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Trial registered on ANZCTR


Registration number
ACTRN12620001242910
Ethics application status
Approved
Date submitted
13/07/2020
Date registered
20/11/2020
Date last updated
16/03/2022
Date data sharing statement initially provided
20/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation into the factors that influence knee mechanics following ligament-retaining, computer assisted knee replacement surgery.
Scientific title
Investigation into the factors that drive knee kinematics in severe osteoarthritis patients undergoing cruciate retaining kinematic computer assisted total knee arthroplasty: An Observational Case Series.
Secondary ID [1] 301756 0
MPM-19
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 318215 0
Total Knee Arthroplasty 318643 0
Condition category
Condition code
Musculoskeletal 316225 316225 0 0
Osteoarthritis
Surgery 316653 316653 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will prospectively undergo Kinematically Aligned (KA) Cruciate Retaining Computer Assisted Surgery (CAS). During surgery, the CAS (navigation) will be used to record a series of measurements or distances (mm) between anatomical landmarks of the patients native anatomy, and post surgery. The distances represent a 'laxity' assessment of each structure under observation in the knee. Intraoperative pressures and the direction of condylar movement will be measured during the time of prosthesis implantation by an Orthosensor device. Pre and post-operative radiographs will be taken and measured for comparison (and validation of) Intraoperative measures reported by CAS. Iliotibial tightness will be measured by the surgeon under anaesthesia, prior to surgically prepping the patient for surgery. It is anticipated that the additional ITB assessment and intraoperative measures using Navigation will add 10 minutes to the total surgical time; total surgical time is anticipated between one to two hours.
Patients range of motion and radiographic investigations as well as Patient Report Outcomes Questionnaires will be recorded pre operative, 6months and 2 years postoperative as per surgeons standard of care. The validated PROMS selected for this study include Euroquol 5D (EQ-5D), Knee Arthroplasty Outcome Score (KOOS Jnr), Knee Society Score (KSS) and the Forgotten Joint Score (FJS).
Should a patient choose to not enrol in the study, they too will undergo Kinematically Aligned (KA) Cruciate Retaining Computer Assisted Surgery as this is the surgeons standard of care surgical technique.
Intervention code [1] 318053 0
Not applicable
Comparator / control treatment
The operative knee is acting as it's own control.

The investigating surgeon routinely collects intraoperative data on all arthroplasty patients as standard practice. The data collected includes pre and postoperative joint alignment, ligament laxity, kinematic curve measurements recorded by Navigation.

Prospective data may be compared to existing data sets as a comparator.
Control group
Active

Outcomes
Primary outcome [1] 324416 0
1. Determine the influence on medial pivot by tensioning Posterior Cruciate Ligament (PCL) tension. The presence of Pivot Shift will be determined by the tracking pad output from the use of the Orthosensor insert. This result will be compared to the information the CAS system routinely produces during surgery.
Timepoint [1] 324416 0
Outcome of effect on pivot will be assessed on day of surgery using the navigation system values.
Primary outcome [2] 324779 0
Magnitude of rollback by manipulating medial and lateral collateral ligaments (MCL and LCL respectively), measured by CAS and orthopaedic sensor device, Orthosensor (Verasense).
Timepoint [2] 324779 0
Outcome will be measured intraoperatively on day of surgery.
Primary outcome [3] 324780 0
Influence of Iliotibial band (ITB) tightness on Patellofemoral function (PF), as measured by tibial tuberosity (TT) to trochlear groove (TG). The tibial tuberosityto trochlear groove offset (TT-TG) will be used as a surrogate for patellofemoral alignment. The offset is measured by using CAS point-to-point registration tool.
Timepoint [3] 324780 0
ITB tightness will be measured intraoperatively on day of surgery.
Secondary outcome [1] 384576 0
Examine the post-operative function at 2-year follow-up (of the KA TKA balanced interoperatively usingboth CAS and Orthosensor cohort) by assessing range of motion (goniometer) and patient reported outcome measures listed below.
Timepoint [1] 384576 0
2 years follow up after surgery
Secondary outcome [2] 384577 0
Post operative pain will be assessed using the Oxford knee Score. The Oxford knee score is patient administered, disease specific questionnaire that assesses pain & function of the knee in relation to different activities of daily life.
Timepoint [2] 384577 0
Proms collected pre op, 6 months and 2 years post operative
Secondary outcome [3] 384579 0
3. Determine the reliability of an intra-operative CAS technique for assessing PCL laxity. Reliability of the CAS technique for assessing PCL laxity will be assessed by comparing the data collected using the CAS to Orthosensor values. A Verasense insert will be used as an independent measure of intra-operative ligament tension and assessment of knee motion to graphically assess the presence of rollback and pivot in relation to tibial rotation (normally reported by the CAS).
Timepoint [3] 384579 0
CAS measurements are taken on the day of surgery, as are Orthosensor.
Secondary outcome [4] 384580 0
4. Examine the general health outcome of the patient following surgery with PROM EQ-5D-3L. This is a standardized patient-completed instrument for use as a measure of health outcome. It consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Timepoint [4] 384580 0
Proms collected pre op, 6 months and 2 years post operative
Secondary outcome [5] 385719 0
Post operative function will be assessed by using the Forgotten Joint Score (FJS). The Forgotten Joint Score is a twelve-item, self-reported assessment of how aware recipients of hip and knee joint replacement are of their joint in everyday life.
Timepoint [5] 385719 0
Proms collected pre op, 6 months and 2 years post operative
Secondary outcome [6] 387789 0
Knee Injury and Osteoarthritis Outcome Score Junior (KOOS JR): this is a self administrating survey form which assesses the patient's opinion about their knee and associated problems.
Timepoint [6] 387789 0
Measured preoperatively, 6 and 24 months post surgery.
Secondary outcome [7] 387790 0
Adverse Events will be monitored and recorded as part of the patients ongoing clinical care. Conditions specifically pertinent to the study will involve joint stiffness requiring manipulation under anaesthesia at 6 weeks post op, joint infection and re-operations.
Timepoint [7] 387790 0
Patients will be monitored out to 24 months from time of surgery.

