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

Primary Purpose

Osteoarthritis

Status

Unknown status

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

intra-articular injection of Hylan G-F 20

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, knee, hylan

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emeritus ResearchRecruiting

Outcomes

Primary Outcome Measures

Cartilage volume as assessed by magnetic resonance imaging

Secondary Outcome Measures

Full Information

NCT ID

NCT00393393

First Posted

October 26, 2006

Last Updated

October 26, 2006

Sponsor

Cabrini Medical Centre

Collaborators

Genzyme, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00393393

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Unknown status

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Cabrini Medical Centre

Collaborators

Genzyme, a Sanofi Company

4. Oversight

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

osteoarthritis, knee, hylan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Non-Randomized

Enrollment

80 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

intra-articular injection of Hylan G-F 20

Primary Outcome Measure Information:

Title

Cartilage volume as assessed by magnetic resonance imaging

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

stephen hall, MBBS, FRACP

Phone

613 9509 6166

drshall@ozemail.com.au

First Name & Middle Initial & Last Name or Official Title & Degree

marie feletar, MBBS, FRACP

Phone

613 9509 6166

mfeletar@westnet.com.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

stephen hall, MBBS, FRACP

Organizational Affiliation

Cabrini Medical Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emeritus Research

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

stephen hall, MBBS, FRACP

12. IPD Sharing Statement

Citations:

PubMed Identifier

21861935

Citation

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.

Results Reference

derived

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

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