Trial Review

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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
Date results information initially provided
20/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Computer assisted total knee arthroplasty: kinematic versus mechanical alignment
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.
Secondary ID [1] 282448 0
Australia Online Forms for Research AU/1/1472111
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis
 289064 0
Total Knee Arthroplasty 289130 0
Condition category
Condition code
Musculoskeletal 289400 289400 0 0
Osteoarthritis
Surgery 289471 289471 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287095 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 289509 0
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.
Timepoint [1] 289509 0
Baseline, intra-operatively, 6 weeks post-operatively
Primary outcome [2] 329007 0
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.
Timepoint [2] 329007 0
1 and 2 years post surgery.
Secondary outcome [1] 302659 0
EQ5D (Validated outcome score)
Timepoint [1] 302659 0
Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively
Secondary outcome [2] 302756 0
WOMAC (Validated outcome score)
Timepoint [2] 302756 0
Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively
Secondary outcome [3] 302757 0
Knee Society Score (Validated outcome score)
Timepoint [3] 302757 0
Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively
Secondary outcome [4] 302758 0
Oxford Knee Score (Validated outcome score)
Timepoint [4] 302758 0
Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively
Secondary outcome [5] 302759 0
Forgotten Joint Score (Validated outcome score)
Timepoint [5] 302759 0
Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively

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
Minimum age
45 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Revision total knee arthroplasty
Medically unfit for total knee arthroplasty

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)
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.
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/07/2013
Actual
21/11/2013
Date of last participant enrolment
Anticipated
Actual
21/11/2019
Date of last data collection
Anticipated
28/11/2022
Actual
Sample size
Target
250
Accrual to date
Final
224
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 968 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 6825 0
4812 - Pimlico

Funding & Sponsors
Funding source category [1] 287228 0
Charities/Societies/Foundations
Name [1] 287228 0
ORIQL (Orthopaedic Research Institute of Queensland)
Country [1] 287228 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
ORIQL (Orthopaedic Research Institute of Queensland)
Address
Suite 3 Level 2
Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 Qld
Country
Australia
Secondary sponsor category [1] 285985 0
None
Name [1] 285985 0
Address [1] 285985 0
Country [1] 285985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289215 0
Mater Hospital Townsville Ethics Committee
Ethics committee address [1] 289215 0
Mater Hospital Townsville
21-37 Fulham Rd
Pimlico QLD 4810
Ethics committee country [1] 289215 0
Australia
Date submitted for ethics approval [1] 289215 0
07/05/2013
Approval date [1] 289215 0
23/08/2013
Ethics approval number [1] 289215 0
EC00412

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39802 0
Dr Peter McEwen
Address 39802 0
The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld
Country 39802 0
Australia
Phone 39802 0
+61747799902
Fax 39802 0
Email 39802 0
[email protected]
Contact person for public queries
Name 39803 0
Mrs Andrea Grant
Address 39803 0
The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld
Country 39803 0
Australia
Phone 39803 0
+61747799902
Fax 39803 0
Email 39803 0
[email protected]
Contact person for scientific queries
Name 39804 0
Mrs Andrea Grant
Address 39804 0
The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld
Country 39804 0
Australia
Phone 39804 0
+61747799902
Fax 39804 0
Email 39804 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
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.


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.