NCT00393393

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2006

Completed
Last Updated

October 27, 2006

Status Verified

October 1, 2006

First QC Date

October 26, 2006

Last Update Submit

October 26, 2006

Conditions

Osteoarthritis

Keywords

osteoarthritiskneehylan

Outcome Measures

Primary Outcomes (1)

  • Cartilage volume as assessed by magnetic resonance imaging

Interventions

intra-articular injection of Hylan G-F 20DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • grade 2 or 3 osteoarthritis knee age 18 - 80 pain score VAS \>39 mm on 100mm scale

You may not qualify if:

  • surgery in prior 12 months significant valgus deformity recent trauma use of opioid analgesia unstable medical condition recent corticosteroid injection morbid obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emeritus Research

Malvern, Victoria, 3144, Australia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21861935DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • stephen hall, MBBS, FRACP

    Cabrini Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

stephen hall, MBBS, FRACP

CONTACT

613 9509 6166drshall@ozemail.com.au

marie feletar, MBBS, FRACP

CONTACT

613 9509 6166mfeletar@westnet.com.au

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 27, 2006

Study Start

January 1, 2006

Study Completion

January 1, 2006

Last Updated

October 27, 2006

Record last verified: 2006-10

Locations

AU(1)