Trial Review

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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
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
Secondary ID [1] 309079 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 329139 0
Condition category
Condition code
Musculoskeletal 326116 326116 0 0
Osteoarthritis
Surgery 326195 326195 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325519 0
Treatment: Surgery
Comparator / control treatment
The reference comparator is bony anatomic planning.
Control group
Active

Outcomes
Primary outcome [1] 333985 0
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.
Timepoint [1] 333985 0
intraoperative
Secondary outcome [1] 418948 0
Range of motion as assessed by the robotic system
Timepoint [1] 418948 0
intraoperative

Eligibility
Key inclusion criteria
Patients undergoing primary TKA
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24130 0
The Avenue Private Hospital - Windsor
Recruitment postcode(s) [1] 39639 0
3181 - Windsor

Funding & Sponsors
Funding source category [1] 313283 0
Charities/Societies/Foundations
Name [1] 313283 0
Melbourne Orthopaedic Group Research Trust
Country [1] 313283 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Melbourne Orthopaedic Group
Address
33 The Avenue
Windsor VIC 3181
Country
Australia
Secondary sponsor category [1] 315022 0
None
Name [1] 315022 0
Address [1] 315022 0
Country [1] 315022 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312513 0
Ramsay Health Care NSW / VIC Human Research Ethics Committee
Ethics committee address [1] 312513 0
Ethics committee country [1] 312513 0
Australia
Date submitted for ethics approval [1] 312513 0
27/02/2023
Approval date [1] 312513 0
Ethics approval number [1] 312513 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124926 0
A/Prof Timothy Lording
Address 124926 0
Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
Country 124926 0
Australia
Phone 124926 0
+61 3 95739694
Fax 124926 0
Email 124926 0
tlording@iinet.net.au
Contact person for public queries
Name 124927 0
Timothy Lording
Address 124927 0
Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
Country 124927 0
Australia
Phone 124927 0
+61 3 95739694
Fax 124927 0
Email 124927 0
tlording@iinet.net.au
Contact person for scientific queries
Name 124928 0
Timothy Lording
Address 124928 0
Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
Country 124928 0
Australia
Phone 124928 0
+61 3 95739694
Fax 124928 0
Email 124928 0
tlording@iinet.net.au

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
No additional documents have been identified.