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Clinical Utility and Gait Analysis of NextAR System AUS

Recruitingn/aAges 18 Years - anyAllMedacta International SA
NCT05863741 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Implantation of GMK Sphere with conventional instrumentation
  • Implantation of GMK Sphere using the NextAR guidance system
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Where

1 site
Fremantle Hospital
Fremantle, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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