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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05863741
Registration number
NCT05863741
Ethics application status
Date submitted
26/04/2023
Date registered
18/05/2023
Date last updated
2/06/2023
Titles & IDs
Public title
Clinical Utility and Gait Analysis of NextAR System AUS
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Scientific title
Does Personalized Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilized Knee Arthroplasty? A Prospective, Randomized Study Investigating the Clinical Utility of the NextAR Navigation System (NextAR).
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Secondary ID [1]
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P02.022.01
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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:
Total Knee Arthroplasty
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Implantation of GMK Sphere with conventional instrumentation
Treatment: Devices - Implantation of GMK Sphere using the NextAR guidance system
control study - patients will be operated with conventional instrumentation
NextAR study - patients will be operated using the NextAR guidance system
Treatment: Devices: Implantation of GMK Sphere with conventional instrumentation
Implantation of GMK Sphere with conventional instrumentation (control group)
Treatment: Devices: Implantation of GMK Sphere using the NextAR guidance system
Implantation of GMK Sphere using the NextAR guidance system (NextAR group)
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score
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Assessment method [1]
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To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score
- Forgotten Joint Score measures the patient's ability to forget about the joint as a result of successful treatment and is based on the premise that the best arthroplasty is one the patient forgets. This score goes from a minimum of 0 to a maximum of 100 points.
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Timepoint [1]
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pre-op, 6 weeks, 6 months, 1 year, 2 years
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Secondary outcome [1]
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To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L
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Assessment method [1]
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To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L
The EQ5D-5L comprises of 6 questions survey that measures generic health-related quality of life. This score goes from a minimum of 0 to a maximum of 1 points.
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Timepoint [1]
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pre-op, 6 weeks, 6 months, 1 year, 2 years
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Secondary outcome [2]
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Determining the kinematics of the replaced knee as measured by 3D gait analysis.
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Assessment method [2]
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The purpose of the gait analysis will be to assess the variation in kinematics between the patients replaced knee (in both study groups) compared to normal knee kinematic data reported in the literature. The hypothesis being tested is that alteration of component position to give more normal ligament tension, will more resemble normal knee kinematics. (n=20) will be sufficient to conduct the gait analysis. These patients will be selected from the overall cohort for enrolment at 12 months post-surgery and matched for age, gender, BMI and osteoarthritis pattern. The comparison will involve comparing the average kinematic data values obtained in group 1 (NextAR data provided at surgery) vs the reported values in the literature and the same analysis will be repeated for patients in group 2 (NextAR data not provided at surgery).comparison will be made between the two groups in terms of which more closely replicates the kinematics of the non-arthritic knee
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Timepoint [2]
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pre-op, 1 year
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Secondary outcome [3]
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To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score
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Assessment method [3]
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To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score
the Oxford Knee Score is a questionnaire that has been specifically developed to assess knee function and pain. It is short, reproducible and extensively referenced in orthopaedic literature, making it a preferred tool for studies. This score goes from a minimum of 0 to a maximum of 48 points.
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Timepoint [3]
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pre-op, 6 weeks, 6 months, 1 year, 2 years
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Secondary outcome [4]
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To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee
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Assessment method [4]
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To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee
International Knee Documentation Committee is questionnaire that evaluates physical activity, level of pain and knee functionality in sporting activities. This score goes from a minimum of 0 to a maximum of 100 points.
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Timepoint [4]
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pre-op, 6 weeks, 6 months, 1 year, 2 years
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Eligibility
Key inclusion criteria
* End-stage osteoarthritis of the knee suitable for total knee arthroplasty.
* Aged over 18 years.
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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
* Unsuitable for TKR due to chronic infection, medical disease, inability to consent, inability to attend for post-operative follow-up, significant psychiatric issues, substance abuse issues
* Previous reconstructive/fracture/arthroplasty surgery on affected knee
* Active inflammation arthropathy
* Significant extra articular deformity
* Morbidly Obese (BMI >40)
* Pregnant women
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2026
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Fremantle Hospital - Fremantle
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Recruitment postcode(s) [1]
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- Fremantle
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medacta International SA
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.
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Trial website
https://clinicaltrials.gov/study/NCT05863741
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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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Ben Jeffcote
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Address
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Fremantle Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Arianna Girardi
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Address
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Country
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Phone
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+41 91 696 60 60
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05863741
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