ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001624471

Ethics application status

Approved

Date submitted

16/11/2016

Date registered

24/11/2016

Date last updated

1/12/2024

Date data sharing statement initially provided

28/11/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Knee-Fix study (Cemented vs Uncemented Total Knee Replacement)

Scientific title

Knee-Fix study : A prospective, randomised, controlled trial of cemented vs uncemented total knee replacement. A study comparing Stryker Triathlon TKR

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Knee-fix

Linked study record

Health condition

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

knee osteoarthritis

Condition category

Condition code

Surgery

Surgical techniques

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a prospective, randomized, longitudinal study of the clinical outcomes of patients with osteoarthritis of the knee treated by two different philosophies for knee joint replacement. Participants will be treated using either the Stryker cemented or uncemented Triathlon Total Knee System for Total Knee Arthroplasty (TKA). The approximate duration of the procedure is 90 minutes and will be performed by consultant orthopaedic surgeons. For both knee systems the surgical technique is the same, but differ in whether cement is used at the bony interface or trabecular metal/porous metal gritted surface is used

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

The comparator treatment is the Cemented Stryker Triathlon Total Knee System for Total Knee Arthroplasty (TKA) implanted using Stryker PrecisioN v4.0 Knee Navigation (control). The navigation technique adds approximately 10 minutes to the procedure therefore the total time of the operation will be approximately 90 minutes. It involves the use of bony landmarks and computer navigation trackers to more accurately work out alignment of bony cuts aiding better positioning of the implant over not using it. The operations will be performed by consultant orthopaedic surgeons.

Control group

Active

Outcomes

Primary outcome [1]

radiographic assessment of the bone/prostheses interface radiolucencies on plain X-Rays

Timepoint [1]

24 months, 5 years and 10 years after surgery

Secondary outcome [1]

Oxford Knee Score

Timepoint [1]

12 months, 24 months, 5 years and 10 years after surgery

Secondary outcome [2]

Forgotten Knee Score

Timepoint [2]

12 months, 24 months, 5 years and 10 years after surgery

Secondary outcome [3]

EQ-5D-3L

Timepoint [3]

12 months, 24 months, 5 years and 10 years after surgery

Secondary outcome [4]

VAS pain

Timepoint [4]

12 months, 24 months, 5 years and 10 years after surgery

Secondary outcome [5]

International Knee Society score

Timepoint [5]

24 months, 2 years and 5 years after surgery

Eligibility

Key inclusion criteria

* The patient is a male or non-pregnant female between the ages of 40-75 years.
* Patient is deemed appropriate for a cruciate retaining knee replacement.
* The patient has a primary diagnosis of osteoarthritis (OA).
* The patient has intact collateral ligaments.
* The patient has signed the study specific, ethics-approved, Informed Consent document.
* The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Minimum age

40 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
* Patient has had a previous osteotomy around the knee.
* The patient is morbidly obese (BMI greater than 41).
* The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
* The patient has a varus/valgus malalignment greater than 20 degrees (relative to mechanical axis).
* The patient has a fixed flexion deformity greater than 20 degrees.
* The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* The patient has a systemic or metabolic disorder leading to progressive bone deterioration or poor bone quality.
* The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
* Patient has a cognitive impairment, an intellectual disability or a mental illness.
* Patients NOT undergoing patellar resurfacing
* The patient is pregnant.

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)

sealed opaque envelopes

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

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

We have based our sample size calculation on a non-inferiority test , as the new technique has some advantage and can be accepted if it is not worse than the standard TKR technique in the proportion of ‘non-progressive medical radiolucent lines’ by a certain value. In that paper, if you think 3% of ‘non-progressive medical radiolucent lines’ (at 5 years) is acceptable, then you will need to have 150 patients each group, with a power of 80% and at 95% confidence level. This actually means an 9% difference (12%-3%=9%) is acceptable, given the advantage gain using the new TKR technique. Additionally, to account for a 5% loss to follow up and rounding to whole numbers results in a final sample of 160 patients in each arm.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/02/2017

Actual

5/09/2017

Date of last participant enrolment

Anticipated

1/04/2020

Actual

17/03/2020

Date of last data collection

Anticipated

1/04/2030

Actual

Sample size

Target

320

Accrual to date

Final

316

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Orthopaedic Education and Research Fund- Three Harbours Health Foundation

Address [1]

Orthopaedic Education and Research Fund
Three Harbours Health Foundation
Private Bag 93-503
Takapuna
Auckland 0622
NZ

Country [1]

New Zealand

Funding source category [2]

Commercial sector/Industry

Name [2]

Stryker

Address [2]

8 Herbert St, St Leonards NSW 2065, Australia

Country [2]

Australia

Primary sponsor type

Hospital

Name

North Shore Hospital Waitemata DHB

Address

North Shore Hospital
124 Shakespeare Road
Takapuna
Auckland 0622
New Zealand

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee, New Zealand

Ethics committee address [1]

Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

24/11/2016

Approval date [1]

23/12/2016

Ethics approval number [1]

Summary

Brief summary

This  prospective, randomized, longitudinal  clinical  trial  is to  assess the early durability and clinical reliability of a highly porous metal tibial component versus a traditional cemented modular tibial component in Total Knee Replacement (TKR). We are looking to answer the following questions: (1) Is TKA with an uncemented highly porous metal tibial component as reliable clinically as TKR with a  cemented  tibial  component  (as  judged  by  health status and functional outcome measures, complications, and reoperations)? (2) Is TKR with an uncemented highly porous metal tibial component as durable as TKA with a standard cemented tibial component (as judged by 5-year survivorship)?

There will be 1 site (North Shore Hospital, Auckland), 1 Principal Investigator and 6 co-Investigators for this study. A maximum of 160 cases will be enrolled in each group, for a total of 320 patients. It is expected that participants will be recruited over a 24 month period. Total duration of the study is expected to be 10 years.

The study consists of two groups:
1.	Intervention Group: Treatment by total knee replacement using Stryker Triathlon uncemented TKR with uncemented patellar resurfacing;

2.	Control Group: Treatment by total knee replacement using Stryker Triathlon Cemented TKR with cemented patellar resurfacing

Pre-operatively, all participants will be required to have standard Knee X Rays (AP/M-L and Skyline view of patella.

All participants (control and intervention groups) will be requested to attend visits pre- operatively and post-operatively at 6 weeks, 12 months, 24 months, 5 years and 10 years. At these visits participants will complete assessments relating to quality of life, pain and functional outcome. In addition, participants will have standard knee X-rays taken pre- operatively and post-operatively. A further follow up visit at 5 and 10 years, to collect longer term data on radiographic and patient outcomes including the secondary objectives of revision rate, device-related adverse events and re-operation rates.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Simon Young

Address

Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Auckland

Country

New Zealand

Phone

+64 94868900

Fax

simon.young@auckland.ac.nz

Contact person for public queries

Name

Simon Young

Address

Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Auckland

Country

New Zealand

Phone

+64 94868900

Fax

simon.young@auckland.ac.nz

Contact person for scientific queries

Name

Simon Young

Address

Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622

Country

New Zealand

Phone

+64 94868900

Fax

simon.young@auckland.ac.nz

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 Knee-Fix study: study protocol for a randomised controlled trial evaluating cemented and cementless components in total knee arthroplasty.	2022	https://dx.doi.org/10.1186/s13063-022-06974-7

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