Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000959774
Ethics application status
Approved
Date submitted
12/08/2013
Date registered
29/08/2013
Date last updated
13/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
In-hospital mortality rates after a cemented femoral component for displaced neck of femur fractures.
Scientific title
A prospective cohort study to investigate in-hospital mortality rates after a cemented femoral component for displaced neck of femur fractures.
Secondary ID [1] 283008 0
none
Universal Trial Number (UTN)
U1111-1146-6303
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
displaced fractured neck of femur 289835 0
Condition category
Condition code
Musculoskeletal 290191 290191 0 0
Other muscular and skeletal disorders
Surgery 290192 290192 0 0
Other surgery
Injuries and Accidents 290306 290306 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Fixation with a cemented Exeter femoral component. Currently there is much debate in the orthopaedic community about the standard treatment of these types of fractures and whether the use of cement influences mortality rates. At our institution, all of these fractures are treated with a cemented Exeter femoral component as standard, based on current evidence. However, in order to ensure that this has not resulted in an increase in mortality rate, in-hospital mortality rates were observed to ensure they are within safe limits. Data collected from the period April 2010 (when the Hip Fracture Unit was opened) - July 2012
Intervention code [1] 287722 0
Not applicable
Comparator / control treatment
no comparator - cohort study only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290219 0
In-hospital mortality rates assessed via hospital records and orthopaedic audit database. As we are interested in in-hospital mortality, assessment of records within the episode relating to the surgery were examined (including rehab centre if applicable), until discharge home or to a care facility.
Timepoint [1] 290219 0
in hospital (including rehab facility) relating to the surgical episode for fracture management
Secondary outcome [1] 304141 0
none
Timepoint [1] 304141 0
none

Eligibility
Key inclusion criteria
all patients presenting with a displaced fractured neck of femur where arthroplasty was indicated
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
fixation by methods other than arthroplasty such as pin and plate or hip scews

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
comparison of mortality rates with current published literature. presentation of rates and general demographics

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2010
Actual
10/04/2010
Date of last participant enrolment
Anticipated
Actual
31/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1436 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 7269 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 287773 0
Self funded/Unfunded
Name [1] 287773 0
Country [1] 287773 0
Primary sponsor type
Individual
Name
Professor Ross Crawford
Address
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
Country
Australia
Secondary sponsor category [1] 286500 0
None
Name [1] 286500 0
Address [1] 286500 0
Country [1] 286500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289723 0
The Prince Charles Hospital
Ethics committee address [1] 289723 0
Rode Road
Chermside
Queensland
4032
Ethics committee country [1] 289723 0
Australia
Date submitted for ethics approval [1] 289723 0
Approval date [1] 289723 0
15/04/2013
Ethics approval number [1] 289723 0
HREC/12/QPCH/300

Summary
Brief summary
This cohort study aims to investigate the in-hospital mortality of patients with a displaced femoral neck fracture when treated with a cemented femoral component. This un-selected series will be the largest in the current literature. There is some discussion in the orthopaedic community about the role of cement in post-operative mortality. The aim of this study is to examine this more closely in a controlled setting where every patient requiring arthroplasty receives the same cemented prosthesis as standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42118 0
Prof Ross Crawford
Address 42118 0
Orthopaedic Research Unit
The Prince Charles Hospital
Rode Road
Chermside
Queensland
4032
Country 42118 0
Australia
Phone 42118 0
+61 7 3139 4481
Fax 42118 0
Email 42118 0
[email protected]
Contact person for public queries
Name 42119 0
Dr Sarah Whitehouse
Address 42119 0
Orthopaedic Research Unit
The Prince Charles Hospital
Rode Road
Chermside
Queensland
4032
Country 42119 0
Australia
Phone 42119 0
+61 7 3139 6672
Fax 42119 0
Email 42119 0
[email protected]
Contact person for scientific queries
Name 42120 0
Dr Sarah Whitehouse
Address 42120 0
Orthopaedic Research Unit
The Prince Charles Hospital
Rode Road
Chermside
Queensland
4032
Country 42120 0
Australia
Phone 42120 0
+61 7 3139 6672
Fax 42120 0
Email 42120 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.