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Clinical Utility and Gait Analysis of NextAR System AUS

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of May 2025 to May 12, 2025v3
  2. Interventions: Implantation of GMK Sphere (Device) to Implantation of GMK Sphere using the NextAR guidance system (Device), Implantation of GMK Sphere with conventional instrumentation (Device)v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05863741
Lead Sponsor Medacta International SA
Conditions Total Knee Arthroplasty
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov