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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
22/11/2022
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] 290536 0
none
Universal Trial Number (UTN)
Trial acronym
Knee-fix
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 300961 0
Condition category
Condition code
Surgery 300797 300797 0 0
Surgical techniques
Musculoskeletal 300798 300798 0 0
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] 296421 0
Treatment: Surgery
Intervention code [2] 296422 0
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] 300215 0
radiographic assessment of the bone/prostheses interface radiolucencies on plain X-Rays
Timepoint [1] 300215 0
24 months, 5 years and 10 years after surgery
Secondary outcome [1] 329417 0
Oxford Knee Score
Timepoint [1] 329417 0
12 months, 24 months, 5 years and 10 years after surgery
Secondary outcome [2] 329418 0
Forgotten Knee Score
Timepoint [2] 329418 0
12 months, 24 months, 5 years and 10 years after surgery
Secondary outcome [3] 329420 0
EQ-5D-3L
Timepoint [3] 329420 0
12 months, 24 months, 5 years and 10 years after surgery
Secondary outcome [4] 329421 0
VAS pain
Timepoint [4] 329421 0
12 months, 24 months, 5 years and 10 years after surgery
Secondary outcome [5] 377422 0
International Knee Society score
Timepoint [5] 377422 0
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?
No
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
6/09/2017
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] 8397 0
New Zealand
State/province [1] 8397 0
auckland

Funding & Sponsors
Funding source category [1] 294992 0
Charities/Societies/Foundations
Name [1] 294992 0
Orthopaedic Education and Research Fund- Three Harbours Health Foundation
Country [1] 294992 0
New Zealand
Funding source category [2] 304409 0
Commercial sector/Industry
Name [2] 304409 0
Stryker
Country [2] 304409 0
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] 293811 0
None
Name [1] 293811 0
Address [1] 293811 0
Country [1] 293811 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296346 0
Southern Health and Disability Ethics Committee, New Zealand
Ethics committee address [1] 296346 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6140
Ethics committee country [1] 296346 0
New Zealand
Date submitted for ethics approval [1] 296346 0
24/11/2016
Approval date [1] 296346 0
23/12/2016
Ethics approval number [1] 296346 0

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 70450 0
Mr Simon Young
Address 70450 0
Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Auckland
Country 70450 0
New Zealand
Phone 70450 0
+64 94868900
Fax 70450 0
Email 70450 0
[email protected]
Contact person for public queries
Name 70451 0
Simon Young
Address 70451 0
Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Auckland
Country 70451 0
New Zealand
Phone 70451 0
+64 94868900
Fax 70451 0
Email 70451 0
[email protected]
Contact person for scientific queries
Name 70452 0
Simon Young
Address 70452 0
Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Country 70452 0
New Zealand
Phone 70452 0
+64 94868900
Fax 70452 0
Email 70452 0
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Knee-Fix study: study protocol for a randomised controlled trial evaluating cemented and cementless components in total knee arthroplasty.2022https://dx.doi.org/10.1186/s13063-022-06974-7
N.B. These documents automatically identified may not have been verified by the study sponsor.