Clincosm LogoSign in Get a demo

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

Sponsor
IBSA Institut Biochimique SA (Industry)
Overall Status
Completed
CT.gov ID
NCT00556608
Collaborator
(none)
381
Enrollment
20
Locations
2
Arms
30
Duration (Months)
19.1
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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®.

Condition or Disease Intervention/Treatment Phase
  • Device: Sinovial® (syringe containing sodium hyaluronate solution)
  • Device: Synvisc® ( syringe containing Hylan G-F 20 solution)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
381 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sinovial

3 intra-articular injections of Sinovial®

Device: Sinovial® (syringe containing sodium hyaluronate solution)
2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.
Other Names:
  • Sinovial®: Class III medical device(CE mark n° 0499)

    		•
    Active Comparator: Sinvisc

    Device: Synvisc® ( syringe containing Hylan G-F 20 solution)
    2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.
    Other Names:
  • Synvisc®: class III medical device (CE mark n° 0088)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in WOMAC pain subscore from baseline [to week 26]

    Secondary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Interni hemato-onkologická klinika, Fakultní nemocnice Brno - Bohunice Czech Republic 63900
    2 ARTHROMED s.r.o. Pardubice Czech Republic 53002
    3 Institute of Rheumatology Praha Czech Republic 12850
    4 Centrum léčby pohybového aparátu spol. s.r.o. Praha Czech Republic 19061
    5 University Hospital Centre Bois-Guillaume Bois Guillaume France 76230
    6 University Hospital Centre of Limoges - Rheumatology Service Limoges Cedex France 87042
    7 Orthopädische Universitätsklinik und Poliklinik der RWTH Aachen Aachen Germany 52074
    8 Nova clinic Biberach an der Riss Germany 88400
    9 Orthopädische Praxis Stockach Germany 78333
    10 Sezione Dipartimentale a valenza provinciale di Reumatologia - AzUSL 8 Arezzo Italy 52100
    11 Ospedale Privato Accreditato Nigrisoli Bologna Italy 40138
    12 Medicina e Traumatologia dello Sport - AzUSL 2 Lucca Lucca Italy 55100
    13 Unità Operativa di Reumatologia - Istituto Ortopedico Gaetano Pini Milano Italy 20122
    14 Rheumatology Unit Santa Chiara Hospital Pisa Italy 56126
    15 Unità Operativa di Reumatologia - Az. Ospedaliera Universitaria Senese - Policlinico "Le Scotte" Siena Italy 53100
    16 F.D. Roosevelt's University Hospital Banská Bystrica Slovakia 975 17
    17 Romjan s.r.o. Bratislava Slovakia 831 03
    18 National Institute of Rheumatic Diseases Piest'any Slovakia 921 12
    19 Rheumatology Clinic, Reumaglobal s.r.o Trnava Slovakia 917 01
    20 Department of Rheumatology and Institute of Physical Medicine - Zurich University Zürich Switzerland 8091

    Sponsors and Collaborators

    • IBSA Institut Biochimique SA

    Investigators

    • Principal Investigator: Karel PAVELKA, MD, Institute of Rheumatology-Na Slupi 4 - 12850 Praha 2 (Czech Republic)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    IBSA Institut Biochimique SA
    ClinicalTrials.gov Identifier:
    NCT00556608
    Other Study ID Numbers:
    • 06CZIFCH/Hai06
    First Posted:
    Nov 12, 2007
    Last Update Posted:
    Dec 4, 2012
    Last Verified:
    Nov 1, 2012
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Pharmaceutical Solutions
    Hyaluronic Acid
    Hylan

    Study Results

    No Results Posted as of Dec 4, 2012