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Trial registered on ANZCTR


Registration number
ACTRN12616000952448
Ethics application status
Approved
Date submitted
10/07/2016
Date registered
19/07/2016
Date last updated
3/12/2019
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Wear assessment of highly crossed linked (X3) acetabular liners by Radio stereometric analysis (RSA). An analysis of patients with osteoarthritis treatment hip replacement surgery.
Scientific title
Wear assessment of highly cross-linked (X3) polyethylene liners with Radio stereometric analysis (RSA). A double cohort study of osteoarthritis patients with hip replacements of 32 mm head size compared to 36 to 40mm head sizes.

Secondary ID [1] 289646 0
none
Universal Trial Number (UTN)
U1111-1185-2074
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 299442 0
Condition category
Condition code
Surgery 299423 299423 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with advanced osteoarthritis will be treated with a hip replacement that is the standard practice of the senior author. The migration of femoral head into the polyethylene liner over time will be measured by Radio stereometric analysis (RSA).

The Trident acetabular system comprises a metallic hemispherical acetabular shell, used in association with a highly cross-linked polyethylene liner (X3).. The surgery is performed by a specialist hip arthroplasty surgeon, through a posterior approach and according to normal standards at the clinic.

During surgery six one-mm tantalum markers are inserted in the plastic liner to facilitate migration measurements. This will add about 5 minutes to the 60 minute surgical procedure. Tantalum is the most biocompatible metal known. In 25 years of use no problems have ever been identified with the use of this technique.

Outcomes will be measured by radiological examination and general outcome survey. The general outcome surveys will be compled at the standard follow up visits. These surveys will include the Harris hip a disease specific survey form and SF12 a general outcome survey. The forms will take approximately 20mins to fill out and the patients will be deidentified to protect their privacy

The study is an interventional trial of two groups of patients. The first study cohort will include patients implanted with a standard sized 32 mm femoral head articulating with an X3 polyethylene liner. The first group of patients will have a preliminary analysis to ensure safety and efficacy of the X3 polyethylene. Once initial safety requirements have been met a second group of patients will be recruited with the largest femoral head size that permits a minimum 6mm polyethylene thickness, a 36-40 mm Cobalt Chrome (CoCr) femoral head articulating with a highly cross linked (X3) polyethylene liner.
Intervention code [1] 295263 0
Treatment: Devices
Intervention code [2] 295272 0
Treatment: Surgery
Intervention code [3] 295273 0
Early detection / Screening
Comparator / control treatment
The study consists of two cohorts and both are compared to historical clinical and migration values. There are limited RSA wear studies on conventional and cross-linked polyethylene. Nivbradt et al (Rohl, Nivbrandt, Minuggo, Hewitt, In Vivo Wear and Migration of Highly Cross-linked Polyethylene cups. J Arthroplasty, vol 20 (2), 2005) report RSA derived wear rates for traditional and second-generation cross-linked polyethylene. Campbell et al (Campbell D, et al., Eur J Orthop Surg Traumatol. 2009; 20(1):23-27) report RSA derived wear of an intermediate cross-linked (5Gy) polyethylene and these two studies form an historical control group .
Control group
Historical

Outcomes
Primary outcome [1] 298891 0
RSA assessed femoral head migration as a measure of polyethylene wear.
Timepoint [1] 298891 0
Two years, five years, and 10 years post surgery.
Secondary outcome [1] 325553 0
Oxford hip scores
Timepoint [1] 325553 0
One year and five years post surgery
Secondary outcome [2] 325575 0
SF-12 scores
Timepoint [2] 325575 0
One and five years post surgery
Secondary outcome [3] 325576 0
Harris hip scores.
Timepoint [3] 325576 0
One and five years post surgery

Eligibility
Key inclusion criteria
Patients between 50 and 80 years of age, planned for Total Hip Arthroplasty (THA) due to osteoarthritis
Minimum age
50 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residence outside Adelaide metropolitan area, abnormal gross anatomy of hip, age above 80 years, inflammatory arthritis or severe osteoporosis

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



Intervention assignment
Other
Other design features
Consecutive cohort interventional trial
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Migration and wear is calculated with UMRSA software (RSA Biomedical). Statistic analyses of the material will be done with the SPSS 10 package. Migration and wear differences between patients analyzed with Mann Whitney U-test and repeated measurement ANOVA and correlations to other parameters with linear regression. Probability values of less than 0.05 will be considered significant. An earlier study of the same cup showed a SD of 0.17 mm. Difference in migration between the patients is anticipated to be at least 0.15 mm. To accommodate these facts a power analyses suggests a sample size of 27 patients when comparing two implant types. Again, this number is based on a head-to-head assessment of two different prostheses and is included to indicate our appreciation of what is actually required to meet statistical validity. We believe that the numbers cited (20) with be more than adequate to evaluate the performance of a single system.

