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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00850538




Registration number
NCT00850538
Ethics application status
Date submitted
23/02/2009
Date registered
25/02/2009
Date last updated
4/12/2015

Titles & IDs
Public title
Role of Bone in Knee Osteoarthritis (OA)
Scientific title
The Role of Bone and Its Measurement in Knee Osteoarthritis
Secondary ID [1] 0 0
NEBH 2008-018
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - MRI
Treatment: Surgery - Primary Total Knee Replacement

Treatment: Other: MRI
1.5T MRI exam of signal knee with knee coil (estimated time: 35 minutes)

Treatment: Surgery: Primary Total Knee Replacement
Fluid, bone, and meniscus specimens obtained from total joint replacement will be collected.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Viable Specimens for Genetic Analysis
Timepoint [1] 0 0
Tissue samples collected at time of surgery

Eligibility
Key inclusion criteria
* subjects having primary knee replacement surgery with 1 participating surgeon at NEBH (principal investigator)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* subjects having a revision knee replacement instead of a primary knee replacement
* contraindications for MRI
* pregnancy

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
02120 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The New England Baptist Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Hunter, MD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00850538