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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

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]

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

Total Knee Arthroplasty

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Surgery

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]

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]

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]

Baseline, intra-operatively, 6 weeks post-operatively

Primary outcome [2]

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]

1 and 2 years post surgery.

Secondary outcome [1]

EQ5D (Validated outcome score)

Timepoint [1]

Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively

Secondary outcome [2]

WOMAC (Validated outcome score)

Timepoint [2]

Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively

Secondary outcome [3]

Knee Society Score (Validated outcome score)

Timepoint [3]

Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively

Secondary outcome [4]

Oxford Knee Score (Validated outcome score)

Timepoint [4]

Baseline (pre-operatively), 6 weeks post-operatively, 6 months post-operatively

Secondary outcome [5]

Forgotten Joint Score (Validated outcome score)

Timepoint [5]

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]

Mater Hospital Pimlico - Pimlico

Recruitment postcode(s) [1]

4812 - Pimlico

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

ORIQL (Orthopaedic Research Institute of Queensland)

Address [1]

Suite 3 Level 2
Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 Qld

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Hospital Townsville Ethics Committee

Ethics committee address [1]

Mater Hospital Townsville
21-37 Fulham Rd 
Pimlico QLD 4810

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/05/2013

Approval date [1]

23/08/2013

Ethics approval number [1]

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

Dr Peter McEwen

Address

The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld

Country

Australia

Phone

+61747799902

Fax

Email

[email protected]

Contact person for public queries

Name

Andrea Grant

Address

The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld

Country

Australia

Phone

+61747799902

Fax

Email

[email protected]

Contact person for scientific queries

Name

Andrea Grant

Address

The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld

Country

Australia

Phone

+61747799902

Fax

Email

[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.