Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
Metal ion levels at 1 year post primary unilateral Exeter total hip arthroplasty
Secondary ID [1] 282768 0
Nil
Universal Trial Number (UTN)
U1111-1145-1994
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 289516 0
Condition category
Condition code
Musculoskeletal 289841 289841 0 0
Osteoarthritis
Surgery 289934 289934 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
metal ion levels at 1 year post total hip replacement
Intervention code [1] 287438 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289910 0
serum cobalt and chromium levels
Timepoint [1] 289910 0
one year post surgery
Secondary outcome [1] 303533 0
nil
Timepoint [1] 303533 0
nil

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
basic demographics will be presented
results will be descriptive and no formal statistics are required

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2011
Actual
23/02/2012
Date of last participant enrolment
Anticipated
1/11/2012
Actual
2/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1191 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 7054 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 287539 0
Self funded/Unfunded
Name [1] 287539 0
Professor Ross Crawford
Country [1] 287539 0
Australia
Primary sponsor type
Individual
Name
Professor Ross Crawford
Address
Orthopaedic Research Unit
Institute of Health and Biomedical Innovation
The Prince Charles Hospital
Rode Road
Chermside
Queensland
4032
Country
Australia
Secondary sponsor category [1] 286291 0
None
Name [1] 286291 0
none
Address [1] 286291 0
Country [1] 286291 0
Other collaborator category [1] 277511 0
Individual
Name [1] 277511 0
Dr Hugh English
Address [1] 277511 0
Brisbane Orthopaedic Sports Specialists
Holy Spirit Northside Hospital
Rode Road
Chermside
Queensland
4032
Country [1] 277511 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289557 0
the Prince Charles Hospital
Ethics committee address [1] 289557 0
Human Research Ethics Committee
The Prince Charles Hospital
Metro North Health Service District
Administration Building, Lower Ground
Rode Road, Chermside QLD 4032
Ethics committee country [1] 289557 0
Australia
Date submitted for ethics approval [1] 289557 0
Approval date [1] 289557 0
20/09/2011
Ethics approval number [1] 289557 0
HREC/11/QPCH/172

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41158 0
Prof Ross Crawford
Address 41158 0
Orthopaedic Research Unit
Level 5, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
Country 41158 0
Australia
Phone 41158 0
+61 7 3139 4481
Fax 41158 0
Email 41158 0
[email protected]
Contact person for public queries
Name 41159 0
Sarah Whitehouse
Address 41159 0
Orthopaedic Research Unit
Level 5, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
Country 41159 0
Australia
Phone 41159 0
+61 7 3139 6672
Fax 41159 0
Email 41159 0
[email protected]
Contact person for scientific queries
Name 41160 0
Sarah Whitehouse
Address 41160 0
Orthopaedic Research Unit
Level 5, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
Country 41160 0
Australia
Phone 41160 0
+61 7 3139 6672
Fax 41160 0
Email 41160 0
[email protected]

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.