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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00393393




Registration number
NCT00393393
Ethics application status
Date submitted
26/10/2006
Date registered
27/10/2006
Date last updated
27/10/2006

Titles & IDs
Public title
Effectiveness Study of Hylan G-F 20 to Preserve Cartilage in Osteoarthritis of the Knee
Scientific 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
Secondary ID [1] 0 0
05-11-07-05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - intra-articular injection of Hylan G-F 20

Treatment: Drugs: intra-articular injection of Hylan G-F 20
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cartilage volume as assessed by magnetic resonance imaging
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- grade 2 or 3 osteoarthritis knee age 18 - 80 pain score VAS >39 mm on 100mm scale
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- surgery in prior 12 months significant valgus deformity recent trauma use of opioid
analgesia unstable medical condition recent corticosteroid injection morbid obesity

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Emeritus Research - Malvern
Recruitment postcode(s) [1] 0 0
3144 - Malvern

Funding & Sponsors
Primary sponsor type
Other
Name
Cabrini Medical Centre
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Genzyme, a Sanofi Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00393393
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
stephen hall, MBBS, FRACP
Address 0 0
Cabrini Medical Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
stephen hall, MBBS, FRACP
Address 0 0
Country 0 0
Phone 0 0
613 9509 6166
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00393393