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

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ClinicalTrials.gov Identifier: NCT02998060
Recruitment Status : Not yet recruiting
First Posted : December 20, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Marc Schröder, Bergman Clinics

Brief 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.


Condition or disease Intervention/treatment Phase
Spondylolisthesis Intervertebral Disc Degeneration Procedure: Pedicle Screw Placement Device: SpineAssist®/Renaissance® (Mazor Robotics Ltd. Caesarea, Israel) Device: 3D C-Arm (Ziehm Imaging, Nuremberg, Germany) Not Applicable

Detailed Description:

A decade ago, minimally invasive surgery (MIS) was considered a promising development in spine surgery, yet the value of the pioneering technologies was questionable. With the growing number of experienced MIS surgeons, the influx of evidence in favour of MIS is rapidly increasing. This makes a compelling argument towards MIS offering distinct clinical benefits over open approaches in terms of blood loss, length of stay, rehabilitation, cost-effectiveness and perioperative patient comfort. Due to the limited or inexistent line-of-sight in MIS procedures, surgeons need to rely on imaging, navigation, and guidance technologies to operate in a safe and efficient manner. Therefore, a plethora of new and ever improving navigational systems have been developed. These systems allow a consistent level of safety and accuracy, on par with results achieved by very experienced free hand surgeons, with a reasonably short learning curve.

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 surgery has become commercially available to surgeons worldwide, like SpineAssist® (Mazor Robotics Ltd. Caesarea, Israel) and the recently launched ROSA™ Spine (Zimmer-Biomet, Warsaw, Indiana, USA). These systems are rapidly challenging the gold standards.

SpineAssist®, and its upgraded version, the Renaissance®, provides a stable drilling platform and restricts the surgeon's natural full range of motion to 2 degrees of freedom (up/down motion and yaw in the cannula). The system's guidance unit moves into the trajectory based on exact preoperative planning of pedicle screws, while accounting for changes in intervertebral relationships such as due to distraction, cage insertion or changes between the supine patient position in the preoperative CT and the prone patient on the operating table. Published evidence on robot-guided screw placement has demonstrated high levels of accuracy with most reports ranging around 98% of screws placed within the pedicle or with a cortical encroachment of less than 2 mm.

Although the reliability and accuracy of robot-guided spine surgery have been established, the actual benefits for the patient in terms of clinical outcomes and revision surgeries remain unknown.

The investigators recently conducted a cohort study that showed some evidence that robotic guidance lowers the rate of intraoperative screw revisions and implant related reoperations compared to free hand procedures, while achieving comparable clinical outcomes. Now, these factors, among others, have to be assessed on a higher level of evidence. This would be, to date, the first randomized controlled trial comparing clinical patient reported outcomes of robotic guided (RG) pedicle screw placement vs. navigated (NV) vs. free hand (FH) pedicle screw placement.

The investigator's 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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evidence of Robot Guided vs. Navigated vs. Free Hand Lumbar Spinal Fusion
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Robot-guided
Robotic guidance (SpineAssist®or Renaissance® (Mazor Robotics Ltd. Caesarea, Israel) will be used for navigation and insertion of pedicle screws.
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.
Active Comparator: Navigated
A computer-assisted method of navigation (CT- or 3D-Fluoroscopy-based) will be used for navigation and insertion of pedicle screws.
Procedure: Pedicle Screw Placement
As a part of the lumbar spinal fusion procedure, posterior pedicle screws will be placed.
Device: 3D C-Arm (Ziehm Imaging, Nuremberg, Germany)
This 3D Fluoroscope will be used to navigate pedicle screws into their trajectories.
Active Comparator: Freehand
Pedicle screws will be inserted using the freehand technique under fluoroscopic control.
Procedure: Pedicle Screw Placement
As a part of the lumbar spinal fusion procedure, posterior pedicle screws will be placed.



Primary Outcome Measures :
  1. Quality of Life after Spinal Fusion as assessed using the Euroqol EQ-5D questionnaire [ Time Frame: 12 months after surgery ]
  2. Back Pain after Spinal Fusion as assessed using the Oswestry Disability Index (ODI) [ Time Frame: 12 months after surgery ]
  3. Back and Leg pain after Spinal Fusion as assessed using a Virtual Analogue Scale (VAS) [ Time Frame: 12 months after surgery ]

Secondary Outcome Measures :
  1. Number of Pedicle Screws that needed intraoperative Revision [ Time Frame: Intraoperatively (From induction until end of anesthesia) ]
    If a pedicle screw is malpositioned and this is noticed intraoperatively, the screw can be removed and revised.

  2. Number of Revision Surgeries for malpositioned Screws [ Time Frame: Through study completion, an average of 12 months ]
    If a screw malposition is not detected intraoperatively and neurological deficits or other complaints secondary to the malpositioned screw arise, the screw needs to be surgically revised.



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Ages Eligible for Study:   17 Years to 79 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent
  • Lumbar single level discopathy or Spondylolisthesis of Meyerding Grade 1 or 2
  • Body Mass Index >19 and <33
  • American Society of Anesthesiologists Scale 1 or 2

Exclusion Criteria:

  • Severe Scoliosis (Coronal Cobb's >30 degrees / Schwab classification sagittal modifier + or ++)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998060


Contacts
Contact: Marc L Schröder, MD, PhD +31 88 9000500 m.schroder@bergmanclinics.nl
Contact: Victor E Staartjes, Stud. Med. +31 88 9000500 victoregon.staartjes@uzh.ch

Locations
Germany
Universitätsmedizin Göttingen Georg-August Not yet recruiting
Gottingen, Niedersachsen, Germany, 37075
Contact: Bawarjan Schatlo, MD    +49 551 39 6737    bawarjan.schatlo@med.uni-goettingen.de   
Switzerland
University Hospital Geneva Not yet recruiting
Geneva, Switzerland, 1205
Contact: Enrico Tessitore, MD    +41223728203    enrico.tessitore@hcuge.ch   
Sponsors and Collaborators
Marc Schröder
Investigators
Principal Investigator: Victor E Staartjes, Stud. Med. University of Zurich

Responsible Party: Marc Schröder, MD, PhD, Bergman Clinics
ClinicalTrials.gov Identifier: NCT02998060     History of Changes
Other Study ID Numbers: ABR-59636
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marc Schröder, Bergman Clinics:
Robot
Spinal Fusion
Spine
Navigation
Freehand

Additional relevant MeSH terms:
Spondylolisthesis
Intervertebral Disc Degeneration
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases