Intra-articular PVA Hydrogel in Knee Osteoarthritis

NACompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

October 1, 2019

Primary Completion Date

May 20, 2020

Study Completion Date

May 20, 2020

Conditions
Knee Osteoarthritis
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.

Trial Locations (1)

21-040

Lubelskie Centrum Diagnostyczne, Świdnik

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Rottapharm Biotech

INDUSTRY

NCT04693104 - Intra-articular PVA Hydrogel in Knee Osteoarthritis | Biotech Hunter | Biotech Hunter