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RECRUITING
NCT05863741

Clinical Utility and Gait Analysis of NextAR System AUS

Sponsor: Medacta International SA

View on ClinicalTrials.gov

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.

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2022-05-15

Completion Date

2026-05

Last Updated

2025-09-29

Healthy Volunteers

No

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)

Locations (1)

Fremantle Hospital

Fremantle, Australia