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Recruiting NCT05863741

Clinical Utility and Gait Analysis of NextAR System AUS

Trial Parameters

Condition Total Knee Arthroplasty
Sponsor Medacta International SA
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-05-15
Completion 2025-05-12
Interventions
Implantation of GMK Sphere with conventional instrumentationImplantation of GMK Sphere using the NextAR guidance system

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.

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

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