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Trial registered on ANZCTR
Registration number
ACTRN12613000860763
Ethics application status
Approved
Date submitted
31/07/2013
Date registered
5/08/2013
Date last updated
7/08/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Does the use of a larger femoral head in total hip replacement increase the amount of wear of the plastic liner or the amount of movement of the acetabular cup?
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Scientific title
Radiostereometric analysis of polyethylene wear and acetabular component migration following randomisation to either a large 36 mm or standard 28 mm diameter metal on highly cross-linked polyethylene articulation in primary total hip replacement
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Secondary ID [1]
282914
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None
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Universal Trial Number (UTN)
U1111-1146-0821
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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:
Polyethylene wear of the highly cross-linked polyethylene liner of the acetabular component of the total hip replacement prosthesis
289727
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Migration of the acetabular component of the total hip replacement prosthesis
289728
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Condition category
Condition code
Musculoskeletal
290056
290056
0
0
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Osteoarthritis
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Surgery
290125
290125
0
0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Primary total hip replacement using a 36 mm metal on highly cross-linked polyethylene articulation. This is a surgical procedure where the femoral head is removed and replaced by a metal prosthetic femoral head (which in this situation has a diameter of 36 mm), which is attached to a femoral stem inserted into the femur. The head then articulates with a plastic (highly cross-linked polyethylene) liner in a metal acetabular shell, which is inserted into the acetabulum. The duration of the operation is between about 45 minutes and 4 hours, depending on the complexity of the operation.
During the operation tiny tantalum beads are inserted into the polyethylene liner and periprosthetic bone to enable determination of polyethylene wear and acetabular component migration using a highly sophisticated radiographic technique, namely radiostereometric analysis.
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Intervention code [1]
287611
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Treatment: Devices
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Intervention code [2]
287660
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Treatment: Surgery
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Comparator / control treatment
Primary total hip replacement using a 28 mm metal on highly cross-linked polyethylene articulation. This is a surgical procedure where the femoral head is removed and replaced by a metal prosthetic femoral head (which in this situation has a diameter of 28 mm), which is attached to a femoral stem inserted into the femur. The head then articulates with a plastic (highly cross-linked polyethylene) liner in a metal acetabular shell, which is inserted into the acetabulum. The duration of the operation is between about 45 minutes and 4 hours, depending on the complexity of the operation.
During the operation tiny tantalum beads are inserted into the polyethylene liner and periprosthetic bone to enable determination of polyethylene wear and acetabular component migration using a highly sophisticated radiographic technique, namely radiostereometric analysis.
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Control group
Active
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Outcomes
Primary outcome [1]
290110
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Mean proximal linear polyethylene wear, as measured by radiostereometric analysis
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Assessment method [1]
290110
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Timepoint [1]
290110
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Between 3 months and 2 years following total hip replacement
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Secondary outcome [1]
303964
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Mean proximal linear wear, as measured by radiostereometric analysis
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Assessment method [1]
303964
0
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Timepoint [1]
303964
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Between 3 months and 3, 5, 7 and 10 years following total hip replacement
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Secondary outcome [2]
303965
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Percentage of patients exceeding 0.14 mm of proximal linear polyethylene wear, as measured by radiostereometric analysis
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Assessment method [2]
303965
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Timepoint [2]
303965
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Between 3 months and 2 years following total hip replacement
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Secondary outcome [3]
303966
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Mean acetabular component migration, as measured by radiostereometric analysis
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Assessment method [3]
303966
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Timepoint [3]
303966
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1, 2, 3, 5, 7 and 10 years following total hip replacement
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Eligibility
Key inclusion criteria
1. undergoing primary total hip replacement through posterior approach
2. diagnosis of osteoarthritis
3. walking ability restricted only by hip pathology
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Minimum age
65
Years
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Maximum age
74
Years
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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. previous infection
2. abnormal acetabulum
3. abnormal abductor mechanism
4. expected leg length inequality >5 cm
5. neuromuscular disease affecting hip
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A Registration Form detailing all inclusion and exclusion criteria is completed for every patient who is to undergo primary total hip replacement by one of the collaborating surgeons. All eligible patients are then given a Patient Information Sheet/Consent Form. Consenting patients are then stratified and randomised. An envelope with the allocation of either a 28 or 36 mm diameter articulation is opened intra-operatively, after intra-operative exclusion criteria have been assessed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A listing of all possible combinations of allocations in blocks of 2 to 8 was prepared (eg for a block of 4: 28,28,36,36; 36,36,28,28, 36,28,36,28 etc) and each combination was allocated a number. Then a random number generator was used to choose the combination sequence for the block sizes required in each stratum.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Patients are stratified for a number of factors that may affect primary and secondary outcomes (eg age, sex).
