Effectiveness Study of Hylan G-F 20 to Preserve Cartilage... | NCT00393393

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

NCT00393393

Sponsor

Cabrini Medical Centre

Status

Unknown status

Last Update Posted

Oct 27, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Osteoarthritis

Interventions

intra-articular injection of Hylan G-F 20

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Oct 26, 2006

First Submission Date that Met QC Criteria

Oct 26, 2006

First Posted Date

Oct 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2006

Last Update Posted Date

Oct 27, 2006Estimated

Name	Class
Genzyme, a Sanofi Company	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
intra-articular injection of Hylan G-F 20	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cartilage volume as assessed by magnetic resonance imaging

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
stephen hall, MBBS, FRACP	Contact	613 9509 6166		drshall@ozemail.com.au
marie feletar, MBBS, FRACP	Contact	613 9509 6166		mfeletar@westnet.com.au

Overall Officials

Name	Affiliation	Role
stephen hall, MBBS, FRACP	Cabrini Medical Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emeritus Research	Recruiting	Malvern	Victoria	3144	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21861935	Derived	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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases