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Trial registered on ANZCTR
Registration number
ACTRN12623000317695p
Ethics application status
Submitted, not yet approved
Date submitted
27/02/2023
Date registered
24/03/2023
Date last updated
24/03/2023
Date data sharing statement initially provided
24/03/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Can isolated referencing of femoral and tibial bone anatomy yield comparable ligament-balanced total knee arthroplasty to a robotic implantation technique? A Comparison of Two Planning Techniques
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Scientific title
Can isolated referencing of femoral and tibial bone anatomy yield comparable ligament-balanced total knee arthroplasty to a robotic implantation technique? A Comparison of Two Planning Techniques
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Secondary ID [1]
309079
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Nil known
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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
329139
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Condition category
Condition code
Musculoskeletal
326116
326116
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0
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Osteoarthritis
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Surgery
326195
326195
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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
The study intervention is total knee arthroplasty. This procedure will be performed once by an experienced orthopaedic knee surgeon in the operating room of a hospital. This procedure involves replacing the distal femoral bone and proximal tibial bone using a knee prosthesis. The procedure takes approximately 90 minutes to two hours.
Two planning techniques will be compared.
The first technique involves pre-operative assessment of the patient anatomy using magnetic resonance imaging and standing alignment films. A predicted best fit for the knee replacement components is determined by an engineer and modified by the orthopaedic consultant.
The second planning technique is a robotically assisted technique which involves intra-operative mapping of the patient joint surfaces and assessment of ligament tension. Implant position is then determined taking into account both factors.
In this study, the planned bony resections from the pre-operative planning will be input into the robotic system to determine the ligament laxity that would have resulted from following the first technique.
The robotic assisted technique will be then followed for all patients.
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Intervention code [1]
325519
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Treatment: Surgery
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Comparator / control treatment
The reference comparator is bony anatomic planning.
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Control group
Active
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Outcomes
Primary outcome [1]
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Assessment will be of the predicted ligament laxity that would be achieved if the anatomically based pre-operative plan were followed, as determined by the robotic system.
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Assessment method [1]
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Timepoint [1]
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intraoperative
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Secondary outcome [1]
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Range of motion as assessed by the robotic system
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Assessment method [1]
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Timepoint [1]
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intraoperative
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Eligibility
Key inclusion criteria
Patients undergoing primary TKA
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Minimum age
18
Years
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Maximum age
No limit
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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
(1) Documented refusal of the patient
(2) Patients < 18 years of age
(3) Inability to comply with required preoperative imaging or MRI requirements, or
(4) Medical contraindications to surgery. There will be no exclusion criteria regarding body mass index (BMI) or mechanical alignment
(5) Pregnancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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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
A priori power analysis was performed using an online calculator based on a 95% confidence interval (i.e., upper 95% CI-lower 95% CI) and a standard error of 0.05%. This indicated that a sample size of 50 is likely to show a significant result.
Statistical analysis will be performed using IBM SPSS software (version 29) (IBM Corp., Armonk, NY). A value of a = 0.05 is defined as the statistical significance threshold.
Categorical variables are given as frequency and percentage, while continuous variables are given as mean plus minus standard deviation. Categorical variables are compared using Pearson correlation. A chi-square test will be performed to compare the ligamentous laxity between 3D-printed cutting guides conducted femoral and tibial resections and robotic-assisted conducted femoral and tibial resections. Other standard calculations using statistical tests may be added as needed.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/04/2023
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Actual
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Date of last participant enrolment
Anticipated
29/12/2023
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Actual
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Date of last data collection
Anticipated
29/12/2023
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
24130
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The Avenue Private Hospital - Windsor
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Recruitment postcode(s) [1]
39639
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3181 - Windsor
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Funding & Sponsors
Funding source category [1]
313283
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Charities/Societies/Foundations
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Name [1]
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Melbourne Orthopaedic Group Research Trust
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Address [1]
313283
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33 The Avenue
Windsor VIC 3181
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Country [1]
313283
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Melbourne Orthopaedic Group
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Address
33 The Avenue
Windsor VIC 3181
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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]
315022
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Address [1]
315022
0
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Country [1]
315022
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Ramsay Health Care NSW / VIC Human Research Ethics Committee
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Ethics committee address [1]
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Level 7, Tower B, 7 Westbourne St, St Leonards NSW 2065
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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27/02/2023
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Approval date [1]
312513
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Ethics approval number [1]
312513
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Summary
Brief summary
Osteoarthritis (OA) is the most common joint disease of the elderly, with knee OA more common than hip or ankle OA. Primary total knee arthroplasty (TKA) has been used successfully for decades to treat osteoarthritis.
While a mechanical alignment (MA) of the prosthesis was initially pursued, this is increasingly being abandoned with the knowledge of the large variability of individual anatomy and knee biomechanics. New techniques involving patient-specific implantation techniques based on individual cutting guides and robotic-assisted implantation techniques have become more prevalent. While 3D-printed cutting guides are used to plan and perform osseous resections based on the individual bony anatomy, robotic-assisted techniques take into account the ligamentous stress ratios in flexion and extension.
The purpose of this study is to determine whether planning based solely on the patient's bony anatomy achieves similar medial and lateral ligamentous tension ratios after total knee arthroplasty as a robotic-assisted technique that implements resections based on ligamentous tension ratios and bony anatomy.
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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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A/Prof Timothy Lording
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Address
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Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
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Country
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Australia
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Phone
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+61 3 95739694
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Timothy Lording
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Address
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Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
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Country
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Australia
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Phone
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+61 3 95739694
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Timothy Lording
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Address
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Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
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Country
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Australia
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Phone
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+61 3 95739694
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Fax
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Email
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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
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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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