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Trial registered on ANZCTR


Registration number
ACTRN12613000882729
Ethics application status
Approved
Date submitted
2/08/2013
Date registered
7/08/2013
Date last updated
19/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is a new type of socket joint of a hip prosthesis stable without the use of screws in patients undergoing total hip replacement?
Scientific title
Radiostereometric analysis of acetabular component migration following randomisation to either a non-holed tantalum trabecular metal-coated acetabular shell or a cluster-holed titanium fibre metal-coated acetabular shell fixed with one or two screws in patients with osteoarthritis scheduled to undergo primary total hip replacement through posterior a approach
Secondary ID [1] 282939 0
None
Universal Trial Number (UTN)
U1111-1146-3066
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migration of the acetabular component of a total hip replacement prosthesis 289758 0
Condition category
Condition code
Musculoskeletal 290099 290099 0 0
Osteoarthritis
Surgery 290126 290126 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary total hip replacement using a tantalum trabecular metal coated acetabular shell. This is a surgical procedure where the femoral head is removed and replaced by a 28 mm metal prosthetic femoral head, 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. Initial stability of the shell is achieved by press-fit fixation, without the use of screws. 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 periprosthetic bone to enable determination of acetabular component migration using a highly sophisticated radiographic technique, namely radiostereometric analysis.
Intervention code [1] 287643 0
Treatment: Devices
Intervention code [2] 287661 0
Treatment: Surgery
Comparator / control treatment
Primary total hip replacement using a titanium fibre metal coated acetabular shell. This is a surgical procedure where the femoral head is removed and replaced by a 28 mm metal prosthetic femoral head, 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. Initial stability of the shell is achieved through the use of one or two screws 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.
Control group
Active

Outcomes
Primary outcome [1] 290140 0
Percentage of patients with acetabular shell migration exceeding 1 mm, as measured by radiostereometric analysis.
Timepoint [1] 290140 0
2 years following total hip replacement
Secondary outcome [1] 304007 0
Mean acetabular component migration, as measured by radiostereometric analysis
Timepoint [1] 304007 0
1, 2, 3, 5, 7 and 10 years following total hip replacement

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
Minimum age
40 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. previous infection
2. inflammatory arthritis
3. Crowe-2 DDH or worse dysplasia
4. abnormal acetabulum
5. increased risk of osteopaenia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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 either to a tantalum trabecular metal or titanium fibre metal acetabular component is opened intra-operatively and, after intra-operative exclusion criteria have been assessed, the allocated acetabular component is inserted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients are stratified for a number of factors that may affect outcomes (eg surgeon, age).
A listing of all possible combinations of allocations in pre-determined block sizes was prepared 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.
Blocked randomisation is then undertaken within strata, with patients being randomised to receive a total hip prosthesis with either a tantalum trabecular metal or titanium fibre metal acetabular component.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size has been calculated on the basis of determining migration of the acetabular component from 0 to 2 years, using Makuch and Simon's method to show equivalence between groups. Specifically, a total sample size of 54 has been calculated as being necessary to show with 80% probability (1 - beta) that the two-sided 90% confidence limit (alpha) for the true difference in migration between the trabecular metal and titanium fibre groups does not exceed 0.20 (difference), assuming that 75% (p) of acetabular components will not migrate more than 1 mm at two years.
The sample size is increased to 64 to allow for attrition due to death and loss to follow-up.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1388 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7249 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 287729 0
Government body
Name [1] 287729 0
National Health and Medical Research Council
Address [1] 287729 0
Level 1,
16 Marcus Clarke St,
Canberra ACT 2601
Country [1] 287729 0
Australia
Primary sponsor type
Individual
Name
Prof Donald Howie
Address
Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 286457 0
Individual
Name [1] 286457 0
Dr Oksana Holubowycz
Address [1] 286457 0
Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country [1] 286457 0
Australia
Other collaborator category [1] 277563 0
Individual
Name [1] 277563 0
Assoc Prof LB Solomon
Address [1] 277563 0
Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country [1] 277563 0
Australia
Other collaborator category [2] 277564 0
Individual
Name [2] 277564 0
Mr Stuart Callary
Address [2] 277564 0
Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country [2] 277564 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289685 0
Royal Adelaide Hospital Research Ethics committee
Ethics committee address [1] 289685 0
Level 3, Hanson Institute
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Ethics committee country [1] 289685 0
Australia
Date submitted for ethics approval [1] 289685 0
Approval date [1] 289685 0
31/01/2007
Ethics approval number [1] 289685 0
031114c

Summary
Brief summary
This randomised controlled trial aims to determine whether a tantalum trabecular metal acetabular component in a primary total hip replacement prosthesis can achieve adequate initial fixation without the use of screws. This study utilises radiostereometric analysis, the most sensitive radiographic technique available to measure acetabular component migration in vivo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41886 0
Prof Donald Howie
Address 41886 0
Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 41886 0
Australia
Phone 41886 0
+61 8 8222 5563
Fax 41886 0
Email 41886 0
donald.howie@health.sa.gov.au
Contact person for public queries
Name 41887 0
Dr Oksana Holubowycz
Address 41887 0
Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 41887 0
Australia
Phone 41887 0
+61 8 8222 5760
Fax 41887 0
Email 41887 0
oksana.holubowycz@health.sa.gov.au
Contact person for scientific queries
Name 41888 0
Dr Oksana Holubowycz
Address 41888 0
Department of Orthopaedics and Trauma
Level 4, Bice Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 41888 0
Australia
Phone 41888 0
+61 8 8222 5760
Fax 41888 0
Email 41888 0
oksana.holubowycz@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary