Clinical Utility and Gait Analysis of NextAR System AUS
NCT ID: NCT05863741
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-05-15
2026-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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control study
patients will be operated with conventional instrumentation
Implantation of GMK Sphere with conventional instrumentation
Implantation of GMK Sphere with conventional instrumentation (control group)
NextAR study
patients will be operated using the NextAR guidance system
Implantation of GMK Sphere using the NextAR guidance system
Implantation of GMK Sphere using the NextAR guidance system (NextAR group)
Interventions
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Implantation of GMK Sphere with conventional instrumentation
Implantation of GMK Sphere with conventional instrumentation (control group)
Implantation of GMK Sphere using the NextAR guidance system
Implantation of GMK Sphere using the NextAR guidance system (NextAR group)
Eligibility Criteria
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Inclusion Criteria
* Aged over 18 years.
Exclusion Criteria
* Previous reconstructive/fracture/arthroplasty surgery on affected knee
* Active inflammation arthropathy
* Significant extra articular deformity
* Morbidly Obese (BMI \>40)
* Pregnant women
18 Years
ALL
No
Sponsors
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Medacta International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Ben Jeffcote
Role: PRINCIPAL_INVESTIGATOR
Fremantle Hospital
Locations
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Fremantle Hospital
Fremantle, , Australia
Countries
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Central Contacts
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Facility Contacts
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Ben Jeffcote
Role: primary
Other Identifiers
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P02.022.01
Identifier Type: -
Identifier Source: org_study_id
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