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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00556608
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

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

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Study Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 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)




Primary Outcome Measures :
  1. Improvement in WOMAC pain subscore from baseline [ Time Frame: 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% [ Time Frame: 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556608


Locations
Show Show 20 study locations
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
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Principal Investigator: Karel PAVELKA, MD Institute of Rheumatology-Na Slupi 4 - 12850 Praha 2 (Czech Republic)
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00556608    
Other Study ID Numbers: 06CZIFCH/Hai06
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pharmaceutical Solutions
Hyaluronic Acid
Hylan
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents