Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000877583
Ethics application status
Submitted, not yet approved
Date submitted
3/08/2015
Date registered
21/08/2015
Date last updated
26/07/2016
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
Nil
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
Osteoarthritis

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent
Unable to participate travel for radiological assessment
Deceased

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 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Withdrawn
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
Anticipated
1/09/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
61
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
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
Country [1] 291767 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Joint Studio
Address
1/ 85 Monash Ave, Nedlands WA 6019
Country
Australia
Secondary sponsor category [1] 290435 0
Hospital
Name [1] 290435 0
Hollywood Private Hospital
Address [1] 290435 0
Monash Ave, Nedlands WA 6009
Country [1] 290435 0
Australia

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
Australia
Date submitted for ethics approval [1] 293286 0
30/04/2015
Approval date [1] 293286 0
10/07/2015
Ethics approval number [1] 293286 0
HPH417

Summary
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

Contacts
Principal investigator
Name 59258 0
Dr Dan Fick
Address 59258 0
The Joint Studio
1/ 85 Monash Ave, Nedlands WA 6009
Country 59258 0
Australia
Phone 59258 0
+61 8 93863933
Fax 59258 0
Email 59258 0
[email protected]
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
Australia
Phone 59259 0
+61 8 93863933
Fax 59259 0
Email 59259 0
[email protected]
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
Australia
Phone 59260 0
+61 8 93863933
Fax 59260 0
Email 59260 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.