A Multicentre Clinical Investigation to Assess Efficacy and Safety of Intra-articular Injections of Hyaluronic Acid Combined With Chondroitin Sulfate in Knee Osteoarthritis

NACompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

November 28, 2017

Primary Completion Date

September 18, 2018

Study Completion Date

September 18, 2018

Conditions
Osteo Arthritis Knee
Interventions
DEVICE

Hyaluronic Acid Combined With Chondroitin Sulfate

"Subjects' participation in the study will last 26 weeks. The study includes 7 visits that consist of a Screening visit, three treatment visits and three follow-up visits.~Eligible subjects will undergo a Baseline visit (V1 at week 0) during which, after the confirmation of eligibility, assessments and ultrasound evaluation, the study subjects will be treated with the 1st injection of 2%Hyaluronic Acid and 2% chondroitin sulfate Subsequent treatments will be administered at weekly intervals during Visit 2 (V2 at week 1) and Visit 3 (Visit 3 at week 2) after the effectiveness assessments.~Study subjects will return for Follow-up visits 1 month (Visit 4 at week 6), 3 months (Visit 5 at week 14) and 6 months (Visit 6 at week 26) after the last injection"

Trial Locations (5)

Unknown

Revmacentrum MUDr. Mostera,, Brno

Rheumatology, Polyclinic Lesná, Brno

Institute of rheumatology, Prague

University Hospital Motol, Department of Rheumatology of Children and Adults, Prague

Medical Plus, s.r.o, Uherské Hradiště

Sponsors
All Listed Sponsors
lead

Fidia Farmaceutici s.p.a.

INDUSTRY