Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000418471
Ethics application status
Approved
Date submitted
16/04/2025
Date registered
7/05/2025
Date last updated
29/05/2025
Date data sharing statement initially provided
7/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
CORI Robotics and Sensor-based Inertial Measurement Unit in Unicompartmental (Partial) Knee Arthroplasty
Scientific title
A Prospective Interventional Study of REAL INTELLIGENCE™ CORI™ and Sensor-Based Inertial Measurement Unit (IMU) in Unicompartmental Knee Arthroplasty (UKA) patients
Secondary ID [1] 314221 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 337124 0
Condition category
Condition code
Musculoskeletal 333543 333543 0 0
Osteoarthritis
Surgery 333615 333615 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, non-randomised, non-blinded, longitudinal study of early clinical outcomes of patients with osteoarthritis of the knee who are eligible for unicompartmental (partial) knee arthroplasty (UKA). The most suitable intervention for the patient will be chosen at physician discretion.

Participants in the intervention group will undergo UKA procedure with the robotic REAL INTELLIGENCE™ CORI™ unit performed by consultant orthopaedic surgeons. The CORI unit will be used in surgery and involves the use of bony landmarks and computer navigation trackers to more accurately work out alignment of bony cuts aiding better positioning of the implant over not using it. The approximate duration of a UKA procedure is 90 minutes. The robotic navigation technique is expected to add approximately 10 minutes to the procedure, therefore the total time of the operation will be approximately 100 minutes.
Intervention code [1] 330880 0
Treatment: Surgery
Comparator / control treatment
Participants in the comparator group will undergo conventional, non-robotic UKA procedure per the investigators’ preferred procedure. The surgery will be performed by consultant orthopaedic surgeons. The approximate duration of a UKA procedure is 90 minutes.
Control group
Active

Outcomes
Primary outcome [1] 341127 0
Complications in the early post-operative period (3 months following surgery)
Assessment method [1] 341127 0
Between-group comparisons of any post-operative complications recorded in patient medical records in the 3 months following surgery (includes inpatient stay, or subsequent re-presentation at hospital)
Timepoint [1] 341127 0
All complications up to 3 months following surgery. Complications will be assessed at 3 months following surgery to ensure complete capture.
Primary outcome [2] 341192 0
Gait analysis
Assessment method [2] 341192 0
Composite sensor-based Inertial Measurement Unit (IMU) metrics (knee flexion, impact load asymmetry, spatio-temporal gait)
Timepoint [2] 341192 0
Pre-operative (up to 90 days prior to surgery), post-surgery at Week 1, Week 2, Week 3, Week 4, and Week 6
Secondary outcome [1] 446369 0
Post-operative limb alignment
Assessment method [1] 446369 0
Hip-knee-ankle (HKA) angles measured using radiographic assessment at 6 weeks.
Timepoint [1] 446369 0
6 weeks post-surgery
Secondary outcome [2] 446718 0
Oxford knee Score
Assessment method [2] 446718 0
The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to assess perceived function and pain answered on a Likert scale. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Timepoint [2] 446718 0
Pre-operative (up to 90 days prior to surgery), 3 months post-surgery
Secondary outcome [3] 446719 0
Forgotten Joint Score (FJS-12)
Assessment method [3] 446719 0
The Forgotten Joint Score (FJS) comprises measures for the assessment of joint-specific patient reported outcomes. Participants are asked to rate their awareness of their knee arthroplasty in 12 questions with a five point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living (i.e., a higher score is a better outcome).
Timepoint [3] 446719 0
3 months post-surgery
Secondary outcome [4] 446720 0
EuroQol 5 Dimensions (EQ-5D-5L)
Assessment method [4] 446720 0
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The descriptive system (i.e., index score) is used to describe the participant's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate their health state by marking the most appropriate statement in each of the five areas. The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health.
Timepoint [4] 446720 0
Pre-operative (up to 90 days prior to surgery), 3 months post-surgery
Secondary outcome [5] 446721 0
Pain Visual Analogue Scale (VAS)
Assessment method [5] 446721 0
The Pain VAS scale consists of 2 sub-scales measuring pain at rest and pain with movement, with a range of 0 to 100, with a higher score indicating higher level of pain.
Timepoint [5] 446721 0
Pre-operative (up to 90 days prior to surgery), 3 months post-surgery
Secondary outcome [6] 446722 0
Satisfaction
Assessment method [6] 446722 0
Participants will be asked to rate their satisfaction with the procedure using a 5 point Likert scale.
Timepoint [6] 446722 0
3 months post-surgery
Secondary outcome [7] 446723 0
Surgical time
Assessment method [7] 446723 0
Operating time of each surgery from patient surgical records
Timepoint [7] 446723 0
Intraoperative

