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Trial registered on ANZCTR
Registration number
ACTRN12613000529741
Ethics application status
Approved
Date submitted
5/05/2013
Date registered
13/05/2013
Date last updated
20/09/2021
Date data sharing statement initially provided
20/09/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Computer assisted total knee arthroplasty: kinematic versus mechanical alignment
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Scientific title
In individuals undergoing total knee arthroplasty how does kinematic alignment compared to mechanical alignment effect post-operative pain, function, limb alignment, patient outcomes, and longevity of the prosthesis.
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Secondary ID [1]
282448
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Australia Online Forms for Research AU/1/1472111
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis
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Total Knee Arthroplasty
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Condition category
Condition code
Musculoskeletal
289400
289400
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0
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Osteoarthritis
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Surgery
289471
289471
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients will undergo an alternate alignment approach in total knee arthroplasty surgery known as kinematic alignment which aims to restore the knee to its normal pre-diseased alignment, in doing so match the prosthesis more closely to the ligamentous envelope which it must function. Computer navigation will be used. The surgery will take 60-90 mins in duration.
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Intervention code [1]
287095
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Treatment: Surgery
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Comparator / control treatment
Control group: These patients will undergo computer navigated total knee arthroplasty with the traditional neutral mechanical alignment which aims to achieve a neutral or straight alignment of the knee with a perpendicular joint line. The duration of the surgery will be 60-90 mins.
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Control group
Active
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Outcomes
Primary outcome [1]
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Limb, knee, and prosthesis alignments.
Pre-operative measurements will be calculated from the pre-operative radiologic films. Intra-operative alignment measures will be calculated direct from the computer assisted navigation system. Post-operative measurements will be calculated from post-operative radiologic films.
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Assessment method [1]
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Timepoint [1]
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Baseline, intra-operatively, 6 weeks post-operatively
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Primary outcome [2]
329007
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Questionnaire on preference for one joint over the other and perception of limb asymmetry. This questionnaire was designed specifically for the study and asked of the patients undergoing simultaneous bilateral total knee arthroplasty.
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Assessment method [2]
329007
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Timepoint [2]
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1 and 2 years post surgery.
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Secondary outcome [1]
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EQ5D (Validated outcome score)
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Assessment method [1]
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Timepoint [1]
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Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively
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Secondary outcome [2]
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WOMAC (Validated outcome score)
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Assessment method [2]
302756
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Timepoint [2]
302756
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Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively
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Secondary outcome [3]
302757
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Knee Society Score (Validated outcome score)
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Assessment method [3]
302757
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Timepoint [3]
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Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively
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Secondary outcome [4]
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Oxford Knee Score (Validated outcome score)
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Assessment method [4]
302758
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Timepoint [4]
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Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively
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Secondary outcome [5]
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Forgotten Joint Score (Validated outcome score)
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Assessment method [5]
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Timepoint [5]
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Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively
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Eligibility
Key inclusion criteria
Age 45-90
Severe osteoarthritis of a unilateral knee or bilateral knees for which conservative management has been unsuccessful.
