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

NCT ID: NCT00393393

Last Updated: 2006-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Keywords

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osteoarthritis knee hylan

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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intra-articular injection of Hylan G-F 20

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Cabrini Medical Centre

OTHER

Sponsor Role lead

Principal Investigators

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stephen hall, MBBS, FRACP

Role: PRINCIPAL_INVESTIGATOR

Cabrini Medical Centre

Locations

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Emeritus Research

Malvern, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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stephen hall, MBBS, FRACP

Role: CONTACT

Phone: 613 9509 6166

Email: [email protected]

marie feletar, MBBS, FRACP

Role: CONTACT

Phone: 613 9509 6166

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 21861935 (View on PubMed)

Other Identifiers

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05-11-07-05

Identifier Type: -

Identifier Source: org_study_id