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Clinical Evidence of Robot Guided vs. Navigated vs. Free Hand Lumbar Spinal Fusion

NCT02998060 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-10-22

No results posted yet for this study

Summary

Computer-based navigation systems were first introduced to spine surgery in 1995 and while they have been long established as standards in certain cranial procedures, they have not been similarly adopted in spine surgery. Designed to overcome some of the limitations of navigation-based technologies, robot-guided surgical systems have become commercially available to surgeons worldwide.These systems are rapidly challenging the gold standards.

The aim is to conduct a prospective randomized controlled trial. The randomized variable will be the screw placement technique used. One arm will be treated with lumbar fusion using robotic guidance (RG), one arm will receive the same procedure but with a free hand technique (FH) and the third arm will use navigation (NV) (CT or Fluoroscopy-assisted). Intraoperative screw revisions and revision surgery for screw malposition as well as clinical patient-reported outcomes to identify any such differences between these methods of screw insertion will be assessed.

Conditions

  • Spondylolisthesis
  • Intervertebral Disc Degeneration

Interventions

PROCEDURE

Pedicle Screw Placement

As a part of the lumbar spinal fusion procedure, posterior pedicle screws will be placed.

DEVICE

SpineAssist®/Renaissance® (Mazor Robotics Ltd. Caesarea, Israel)

This robot will be used to guide pedicle screws into their trajectories.

DEVICE

3D C-Arm (Ziehm Imaging, Nuremberg, Germany)

This 3D Fluoroscope will be used to navigate pedicle screws into their trajectories.

Sponsors & Collaborators

  • Marc Schröder

    lead OTHER

Principal Investigators

  • Victor E Staartjes, Stud. Med. · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-03-31
Completion
2019-05-31

Countries

  • Germany
  • Switzerland

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 NCT02998060 on ClinicalTrials.gov