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Intra-articular PVA Hydrogel in Knee Osteoarthritis

NCT04693104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-01-05

No results posted yet for this study

Summary

This multicentre, prospective, randomized, double-blind, active-controlled, parallel group clinical investigation is aimed to assess the safety and the clinical performance over 6 months of a single intra-articular injection of PVA Hydrogel, novel polyvinyl alcohol preparation, as compared to hyalan G-F20, (Synvisc-One®) one of the most commonly used and best performing hyaluronic acid based products, in patients with symptomatic knee osteoarthitis (OA).

Conditions

Interventions

DEVICE

PVA Hydrogel

PVA Hydrogel will be supplied in 2 mL sterile and endotoxins-free pre-filled syringes containing a biocompatible polyvinyl alcohol crosslinked (PVA CL, main component) and buffered water for injections.

DEVICE

Synvisk-One®

Synvisc One® (comparator) will be supplied in a 6 mL sterile and non-pyrogenic syringe containing containing Hylan polymers (hylan A + hylan B) (main component), sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate and water for injections.

Sponsors & Collaborators

  • Rottapharm Biotech

    lead INDUSTRY

Principal Investigators

  • Tomaz Blicharski · Lubelskie Centrum Diagnostyczne, Swidnik, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-05-20
Completion
2020-05-20

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04693104 on ClinicalTrials.gov