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

NCT02998060 · Marc Schröder · Updated 22 Oct 2018

What is being tested
Pedicle Screw Placement; SpineAssist®/Renaissance® (Mazor Robotics Ltd. Caesarea, Israel); 3D C-Arm (Ziehm Imaging, Nuremberg, Germany)
For
Spondylolisthesis; Intervertebral Disc Degeneration
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 17 years to 79 years. The full rules are on the registry page.
Where
Germany, Switzerland (2 sites)
When
Starts or started 1 Jan 2019, ends May 2019. Registered 20 Dec 2016.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT02998060

Sites

  • Universitätsmedizin Göttingen Georg-AugustGöttingen, Lower Saxony, Germany
  • University Hospital GenevaGeneva, Switzerland