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NCT06153511

Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation

Completed NA Last updated 1 December 2023
What this trial tests

NA trial testing Robot assisted spinal transpedicular fixation in SPINAL Fracture in 13 participants. Completed in 7 July 2023.

Timeline
16 November 2022
Primary endpoint
24 April 2023
7 July 2023

Quick facts

Lead sponsorCyber Surgery S.L.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment13
Start date16 November 2022
Primary completion24 April 2023
Estimated completion7 July 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Cyber Surgery S.L.

Who can join

Adults 18 to 85, any sex, with SPINAL Fracture or Vertebral Fractures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients requiring transpedicular screw fixation. The study, conducted in two different hospital centers, involves patients with vertebral fractures, spinal stenosis, kyphosis, and other related conditions. The primary objective is to determine screw accuracy by assessing the degree of screw invasion into the pedicle using the Gertzbein-Robbins scale, with a target of achieving 96% acceptable screw placement. Trained radiologists will evaluate the screw invasion into the pedicle. The study is scheduled to span 12 months and each intervention includes a 1-month follow-up. Throughout this time frame, patients will undergo regular assessments, and outcomes will be closely monitored.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for SPINAL Fracture

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06153511.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing