ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12618000107224

Ethics application status

Approved

Date submitted

11/12/2017

Date registered

24/01/2018

Date last updated

3/12/2019

Date data sharing statement initially provided

3/12/2019

Date results provided

3/12/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Fixation of polyethylene knee replacement tibial components in patients with osteoarthritis aged 18-60

Scientific title

Migration characteristics of the Profix all-polyethylene tibial component in patients with osteoarthritis aged 18-60

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1206-5052

Trial acronym

Linked study record

Health condition

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

knee osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Routine total knee replacement using a Profix (Smith & Nephew, USA) implant. All-polyethylene implant used in all patients.

Standard surgical procedure of 60-90 minutes duration.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Historical control.Norgren, B., Dalen, T., and Nilsson, K. G.: All-poly tibial component better than metal-backed: a randomized RSA study. Knee. 11:189-196, 2004. Authors previous study used same implant and study design in patients aged greater than 60 years. Previous study randomised 21 patients to receive an all-polyethylene tibial component or a modular metal-backed component. Surgery performed in Umea 1999-2000

Control group

Historical

Outcomes

Primary outcome [1]

Migration of tibial component measured with radiostereometric analysis (RSA)

Timepoint [1]

Immediate post op, 12 months and 24 months
change made following 2 year results analysed. We do not have the resources for a 10-year review and will re=apply if they become available

happy to leave this open

Secondary outcome [1]

Excessive tibial migration:
Components classified as stable or unstable by a composite categorical endpoint determined by;
1. tibial components were classified into being non-migrating (stable) or continuously migrating (unstable) migration greater than 200um by RSA.
2. presence and size of radiolucent lines at the tibial component interface as described by the Knee Society assessment of plain films.

Timepoint [1]

immediate post operative, 1, 2 and 10 years

Eligibility

Key inclusion criteria

osteoarthritic patients booked to have knee replacement surgery

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

previous surgery
weight > 120kg
inflammatory arthritis
severe anatomical abnormalities
non-metropolitan residence

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)

not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

none

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

comparison to authors historical series of older patients

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

descriptive measures of migration
secondary analysis with comparison of means to historical controls

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/03/2006

Date of last participant enrolment

Anticipated

Actual

23/07/2009

Date of last data collection

Anticipated

23/07/2020

Actual

6/06/2012

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Calvary Wakefield Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

David Campbell

Address

Wakefield Orthopaedic Clinic
270 Wakefield Street
Adelaide
5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Wakefield Hospital Ethics Committee

Ethics committee address [1]

250 Wakefield street
Adelaide
South Australia   5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/08/2005

Approval date [1]

14/11/2005

Ethics approval number [1]

05 CHREC-1411

Summary

Brief summary

All-polyethylene (AP) tibial components in patients aged greater than 60 years have stable tibial migration patterns and favorable survival rates when compared to identical metal-backed (MB) designs. Tibial component fixation in patients aged less than 60 years was measured with radiostereometric analysis (RSA) and compared to a previous cohort of AP  and MB tibial components of identical design in patients aged greater than 60 years.
Methods
A prospective consecutive study examined tibial component migration in 21 patients aged less than 60 years undergoing a cemented total knee arthroplasty with an AP tibial component by RSA to 24 months. Results were compared to the authors previous series of 21 patients aged greater than 60 years that were randomized to either an AP or MB tibial component. The articulating geometry and stem design of the implants were identical as were the operative technique and post-operative regime
Results
At 2-years both age groups of patients implanted with an all-polyethylene component had stable migration patterns with no patient having greater than 0.2 degree rotation or 0.5mm maximum total point motion. Five of 11 metal-backed tibial components displayed continued migration between 1 and 2 years. Median internal/external rotation was greater with MB components; 0.15, 0.08, 0.28, AP < 60 years, AP > 60 years, and MB cohorts. Subsidence significantly greater for MB implants; median subsidence 0.17, 0.10, 0.25, AP < 60 years, AP > 60 years, and MB cohorts. Median maximum total point motion was greater for the MB cohort  0.34, 0.33, 0.61mm, AP < 60 years, AP > 60 years, and MB cohorts
Conclusions
Young patients implanted with an all-polyethylene tibial component had stable tibial migration patterns comparable to older patients with the same all-polyethylene implant. Regardless of age, all-polyethylene tibial components were at least as stable as metal-backed tibial components. The study will continue until 10-years.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof David Campbell

Address

Wakefield Orthopaedic Clinic
270 Wakefield Street
Adelaide
South Australia, 5000

Country

Australia

Phone

+61 8 8236 4196

Fax

+61 8 8236 4180

hipknee@tpg.com.au

Contact person for public queries

Name

Chris Schultz

Address

Wakefield Orthopaedic Clinic
270 Wakefield Street
Adelaide
South Australia 5000

Country

Australia

Phone

+61 8 8236 4196

Fax

+61 8 8236 4180

cschutz@woc.com.au

Contact person for scientific queries

Name

David Campbell

Address

Wakefield Orthopaedic Clinic
270 Wakefield Street
Adelaide
South Australia 000

Country

Australia

Phone

+61 8 8236 4196

Fax

+61 8 8236 4180

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

confidential patient information

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	All-polyethylene tibial components in young patients have stable fixation; a comparison RSA study.	2019	https://dx.doi.org/10.1016/j.knee.2018.12.003

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

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Documents added manually

Documents added automatically