Efficacy Study of Intra-articular Hyaluronic Acid in the Knee Osteoarthritis

IBSA

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis, Knee

Treatments

Device: Synvisc® ( syringe containing Hylan G-F 20 solution)

Device: Sinovial® (syringe containing sodium hyaluronate solution)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00556608

06CZIFCH/Hai06

Details and patient eligibility

About

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®.

Enrollment

381 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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)
Arthroscopy/osteotomy/surgery in the past 1 year (target knee)
Any surgery scheduled in the next 6 months
Venous or lymphatic stasis in the relevant limb
Skin infection/disease/trauma at the injection site
Systemic or i.a. (target knee) corticosteroids in the past 3 months
I.a. corticosteroids (non-target joint) in the past 4 weeks
Viscosupplementation (target knee) in the past year
Recently started (in the last 3 months) physical therapy (target knee)
Recently (in the last 3 months) started therapy or change in dosage of SYSADOAs
Ongoing anticoagulant therapy
Chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from OA of the target knee
History of allergy or hypersensitivity to hyaluronic acid or paracetamol or avian proteins
Participation in a clinical study in the last 3 months
Pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception
Patients unable to stay in the study for 6 months, non-cooperating, not able to understand