Pedicle Screw Malposition in Spine Arthrodesis Surgeries With O-ARM-guided Navigation

Study acronym: NoHARM
StatusUnknown
PhaseNot applicable
Started

Record status This record was last updated September 25, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study site revised
    v4
  3. Start date: Jan 1, 2024 to Aug 1, 2024
    • Study sites: 0 to 1
    v3
  4. Study title shortened, about 4 wordsv2
  5. Study First Submitted
  • 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.
Background: Throughout the history of spinal deformity there have been continuous advances in the surgical treatment. Although many techniques have been successfully developed despite the anatomy complex, screw placement still remains difficult with a significant risk of misplaced implants. The O-ARM guided Navigation is a scanner that allows imaging of screws intraoperatively and could be a tool to facilitate screw revision and reduce the occurrence of misplaced implants. Methods: This is a prospective and randomized clinical study that will be carried out at the University Hospital of the Federal University of Piaui, which provides exclusive assistance to patients of the Unified Health System (UHS), in northeastern Brazil.
Trial Details
NCT Number NCT06020417
Lead Sponsor Federal University of Piaui
Conditions
(from sponsor)		 Spinal Fusion, Spinal Deformity, Spine Injury
Related terms Spinal Injuries
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov