Efficacy Evaluation of Intra-articular Hyaluronic Acid (Sinovial®) vs Synvisc® in the Treatment of Symptomatic Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study

IBSA Institut Biochimique SA20 sites in 6 countries381 target enrollmentNovember 2007

ConditionsOsteoarthritis, Knee

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: IBSA Institut Biochimique SA
Enrollment: 381
Locations: 20
Primary Endpoint: Improvement in WOMAC pain subscore from baseline
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

May 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

IBSA Institut Biochimique SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age between 40 and 80 years
•Primary knee OA of the medial or lateral femoro-tibial compartment
•Symptoms for at least 3 months
•Diagnosis according to ACR criteria
•Kellgren \& Lawrence radiological grade 2-3
•Patients who failed to respond sufficiently (not responders) to analgesics and/or NSAIDs taken regularly or responders intolerant to the regular use of analgesics and/or NSAIDs.
•Mean WOMAC pain subscore at the target knee \>= 40 mm and \< 80 mm on a VAS at baseline after wash-out from analgesics/NSAIDs· If bilateral knee OA: definition of the most symptomatic joint at screening based on patient's evaluation and Investigator's clinical judgment and mean WOMAC pain subscore at baseline in the contra-lateral knee \< 30 mm
•Written informed consent
•Subject able to understand, co-operative and reliable

Exclusion Criteria

•BMI \>= 32 kg/m2
•Secondary (post-traumatic) knee OA
•Predominantly patello-femoral pain/syndrome
•No remaining joint space width
•Symptomatic hip OA or other interfering health condition
•Severe varus/valgus deformity (\>15°)
•History/present evidence of (target knee): inflammatory, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropaties; osteo-articular pathologies differing from arthrosis; articular fracture; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations.
•Concomitant rheumatic disease
•Significant injury to the target knee in the last 6 months
•Previous joint replacement/arthroplasty (target knee)

Outcomes

Primary Outcomes

Improvement in WOMAC pain subscore from baseline

Time Frame: to week 26

Secondary Outcomes

Change in WOMAC OA Index total score and pain, function and stiffness subscores;Change in Lequesne's algofunctional index; Change in global pain (visit assessment); Change in global status by the patient;Change in global status by the Investigator;SPID%(26 weeks)