Eligibility
Key inclusion criteria
• The patient is a male or non-pregnant female.
• The patient is aged between 45-90 years.
• Patient suffers from severe osteoarthritis.
• The patient has signed the study specific, HREC-approved, Informed Consent document and is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
• The patient has an intact PCL and is a suitable candidate for a CR TKA (based on the Investigator’s clinical judgment).
Minimum age
45 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis)
• Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient’s capacity to consent to research and the ability to participate in it.
• Prior injury / surgery to the PCL
• The patient is medically unfit for TKA.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Inter and intra observer variability measures will be used to assess the reliability of the PCL function assessment. Two observers with radiology training will make three independent assessments of the pre- and post-op x-rays. The intra-observer variability will be measured using the Bland-Altman method using the mean and standard deviation of each observer. The inter observer variability will be measured using the interclass correlation coefficient, which is interpreted assessing the range between (-)1 and 1; agreement is stronger when interclass correlation coefficient is equal to 1 or (-)1 and weak when equal to 0. The true value of both the pre- and post-operative radiograph measures will be taken as the intra-operative PD offset (at exposure and during trialing) as calculated by the Precision CAS platform.
The presence of the medial pivot and balance data confirmed with the Verasense and Precision CAS platform is likely to be very consistent and will be presented as categorical data (eg. post op tibial internal rotation (yes/no) vs. Verasense medial pivot (yes / no). The categorical data will be evaluated as frequency and percentage distributions and analyzed using Fischers exact test or Chi-squared test with 2-way contingency.
The Pearson correlation coefficient will be used to determine the relationship between ligament laxity and knee kinematics. Mean values will be analyzed using the two-tailed Student’s t-test and the one-way analysis of variance (ANOVA) test for normally distributed data and the Mann–Whitney and Kruskal–Wallis tests for non-parametric data. ANOVA and Kruskal-Wallis p-values will be adjusted for multiple comparisons using the Sidak correction. The correlations of interest are:
• Collateral (laxity assessment) and PCL balance (PD measure) and M/L Versense compartmental load measurements correlated with magnitude of medial pivot
• Tibial internal rotation correlated with medial pivot in balanced kinematic Cruciate Retaining Total Knee Arthroplasty
• Change in TT-TG (at exposure and trialing) recorded at both 90° and full extension correlated with medial pivot magnitude to assess patella-femoral function.
Paired t-tests for normally distributed data, or paired Wilcoxon test for non-parametric data, will be used to evaluate OKS, EQ-5D, FJS, KSS and KOOS from pre-op and between each visit for all available visits, depending on the data type. Please note that the test we intend on using will be dependent on the distribution of the data collected following appropriate normality testing. Adjustments will be made for multiple testing at each level.
Adverse events will be tabulated separately as numbers of events and as percentages of participants. The data will be summarized, and comparisons presented according to general complications, local complications, device-related complications, revisions/removals, loosening and pain.
A p value of = 0.05 is accepted as indicating a statistically significant difference for all statistical tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/11/2020
Actual
10/06/2020
Date of last participant enrolment
Anticipated
1/12/2022
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
40
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 30735 0
4810 - Townsville
Recruitment postcode(s) [2] 30736 0
4807 - Ayr
Recruitment postcode(s) [3] 30737 0
4820 - Charters Towers

Funding & Sponsors
Funding source category [1] 306187 0
Commercial sector/Industry
Name [1] 306187 0
Stryker Australia Pty Ltd
Country [1] 306187 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orthopaedic Research Institute of Queensland
Address
7 Turner Street, Pimlico Townsville, QLD 4812
Country
Australia
Secondary sponsor category [1] 306660 0
None
Name [1] 306660 0
Address [1] 306660 0
Country [1] 306660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306399 0
The Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 306399 0
Ethics committee country [1] 306399 0
Australia
Date submitted for ethics approval [1] 306399 0
17/12/2019
Approval date [1] 306399 0
05/05/2020
Ethics approval number [1] 306399 0
HREC/MML/59680

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

Contacts
Principal investigator
Name 103750 0
Dr Peter McEwen
Address 103750 0
North Queensland Knee
Mater Health Services North Queensland Medical Suites
Fulham Rd Pimlico
Townsville, Queensland 4812
Country 103750 0
Australia
Phone 103750 0
+61 07 47794788
Fax 103750 0
Email 103750 0
[email protected]
Contact person for public queries
Name 103751 0
Andrea Grant
Address 103751 0
Orthopaedic Research Institute of Queensland
7 Turner Street, Pimlico
Townsville Queensland 4812
Country 103751 0
Australia
Phone 103751 0
+61 0747550564
Fax 103751 0
Email 103751 0
[email protected]
Contact person for scientific queries
Name 103752 0
Andrea Grant
Address 103752 0
Orthopaedic Research Institute of Queensland
7 Turner Street Pimlico
Townsville, Queensland 4812
Country 103752 0
Australia
Phone 103752 0
+61 0747550564
Fax 103752 0
Email 103752 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


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.