Clinical Utility and Gait Analysis of NextAR System AUS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantation of GMK Sphere with conventional instrumentation, Implantation of GMK Sphere using the NextAR guidance system.
- Who it may be relevant to
- Registry conditions: Total Knee Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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).
Overview
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.
Detailed description
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.
The aims of this study are:
* To 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 * To determine whether NextAR system data contributes to improving patient outcomes and knee kinematics following TKR surgery, by providing greater flexion range that is equivalent to native knee motion. * To assess clinical outcomes measured by standardised assessments, including radiographic evidence, the Forgotten Joint Score (FJS), the Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L) questionnaires. * Determining the kinematics of the replaced knee as measured by 3D gait analysis.
According to study protocol, clinical evaluation is performed preoperatively and postoperatively at 6 weeks, 6 months, 1, and 2 years with the use of the Forgotten Joint Score (FJS), Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L).
CT scan is performed preoperatively and at 6-weeks after surgery, while X-ray assessment is performed at baseline and at the 1-year follow up.
Interventions
- Device Implantation of GMK Sphere with conventional instrumentation
Implantation of GMK Sphere with conventional instrumentation (control group) - Device Implantation of GMK Sphere using the NextAR guidance system
Implantation of GMK Sphere using the NextAR guidance system (NextAR group)
Primary outcome measures
- Determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score [Time frame: pre-op, 6 weeks, 6 months, 1 year, 2 years]
Secondary outcome measures (4)
- To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L [Time frame: pre-op, 6 weeks, 6 months, 1 year, 2 years]
- Determining the kinematics of the replaced knee as measured by 3D gait analysis. [Time frame: pre-op, 1 year]
- To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score [Time frame: pre-op, 6 weeks, 6 months, 1 year, 2 years]
- To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee [Time frame: pre-op, 6 weeks, 6 months, 1 year, 2 years]
Eligibility criteria
Inclusion criteria
- End-stage osteoarthritis of the knee suitable for total knee arthroplasty.
- Aged over 18 years.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Australia · 1 center
- Fremantle Hospital — Fremantle
Identifiers
NCT: NCT05863741 · P02.022.01