Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System

StatusTerminated
PhaseNot applicable
Started

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Record History

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  1. Stopped Trial terminated Sponsor's reason: The study was prematurely terminated despite completion of study activities, as final data analysis could not be conducted due to operational disruptions caused by the war in Gaza. These circumstances were beyond the sponsor's and site's control.
    • Study completion date changed from estimate of Dec 30, 2025 to Feb 23, 2026
    • Eligibility criteria expanded, about 10 words
    • Publications: details revised at 9 of 9 entries
  2. Minor Study completion date: Jun 30, 2025 to Dec 30, 2025v5
  3. Minor Study completion date: Jun 30, 2024 to Jun 30, 2025v4
  4. Minor Study completion date: Dec 31, 2023 to Jun 30, 2024v3
  5. Notable Primary completion date: Jul 31, 2022 to Dec 31, 2023v2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of the study is to assess screw deviation from pre-planned trajectory using the Mazor X robotic system in patients undergoing posterior thoracolumbar arthrodesis procedures between T2-S1.
Trial Details
NCT Number NCT05884593
Lead Sponsor Ohio State University
Collaborators: Medtronic
Conditions
(from sponsor)
Spinal Deformity, Spinal Infection, Trauma, Neoplastic Processes, Degenerative Spinal Conditions
Related terms Neoplastic Processes, Wounds and Injuries
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov