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Trial registered on ANZCTR


Registration number
ACTRN12609000423213
Ethics application status
Approved
Date submitted
30/05/2009
Date registered
10/06/2009
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial comparing Ceramic-on-Metal and Metal-on-Metal arthroplasty bearing surfaces - functional outcomes and serum metal ion levels following total hip arthroplasty
Scientific title
An evaluation of ceramic-on-metal versus metal-on-metal bearing surface on functional scores, serum metal ion levels and radiological parameters in patients receiving total hip arthoplasty
Secondary ID [1] 283679 0
Nil Known





Universal Trial Number (UTN)
Trial acronym
COMBAT trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis / Total Hip Joint Replacement 4885 0
Condition category
Condition code
Surgery 237237 237237 0 0
Surgical techniques
Musculoskeletal 237293 237293 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both arms of the study involve total hip joint replacement - performed with cementless implants (Pinnacle acetabular shell with Ultramet metal insert with a Corail cementless femoral stem). The patient will then be randomised to receive either a ceramic (biolox) or metal (ultamet) femoral head. Operation time is estimated at 60 minutes.
Intervention code [1] 236672 0
Treatment: Surgery
Comparator / control treatment
Both arms of the study involve total hip joint replacement - performed with cementless implants (Pinnacle acetabular shell with Ultramet metal insert with a Corail cementless femoral stem). The patient will then be randomised to receive either a ceramic (biolox) or metal (ultamet) femoral head. Operation time is estimated at 60 minutes.
Control group
Active

Outcomes
Primary outcome [1] 238053 0
Serum Metal Ion levels - Cobalt and Chromium
Timepoint [1] 238053 0
6,12,24 and 60 months following procedure
Secondary outcome [1] 242240 0
Overall hip joint evaluation measured by University of California at Los Angeles (UCLA) activity score, Harris Hip Score, and Oxford Score
Timepoint [1] 242240 0
6,12,24 and 60 months follwoing procedure

Eligibility
Key inclusion criteria
Patients clinically suitable for a 'hard-on hard' total hip replacement bearing surface
Primary total hip arthroplasty
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contra-lateral hip arthroplasty with a metal-on-metal bearing surface.
Chronic Renal Failure

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)
Allocation involves contacting the holder of the allocation sequence who is 'off-site'
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation sequence has been prepared in advance using computerised sequence generation . The sequence includes a treatment allocation stratified by surgeon.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 1820 0
New Zealand
State/province [1] 1820 0
Canterbury

Funding & Sponsors
Funding source category [1] 5062 0
Charities/Societies/Foundations
Name [1] 5062 0
Wishbone Trust
Address [1] 5062 0
C/- New Zealand Orthopaedic Association (NZOA)
43 Kent Terrace
PO Box 7451
Wellington
Country [1] 5062 0
New Zealand
Primary sponsor type
Individual
Name
Rowan Schouten
Address
Orthopaedic Department
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch
Country
New Zealand
Secondary sponsor category [1] 4571 0
None
Name [1] 4571 0
Address [1] 4571 0
Country [1] 4571 0
Other collaborator category [1] 694 0
Individual
Name [1] 694 0
Associate Professor Gary Hooper
Address [1] 694 0
Orthopaedic Department
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch
Country [1] 694 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239165 0
Upper South A Ethics Committee
Ethics committee address [1] 239165 0
Courier address:
C/- Ministry of Health
4th floor
250 Oxford St
Christchurch
Ethics committee country [1] 239165 0
New Zealand
Date submitted for ethics approval [1] 239165 0
Approval date [1] 239165 0
10/02/2009
Ethics approval number [1] 239165 0
URA/09/01/001

Summary
Brief summary
This randomised controlled study of 80 patients receiving total hip joint replacements aims to compare the post operative serum metal ion levels, functional outcomes and radiological parameters of ceramic-on-metal and metal-on-metal bearing surfaces. All patients will receive the same acetabular component (Pinnacle) and femoral stem (Corail) with only the femoral head component been randomised to either a biolox cermic head of ultamet metal head. Results at 6,12,24 and 60 months will be compared.
Trial website
Trial related presentations / publications
A prospective, randomised controlled trial comparing ceramic-on-metal and metal-on-metal bearing surfaces in total hip arthroplasty. JBJS(B) Nov 2012, 1462-1469.
Public notes

Contacts
Principal investigator
Name 29671 0
Mr Rowan Schouten
Address 29671 0
Orthopaedic Department
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch
Country 29671 0
New Zealand
Phone 29671 0
+ 64 21 522 757
Fax 29671 0
Email 29671 0
rowanschouten@gmail.com
Contact person for public queries
Name 12918 0
Mr Rowan Schouten
Address 12918 0
Orthopaedic Department
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch
Country 12918 0
New Zealand
Phone 12918 0
+64 21 522 757
Fax 12918 0
Email 12918 0
rowanschouten@gmail.com
Contact person for scientific queries
Name 3846 0
Mr Rowan Schouten
Address 3846 0
Orthopaedic Department
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch
Country 3846 0
New Zealand
Phone 3846 0
+64 21 522 757
Fax 3846 0
Email 3846 0
rowanschouten@gmail.com

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