Eligibility
Key inclusion criteria
• Patient is deemed appropriate for a unicompartmental knee replacement.
• Patients are deemed skeletally mature (>18 years of age)
• The patient has a primary diagnosis of osteoarthritis (OA), avascular necrosis, functional deformity or fractures that are unmanageable using other techniques.
• The patient has intact collateral ligaments.
• The patient has signed the study specific, ethics-approved, Informed Consent document.
• The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• The patient is receiving UKA as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard UKA (e.g. stems, augments, osteotomy, or custom made devices).
• The patient is undergoing simultaneous bilateral knee arthroplasty.
• The patient has been diagnosed as having an active infection.
• The patient is morbidly obese (BMI greater than or equal to 41).
• Patient, in the opinion of the Investigators, has a cognitive, emotional, neurological or neuromuscular condition that would pre-empt their ability or willingness to participate in the study, or may interfere with UKA survival or outcome.
• Patient does not meet the indication, or is contraindicated, for UKA according to the knee system’s Instructions for Use (IFU).
• Patient is pregnant or breastfeeding at time of surgery.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size justification:
This study will follow 100 consenting participants undergoing 50 robotic assisted and 50 conventional UKA. The sample size was calculated using pilot data conducted by the study group for a TKA population (average impact asymmetry 8% vs 13.6% for RA-TKA and conventional TKA groups, respectively), and was powered to 0.80 to detect an alpha significance level of 0.05 with a pooled SD of 0.09 requiring a minimum sample of 42 individuals in each group. The final sample size was calculated to account for 10% drop out (expected rate of drop out from previous similar studies).

Statistical analysis plan:
The primary outcome data gathered from patients in each study group will be pooled and summarized. For the primary objective, a two-way analysis of variance (ANOVA) will be performed to determine differences between robotic-assisted and conventional UKA groups. A partial least squares regression analysis will be used to correlate sensor and oxford knee scoring metrics. Group wise comparisons and post-hoc analyses will be performed using non-parametric statistical methods following ANOVA testing. Independent two-sample t-test or Wilcoxon non-parametric rank-sum test will be used to compare the OKS, FJS, EQ-5D, VAS Pain and Satisfaction and scores between the robotic and conventional groups at all available visits.
For the secondary objectives, independent two-sample t-test or Wilcoxon non-parametric rank-sum test will be used to compare differences in length of stay, and chi-squared analyses will be used to compare proportional differences in complications. Learning curves will be analysed using a Cumulative Summation (CUSUM) method.
Adverse events will be tabulated separately and reviewed for any commonalities. Any revision surgery data from the study will be compared to the revision rates reported in the New Zealand Joint Registry report.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2025
Actual
15/05/2025
Date of last participant enrolment
Anticipated
15/05/2027
Actual
Date of last data collection
Anticipated
15/08/2027
Actual
Sample size
Target
100
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 26982 0
New Zealand
State/province [1] 26982 0
Auckland

Funding & Sponsors
Funding source category [1] 318738 0
Commercial sector/Industry
Name [1] 318738 0
Smith & Nephew Pty Ltd
Country [1] 318738 0
Australia
Primary sponsor type
University
Name
University of Auckland
Country
New Zealand
Secondary sponsor category [1] 321174 0
None
Name [1] 321174 0
Country [1] 321174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317351 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317351 0
Ethics committee country [1] 317351 0
New Zealand
Date submitted for ethics approval [1] 317351 0
02/10/2024
Approval date [1] 317351 0
17/03/2025
Ethics approval number [1] 317351 0
2025 EXP 20846

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 140770 0
Mr A. Paul Monk
Address 140770 0
University of Auckland, 8 Park Road, Grafton, Auckland 1023
Country 140770 0
New Zealand
Phone 140770 0
+64 9 4868900 43748
Email 140770 0
paul.monk@auckland.ac.nz
Contact person for public queries
Name 140771 0
Mei Lin Tay
Address 140771 0
University of Auckland, 8 Park Road, Grafton, Auckland 1023
Country 140771 0
New Zealand
Phone 140771 0
+64 9 4868900 43748
Email 140771 0
m.tay@auckland.ac.nz
Contact person for scientific queries
Name 140772 0
A. Paul Monk
Address 140772 0
University of Auckland, 8 Park Road, Grafton, Auckland 1023
Country 140772 0
New Zealand
Phone 140772 0
+64 9 4868900 43748
Email 140772 0
paul.monk@auckland.ac.nz

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be shared for privacy and confidentiality purposes.



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.