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

This study is currently recruiting participants.

Verified by Cabrini Medical Centre, October 2006

First Received: October 26, 2006 No Changes Posted

Sponsors and Collaborators:	Cabrini Medical Centre Genzyme
Information provided by:	Cabrini Medical Centre
ClinicalTrials.gov Identifier:	NCT00393393

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 IV

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Uncontrolled, Parallel Assignment, Efficacy Study
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

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

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

Investigators

Principal Investigator:

stephen hall, MBBS, FRACP

Cabrini Medical Centre

More Information

No publications provided

Study ID Numbers:	05-11-07-05
Study First Received:	October 26, 2006
Last Updated:	October 26, 2006
ClinicalTrials.gov Identifier:	NCT00393393 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Cabrini Medical Centre:

osteoarthritis
knee
hylan

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009