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Trial registered on ANZCTR

Registration number
Ethics application status
Submitted, not yet approved
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
In Total Hip Replacement, do ceramic-ceramic or highly-cross-linked plastic bearing surfaces have less migration and wear at 12 years?
Scientific title
In Total Hip Replacement, do ceramic-ceramic or highly-cross-linked plastic bearing surfaces have less migration and wear at 12 years?
Secondary ID [1] 287200 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Replacement 295788 0
Condition category
Condition code
Surgery 296058 296058 0 0
Surgical techniques
Musculoskeletal 296189 296189 0 0

Study type
Description of intervention(s) / exposure
The Reflection 1 or 5 cup (Smith and Nephew) with a porous coating and a cemented Spectron stem (Smith and Nephew) were used in a previous trial. Ceramic-ceramic group received a liner and head of aluminium oxide ceramic. Zhou Z-K, Li MG, Borlin N, Wood DJ, Nivbrant B. No increased migration in cups with ceramic-on-ceramic bearing: An RSA study. Clin Orthop Relat Res. 2006; 448: 39-45.
Intervention code [1] 292484 0
Treatment: Surgery
Comparator / control treatment
Acetabular highly cross-linked plastic bearing. This group received a metal (cobalt chromium) head and a highly cross-linked plastic liner.
Control group

Primary outcome [1] 295729 0
Wear rates via RSA migration
Timepoint [1] 295729 0
12 years post-surgery
Primary outcome [2] 295796 0
Revision rates (collated from patient enquiry and review of medical records)
Timepoint [2] 295796 0
12 years post-surgery
Secondary outcome [1] 316346 0
Hip joint function (Harris Hip Score, WOMAC Hip score)
Timepoint [1] 316346 0
12 years post-surgery

Key inclusion criteria
Follow-up study. Invite to participants of a previous RCT. This study had inclusion of primary total hip replacement for osteoarthritis. Participants were recruited from the waitlist of 2 senior orthopaedic surgeons.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Unable to provide informed consent
Unable to participate travel for radiological assessment

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Due to the high precision of RSA, excessively migrating prostheses can be discriminated, and failure predicted, using only a small sample size: about 15–25 patients (Valstar et al. 2005)

Recruitment status
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
study terminated, ethics approved one site pending approval at another which was not approved
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 4125 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [2] 4126 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 10052 0
6009 - Broadway Nedlands

Funding & Sponsors
Funding source category [1] 291767 0
Other Collaborative groups
Name [1] 291767 0
The Joint Studio
Address [1] 291767 0
Hollywood Medical Centre
1/ 85 Monash Ave, Nedlands WA 6009
Country [1] 291767 0
Primary sponsor type
Other Collaborative groups
The Joint Studio
1/ 85 Monash Ave, Nedlands WA 6019
Secondary sponsor category [1] 290435 0
Name [1] 290435 0
Hollywood Private Hospital
Address [1] 290435 0
Monash Ave, Nedlands WA 6009
Country [1] 290435 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293286 0
Hollywood Private Hospital ethics committee
Ethics committee address [1] 293286 0
Hollywood Private Hospital, Monash Ave, Nedlands
Ethics committee country [1] 293286 0
Date submitted for ethics approval [1] 293286 0
Approval date [1] 293286 0
Ethics approval number [1] 293286 0

Brief summary
We propose to follow up 61 participants from a previous randomized controlled trial conducted in 2001-2002 at SCGH and Hollywood Private Hospital, which randomized participants for total hip replacement to either a ceramic-ceramic or metal-highly-crosslinked-plastic bearing surface. The 12-year outcomes, in terms of radiographically measured wear rate and implant migration, and clinical findings will be determined and presented for each group.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 59258 0
Dr Dan Fick
Address 59258 0
The Joint Studio
1/ 85 Monash Ave, Nedlands WA 6009
Country 59258 0
Phone 59258 0
+61 8 93863933
Fax 59258 0
Email 59258 0
Contact person for public queries
Name 59259 0
Ms Samantha Haebich
Address 59259 0
The Joint Studio
1/ 85 Monash Ave, Nedlands WA 6009
Country 59259 0
Phone 59259 0
+61 8 93863933
Fax 59259 0
Email 59259 0
Contact person for scientific queries
Name 59260 0
Ms Samantha Haebich
Address 59260 0
The Joint Studio
1/ 85 Monash Ave, Nedlands WA 6009
Country 59260 0
Phone 59260 0
+61 8 93863933
Fax 59260 0
Email 59260 0

No information has been provided regarding IPD availability
Summary results
No Results