Clinical Utility and Gait Analysis of NextAR System AUS
NCT05863741 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2025-09-29
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.
Conditions
- Total Knee Arthroplasty
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)
Sponsors & Collaborators
-
Medacta International SA
lead INDUSTRY
Principal Investigators
-
Ben Jeffcote · Fremantle Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-15
- Primary Completion
- 2025-05-12
- Completion
- 2026-05-31
Countries
- Australia
Study Locations
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