Locations: 3
Primary Endpoint: Comparing one injection of PAAG-OA with one injection of Synvisc-One on pain over 6 months in subjects with knee osteoarthritis
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 15, 2019

End Date

November 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Contura

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed and dated informed consent form
•Stated willingness to comply with all study procedures and availability for the duration of the study
•Male or female, aged ≥ 40 years
•Clinical diagnosis of knee OA American College of Rheumatology criteria confirmed by radiology
•Definite radiographic OA in the most symptomatic knee (target knee) at mild to moderate-stage (Kellgren-Lawrence grades 2 or 3)
•Stable dose of analgesics for the past four weeks
•NRS (11 points (0-10) pain intensity numerical rating scale) ≥ 4 in target knee, during the past week when walking
•Body Mass Index (BMI) between 20-35
•For females of reproductive potential: use of adequate contraception must be used throughout the trial

Exclusion Criteria

•Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation
•Contraindications to PAAG-OA or Synvisc-One®, according to IB or Instruction for Use (IFU)
•Previous intra-articular injection of polyacrylamide gel in the target knee
•Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months
•Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability
•Other diseases in target knee than osteoarthritis
•Intra-articular injection of any substance other than hyaluronic acid (e.g. corticosteroids) in the target knee within the last 3 months
•Acute serious infection of any region that required hospital care or intravenous antibiotic treatment within the last 30 days, or oral antibiotic treatment within the last 14 days
•Skin disease or infections in the area of the injection site
•Infected or severely inflamed knees