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 in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 13585 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 294027 0
Commercial sector/Industry
Name [1] 294027 0
Styrker Australia
Address [1] 294027 0
Stryker South Pacific
PO Box 970
Artarmon NSW 1570
Country [1] 294027 0
Australia
Primary sponsor type
Individual
Name
David Campbell
Address
Wakefield Orthopaedic clinic
270 Wakefield Street
Adelaide5000
Country
Australia
Secondary sponsor category [1] 292849 0
None
Name [1] 292849 0
Address [1] 292849 0
Country [1] 292849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295437 0
Calvary Wakefield research and ethics committee
Ethics committee address [1] 295437 0
Calvary wakeful Street Hospital
250 Wakefield Street
Adelaide 5000
South Australia
Ethics committee country [1] 295437 0
Australia
Date submitted for ethics approval [1] 295437 0
09/06/2004
Approval date [1] 295437 0
21/03/2005
Ethics approval number [1] 295437 0
REC ref: 2007 P1

Summary
Brief summary
Aseptic loosening, wear and dislocation are complications of primary total hip arthroplasty that have a high cost to society and is unpleasant for the patient to endure.

New technology has enabled manufactures to improve the mechanical strength of the bearing surfaces which function well in vitro. Cross-linked polyethylene a second generation polyethylene was introduced into orthopaedic implant designs to address the problems of osteolysis, which is induced by polyethylene wear particles. These implant designs also enable the constructs to accommodate larger femoral heads which create stability and low wear rates which will decrease the amount of osteolysis (Burroughs, Hallstrom et al. 2005) and (Geller, Malchau et al. 2006).

X3 'Trademark' represents the third generation of polyethylene, and has been developed in order to address the issues of reduced mechanical properties compared with second generation cross-linked polyethylene, whilst still maintaining the benefits of reduced wear rates. Hip simulator testing shows that the wear rate of X3 polyethylene is significantly less than conventional cross-linked polyethylene (McKellop, Shen et al. 2000). This reduction in wear will result in significantly less wear particles around the joint and therefore less biological reaction, less osteolysis and a lower incidence of osteolysis induced component failure.

This Radiostereometry analysis (RSA) study will investigate in vivo wear, migration and performance and the results will be compared to the current standard PE liners study using RSA as the form of analysis (Rohrl, Nivbrant et al. 2005).



Hypothesis to be tested

Part 1: Annual volumetric wear of the of the highly cross-linked polyethylene (X3 PE) lining used with a 32mm CoCr head is no more than 0.01mm/annum.

Part 2: Annual volumetric wear of the of the highly cross-linked polyethylene (X3 PE) lining used with a large (36-40mm) CoCr heads is no more than 0.01mm/annum.

Part 3: Annual volumetric wear of the of the highly cross-linked polyethylene (X3 PE) lining used with a Large (36-40mm) CoCr head and thin X3 PE is no more than 0.01mm/annum.
Trial website
Trial related presentations / publications
Second-generation Highly Cross-linked X3 ' Trademark' Polyethylene Wear: A Preliminary Radiostereometric Analysis Study
David G. Campbell, John R. Field and Stuart A. Callary
Clinical Orthopaedics and Related Research. 468 910), 2704-2709 , 2010
DOI: 10.1007/s11999-010-1259-y

Low Wear of a Second-generation Highly Cross-linked Polyethylene Liner:
A 5-year Radiostereometric Analysis Study
Stuart A. Callary, John R. Field, David G. Campbell
Clinical Orthopaedics and Related Research. 2013
Nov;471(11):3596-600. doi: 10.1007/s11999-013-3188-z. Epub 2013 Jul 27.

Wear of highly crosslinked polyethylene acetabular components.
Callary SA1, Solomon LB, Holubowycz OT, Campbell DG, Munn Z, Howie DW.
Acta Orthop. 2015 Apr;86(2):159-68. doi: 10.3109/17453674.2014.972890. Epub 2014 Oct 10.
Public notes

Contacts
Principal investigator
Name 67318 0
A/Prof David Campbell
Address 67318 0
Wakefield Orthopaedic clinic
270 Wakefield Street
Adelaide 5000
South Australia
Country 67318 0
Australia
Phone 67318 0
+61 8 82364196
Fax 67318 0
Email 67318 0
Hipknee@TPG.com.au
Contact person for public queries
Name 67319 0
A/Prof David Campbell
Address 67319 0
Wakefield Orthopaedic clinic
270 Wakefield Street
Adelaide 5000
South Australia
Country 67319 0
Australia
Phone 67319 0
+61 8 82364196
Fax 67319 0
Email 67319 0
woc@woc.com.au
Contact person for scientific queries
Name 67320 0
A/Prof David Campbell
Address 67320 0
Wakefield Orthopaedic clinic
270 Wakefield Street
Adelaide 5000
South Australia
Country 67320 0
Australia
Phone 67320 0
+61 8 82364196
Fax 67320 0
Email 67320 0
Hipknee@TPG.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary