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Effectiveness Study of Hylan G-F 20 to Preserve Cartilage in Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT00393393
Recruitment Status : Unknown
Verified October 2006 by Cabrini Medical Centre.
Recruitment status was:  Recruiting
First Posted : October 27, 2006
Last Update Posted : October 27, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
That Hylan G-F 20 may act to protect cartilage from the expected degree of degradation over a 12 month period in subjects with moderate to marked osteoarthritis of the knee

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: intra-articular injection of Hylan G-F 20 Phase 4

Detailed Description:
Two courses of Hylan G-F 20 ( Synvisc) administered by intra-articular injection at 6 monthly intervals. MRI examinations of the knee for estimation of cartilage volume prior to treatment, before second course and at 12 months in 40 subjects with Grade 2/3 osteoarthritis of knee . A further 40 subjects with similar degree of osteoarthritis of knee who do not receive Hylan G-F therapy will be assessed by MRI in identical manner.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Single-Blind Prospective Parallel Control Group Pilot Study to Assess the Effect of Hylan G-F 20 (Synvisc) Supplementation on Cartilage Preservation in Osteoarthritis of the Knee
Study Start Date : January 2006
Estimated Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Cartilage volume as assessed by magnetic resonance imaging

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • grade 2 or 3 osteoarthritis knee age 18 - 80 pain score VAS >39 mm on 100mm scale

Exclusion Criteria:

  • surgery in prior 12 months significant valgus deformity recent trauma use of opioid analgesia unstable medical condition recent corticosteroid injection morbid obesity
Contacts and Locations

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): NCT00393393


Contacts
Contact: stephen hall, MBBS, FRACP 613 9509 6166 drshall@ozemail.com.au
Contact: marie feletar, MBBS, FRACP 613 9509 6166 mfeletar@westnet.com.au

Locations
Australia, Victoria
Emeritus Research Recruiting
Malvern, Victoria, Australia, 3144
Principal Investigator: stephen hall, MBBS, FRACP         
Sponsors and Collaborators
Cabrini Medical Centre
Genzyme, a Sanofi Company
Investigators
Principal Investigator: stephen hall, MBBS, FRACP Cabrini Medical Centre
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00393393     History of Changes
Other Study ID Numbers: 05-11-07-05
First Posted: October 27, 2006    Key Record Dates
Last Update Posted: October 27, 2006
Last Verified: October 2006

Keywords provided by Cabrini Medical Centre:
osteoarthritis
knee
hylan

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hylan
Hyaluronic Acid
Viscosupplements
Protective Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors