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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT00556608
First received: November 9, 2007
Last updated: December 3, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Osteoarthritis, Knee
Device: Sinovial® (syringe containing sodium hyaluronate solution)
Device: Synvisc® ( syringe containing Hylan G-F 20 solution)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • Improvement in WOMAC pain subscore from baseline [ Time Frame: to week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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% [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 381
Study Start Date: November 2007
Study Completion Date: May 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Synvisc®: class III medical device (CE mark n° 0088)

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556608

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00556608     History of Changes
Other Study ID Numbers: 06CZIFCH/Hai06
Study First Received: November 9, 2007
Last Updated: December 3, 2012
Health Authority: Czech Republic: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ethics Committee
Switzerland: Ethikkommission

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014