Blocked randomisation is then undertaken within strata, with patients being randomised to receive a total hip prosthesis with either a 28 mm or 36 mm articulation.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
We have based our sample size calculation for the 36 mm articulation on an expected mean proximal linear wear of 0.08 mm between three months and two years, and a maximum acceptable mean proximal linear wear of no more than 0.14 mm between three months and two years. We have chosen to use a significance level of 5% (1-sided) and a power of 90% to calculate our sample size because of the limited amount of current knowledge of the in vivo wear of highly cross-linked polyethylene, especially in the 36 mm articulation.
For a one-sample t-test of equivalence of means, a sample size of 21 is required in each arm of the trial in order to infer that the mean wear from 3 months to two years is no more than 0.14 mm, assuming that the sample mean wear is 0.08 mm, with a standard deviation of 0.09.
The sample size was increased to 27 per arm to allow for attrition due to death and loss to follow-up.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
10/12/2002
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Date of last participant enrolment
Anticipated
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Actual
22/07/2011
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
56
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
1360
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
7219
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
287694
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Government body
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Name [1]
287694
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National Health and Medical Research Council
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Address [1]
287694
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Level 1,
16 Marcus Clarke St,
Canberra ACT 2601
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Country [1]
287694
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Australia
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Funding source category [2]
287709
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University
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Name [2]
287709
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University of Adelaide
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Address [2]
287709
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University of Adelaide SA 5005
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Country [2]
287709
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Australia
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Primary sponsor type
Individual
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Name
Prof Donald Howie
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Address
Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
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Country
Australia
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Secondary sponsor category [1]
286427
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Individual
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Name [1]
286427
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Dr Oksana Holubowycz
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Address [1]
286427
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Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
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Country [1]
286427
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Australia
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Other collaborator category [1]
277542
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Individual
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Name [1]
277542
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Assoc Prof Solomon
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Address [1]
277542
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Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
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Country [1]
277542
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Australia
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Other collaborator category [2]
277543
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Individual
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Name [2]
277543
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Mr Stuart Callary
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Address [2]
277543
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Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
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Country [2]
277543
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289654
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Royal Adelaide Hospital Research Ethics Committee
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Ethics committee address [1]
289654
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Level 3, Hanson Institute
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
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Ethics committee country [1]
289654
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Australia
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Date submitted for ethics approval [1]
289654
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Approval date [1]
289654
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08/11/2002
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Ethics approval number [1]
289654
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010504c
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Summary
Brief summary
This randomised controlled trial aims to determine whether a primary total hip replacement prosthesis with a larger 36 mm diameter metal on highly cross-linked polyethylene articulation is associated with significantly greater polyethylene wear and acetabular component migration. This study utilises radiostereometric analysis, the most sensitive radiographic technique available to measure wear and migration in vivo.
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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
41794
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Prof Donald Howie
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Address
41794
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Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
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Country
41794
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Australia
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Phone
41794
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+61 8 8222 5563
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Fax
41794
0
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Email
41794
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[email protected]
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Contact person for public queries
Name
41795
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Dr Oksana Holubowycz
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Address
41795
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Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
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Country
41795
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Australia
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Phone
41795
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+61 8 8222 5760
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Fax
41795
0
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Email
41795
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[email protected]
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Contact person for scientific queries
Name
41796
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Dr Oksana Holubowycz
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Address
41796
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Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
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Country
41796
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Australia
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Phone
41796
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+61 8 8222 5760
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Fax
41796
0
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Email
41796
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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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