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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Cabrini Medical Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Cabrini Medical Centre
ClinicalTrials.gov Identifier:
NCT00393393
First received: October 26, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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 Intervention Phase
Osteoarthritis
Drug: intra-articular injection of Hylan G-F 20
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Cabrini Medical Centre:

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

Estimated Enrollment: 80
Study Start Date: January 2006
Estimated Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided by Cabrini Medical Centre

Additional 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
Study First Received: October 26, 2006
Last Updated: October 26, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Cabrini Medical Centre:
osteoarthritis
knee
hylan

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 22, 2014