Medically fit to undergo total knee arthroplasty
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Minimum age
45
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Revision total knee arthroplasty
Medically unfit for total knee arthroplasty
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified from those referred to participating orthopaedic surgeons for treatment of advanced symptomatic knee osteoarthritis. Participants will be give a verbal and written explanation of the trial and written informed consent will be obtained. Participants will be randomised to the intervention (kinematic alignment) and control (mechanical) groups.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online random number generator. Blinded allocation. Allocation concealment will be achieved using central randomisation by computer, and person selecting patient for inclusion will be unaware of allocation group
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
1/07/2013
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Actual
21/11/2013
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Date of last participant enrolment
Anticipated
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Actual
21/11/2019
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Date of last data collection
Anticipated
28/11/2022
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Actual
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Sample size
Target
250
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Accrual to date
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Final
224
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Mater Hospital Pimlico - Pimlico
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Recruitment postcode(s) [1]
6825
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4812 - Pimlico
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Funding & Sponsors
Funding source category [1]
287228
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Charities/Societies/Foundations
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Name [1]
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ORIQL (Orthopaedic Research Institute of Queensland)
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Address [1]
287228
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Suite 3 Level 2
Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 Qld
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Country [1]
287228
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
ORIQL (Orthopaedic Research Institute of Queensland)
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Address
Suite 3 Level 2
Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 Qld
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
285985
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Address [1]
285985
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Country [1]
285985
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289215
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Mater Hospital Townsville Ethics Committee
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Ethics committee address [1]
289215
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Mater Hospital Townsville 21-37 Fulham Rd Pimlico QLD 4810
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Ethics committee country [1]
289215
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Australia
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Date submitted for ethics approval [1]
289215
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07/05/2013
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Approval date [1]
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23/08/2013
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Ethics approval number [1]
289215
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EC00412
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Summary
Brief summary
The aim of this project is to compare two different total knee arthroplasty (TKA) approaches with regards to alignment. Traditionally TKA aimed to achieve a neutral or straight (mechanical) alignment of the knee with a perpendicular joint line. However studies have shown that rarely does this arrangement echo normal anatomy. In most individuals the mechanical axis of the limb is not neutral and the joint line is often slightly oblique. Given that up to 20-25% of patients are dissatisfied with their TKA outcomes due to pain and poor function with activities of daily living, there is much room for improvement. Kinematic alignment aims to restore the knee to its normal pre-diseased alignment, in doing so match the prosthesis more closely to the ligamentous envelope which it must function and therfore may improve post-operative kinematics and function. The gold standard for accuracy in TKA is computer assisted surgery and although mechanical versus kinematic alignment has been studied in a single randomised control trial, the surgery was performed without computer assistance. This study will compare outcomes of navigated kinematically aligned TKA versus navigated mechanically aligned TKA which uses computer assistance to ensure accurate positioning of the prosthesis. 250 patients will be chosen for the study. These patients will be selected by three surgeons involved with ORIQL as needing total knee arthroplasty and as indicated by clinical guidlines. There will be two study groups. Group A (200 patients) will be patients undergoing unilateral total knee replacement and group B will be those undergoing bilateral TKR. The participants in group A will be randomized to either mechanical or kinematic alignment. Group B (50 patients) will have one knee replaced kinematically and the other mechanically. Randomisation will apply to which knee is done first. The first replacement will be done kinematically and the second mechanically provided that any alignment difference between the two does not produced visual asymmetry. In this instance, the second knee will be done kinematically and the patient withdrawn from the trial. All patients will undergo the same protocol process for total knee arthroplasty. All other intra-operative and post-operative protocols will be the same for all patients. They will be followed up post-operatively at 2 weeks, 6 weeks, 6 months, and then yearly. Post-operative radiologic assessment will be that normally required following TKA. Outcome measures will include validated clinical pain and function scores such as the WOMAC score, EQ5D, Knee Society Score, the Oxford Knee Score, and the Forgotten Joint Score. Data collected will be analysed using statistical methods in order to find any statistically significant difference in results between the two alignment strategies
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Peter McEwen
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Address
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The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld
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Country
39802
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Australia
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Phone
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+61747799902
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Fax
39802
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Email
39802
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[email protected]
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Contact person for public queries
Name
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Andrea Grant
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Address
39803
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The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld
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Country
39803
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Australia
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Phone
39803
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+61747799902
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Fax
39803
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Email
39803
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[email protected]
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Contact person for scientific queries
Name
39804
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Andrea Grant
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Address
39804
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The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld
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Country
39804
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Australia
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Phone
39804
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+61747799902
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Fax
39804
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Email
39804
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Our research group has not yet come to an agreement on what data will be available, and also we would like to include this in the patient consent before sharing their individual participant data. This is in the process of being discussed.
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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
No additional documents have been identified.
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