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

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: 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:
Genzyme, a Sanofi Company
Information provided by:
Cabrini Medical Centre

Tracking Information
First Submitted Date  ICMJE October 26, 2006
First Posted Date  ICMJE October 27, 2006
Last Update Posted Date October 27, 2006
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2006)
Cartilage volume as assessed by magnetic resonance imaging
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness Study of Hylan G-F 20 to Preserve Cartilage in Osteoarthritis of the Knee
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Drug: intra-articular injection of Hylan G-F 20
Study Arms  ICMJE Not Provided
Publications * Wang Y, Hall S, Hanna F, Wluka AE, Grant G, Marks P, Feletar M, Cicuttini FM. Effects of Hylan G-F 20 supplementation on cartilage preservation detected by magnetic resonance imaging in osteoarthritis of the knee: a two-year single-blind clinical trial. BMC Musculoskelet Disord. 2011 Aug 24;12:195. doi: 10.1186/1471-2474-12-195.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: October 26, 2006)
80
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00393393
Other Study ID Numbers  ICMJE 05-11-07-05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Cabrini Medical Centre
Collaborators  ICMJE Genzyme, a Sanofi Company
Investigators  ICMJE
Principal Investigator: stephen hall, MBBS, FRACP Cabrini Medical Centre
PRS Account Cabrini Medical Centre
Verification Date October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP