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Trial registered on ANZCTR
Registration number
ACTRN12613000787785
Ethics application status
Approved
Date submitted
10/07/2013
Date registered
15/07/2013
Date last updated
15/07/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Metal ion levels post primary unilateral Exeter total hip arthroplasty
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Scientific title
Metal ion levels at 1 year post primary unilateral Exeter total hip arthroplasty
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Secondary ID [1]
282768
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Nil
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Universal Trial Number (UTN)
U1111-1145-1994
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
osteoarthritis
289516
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Condition category
Condition code
Musculoskeletal
289841
289841
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0
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Osteoarthritis
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Surgery
289934
289934
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0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
metal ion levels at 1 year post total hip replacement
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Intervention code [1]
287438
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Not applicable
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Comparator / control treatment
no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
289910
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serum cobalt and chromium levels
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Assessment method [1]
289910
0
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Timepoint [1]
289910
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one year post surgery
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Secondary outcome [1]
303533
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nil
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Assessment method [1]
303533
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Timepoint [1]
303533
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nil
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Eligibility
Key inclusion criteria
(1) one year post primary unilateral Exeter V40 total hip replacement (cemented femoral component with cemented or uncemented acetabular component),
(2) no prosthesis or metalwork elsewhere,
(3) Harris Hip Score > 80 and no signs/symptoms of infection,
(4) no radiographical signs of loosening,
(5) no significant systemic diseases affecting metal metabolism (including chronic renal failure with eGFR < 30) and
(6) no chronic exposure to metal ions (eg occupational)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(1) more than one joint replaced
(2) harris hip score <=80
(3) signs or symptoms of infection
(4) loosening on x-ray
(5)presence of systemic diseases known to affect metal metabolism
(6) chronic exposure to metal ions
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
basic demographics will be presented
results will be descriptive and no formal statistics are required
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/11/2011
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Actual
23/02/2012
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Date of last participant enrolment
Anticipated
1/11/2012
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Actual
2/08/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
1191
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The Prince Charles Hospital - Chermside
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Recruitment postcode(s) [1]
7054
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4032 - Chermside
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Funding & Sponsors
Funding source category [1]
287539
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Self funded/Unfunded
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Name [1]
287539
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Professor Ross Crawford
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Address [1]
287539
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Orthopaedic Research Unit
Institute of Health and Biomedical Innovation
The Prince Charles Hospital
Rode Road
Chermside
Queensland
4032
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Country [1]
287539
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Australia
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Primary sponsor type
Individual
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Name
Professor Ross Crawford
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Address
Orthopaedic Research Unit
Institute of Health and Biomedical Innovation
The Prince Charles Hospital
Rode Road
Chermside
Queensland
4032
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Country
Australia
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Secondary sponsor category [1]
286291
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None
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Name [1]
286291
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none
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Address [1]
286291
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Country [1]
286291
0
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Other collaborator category [1]
277511
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Individual
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Name [1]
277511
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Dr Hugh English
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Address [1]
277511
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Brisbane Orthopaedic Sports Specialists
Holy Spirit Northside Hospital
Rode Road
Chermside
Queensland
4032
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Country [1]
277511
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289557
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the Prince Charles Hospital
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Ethics committee address [1]
289557
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Human Research Ethics Committee
The Prince Charles Hospital
Metro North Health Service District
Administration Building, Lower Ground
Rode Road, Chermside QLD 4032
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Ethics committee country [1]
289557
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Australia
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Date submitted for ethics approval [1]
289557
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Approval date [1]
289557
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20/09/2011
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Ethics approval number [1]
289557
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HREC/11/QPCH/172
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Summary
Brief summary
Metal ion release is common following total hip arthroplasty, yet postoperative levels have not been defined for most stems currently used in clinical practice.
The Exeter stem is the most commonly used cemented stem in Australia. The aim of this study is to assess metal ion release in the serum of patients with well functioning unilateral Exeter V40 primary total hip arthroplasties one year after surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
41158
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Prof Ross Crawford
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Address
41158
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Orthopaedic Research Unit
Level 5, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
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Country
41158
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Australia
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Phone
41158
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+61 7 3139 4481
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Fax
41158
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Email
41158
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[email protected]
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Contact person for public queries
Name
41159
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Dr Sarah Whitehouse
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Address
41159
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Orthopaedic Research Unit
Level 5, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
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Country
41159
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Australia
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Phone
41159
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+61 7 3139 6672
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Fax
41159
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Email
41159
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[email protected]
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Contact person for scientific queries
Name
41160
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Dr Sarah Whitehouse
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Address
41160
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Orthopaedic Research Unit
Level 5, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
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Country
41160
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Australia
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Phone
41160
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+61 7 3139 6672
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Fax
41160
0
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Email
41160
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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