ANZCTR - Registration

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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

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]

none

Universal Trial Number (UTN)

U1111-1185-2074

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoarthritis

Condition category

Condition code

Surgery

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]

Treatment: Devices

Intervention code [2]

Treatment: Surgery

Intervention code [3]

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]

RSA assessed femoral head migration as a measure of polyethylene wear.

Timepoint [1]

Two years, five years, and 10 years post surgery.

Secondary outcome [1]

Oxford hip scores

Timepoint [1]

One year and five years post surgery

Secondary outcome [2]

SF-12 scores

Timepoint [2]

One and five years post surgery

Secondary outcome [3]

Harris hip scores.

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

23/09/2005

Date of last participant enrolment

Anticipated

6/09/2009

Actual

6/09/2009

Date of last data collection

Anticipated

6/09/2019

Actual

6/09/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Styrker Australia

Address [1]

Stryker South Pacific
PO Box 970
Artarmon NSW 1570

Country [1]

Australia

Primary sponsor type

Individual

Name

David Campbell

Address

Wakefield Orthopaedic clinic
270 Wakefield Street
Adelaide5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Calvary Wakefield research and ethics committee

Ethics committee address [1]

Calvary wakeful Street Hospital
250 Wakefield Street 
Adelaide 5000
 South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/06/2004

Approval date [1]

21/03/2005

Ethics approval number [1]

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

A/Prof David Campbell

Address

Wakefield Orthopaedic clinic
270 Wakefield Street
Adelaide 5000
South Australia

Country

Australia

Phone

+61 8 82364196

Fax

Hipknee@TPG.com.au

Contact person for public queries

Name

David Campbell

Address

Wakefield Orthopaedic clinic
270 Wakefield Street
Adelaide 5000
South Australia

Country

Australia

Phone

+61 8 82364196

Fax

woc@woc.com.au

Contact person for scientific queries

Name

David Campbell

Address

Wakefield Orthopaedic clinic
270 Wakefield Street
Adelaide 5000
South Australia

Country

Australia

Phone

+61 8 82364196

Fax

Hipknee@TPG.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	The rate of wear of second-generation highly crosslinked polyethylene liners five years post-operatively does not increase if large femoral heads are used.	2016	https://dx.doi.org/10.1302/0301-620X.98B12.37682
Dimensions AI	Large articulations do not increase wear rates of thin second-generation highly cross-linked polyethylene liners at ten years	2023	https://doi.org/10.1302/2633-1462.411.bjo-2023-0124.r1

N.B. These documents automatically identified may not have been verified by the study sponsor.

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