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

NCT06153511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-12-01

No results posted yet for this study

Summary

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.

Conditions

  • SPINAL Fracture
  • Vertebral Fractures
  • Spinal Stenosis
  • Kyphosis
  • Lumbar Spinal Stenosis
  • Thoracolumbar Kyphosis

Interventions

PROCEDURE

Robot assisted spinal transpedicular fixation

Surgical technique which joins two or more vetebrae with screws and rods to prevent any relative movement between them. It is a major surgery that usually lasts several hours and in which the patient is subjected to general anesthesia. The screws to be placed go through a narrow area of the vertebra known as the pedicle. Each patient will undergo a singular intervention.

Sponsors & Collaborators

  • Cyber Surgery S.L.

    lead INDUSTRY

Principal Investigators

  • Nicolás M. Samprón Lebed, Neurosurgeon · Hospital Donostia

  • Iñigo C. Pomposo Gastelu, Neurosurgeon · Hospital de Cruces

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2023-04-24
Completion
2023-07-07

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06153511 on ClinicalTrials.gov