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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Recruitment Status : Withdrawn (Change in study design [Randomization not feasible])
First Posted : December 20, 2016
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Marc Schröder, Bergman Clinics

Tracking Information
First Submitted Date  ICMJE December 11, 2016
First Posted Date  ICMJE December 20, 2016
Last Update Posted Date October 22, 2018
Estimated Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • Quality of Life after Spinal Fusion as assessed using the Euroqol EQ-5D questionnaire [ Time Frame: 12 months after surgery ]
  • Back Pain after Spinal Fusion as assessed using the Oswestry Disability Index (ODI) [ Time Frame: 12 months after surgery ]
  • Back and Leg pain after Spinal Fusion as assessed using a Virtual Analogue Scale (VAS) [ Time Frame: 12 months after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02998060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evidence of Robot Guided vs. Navigated vs. Free Hand Lumbar Spinal Fusion
Official Title  ICMJE Clinical Evidence of Robot Guided vs. Navigated vs. Free Hand Lumbar Spinal Fusion
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spondylolisthesis
  • Intervertebral Disc Degeneration
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Robot-guided
    Robotic guidance (SpineAssist®or Renaissance® (Mazor Robotics Ltd. Caesarea, Israel) will be used for navigation and insertion of pedicle screws.
    Interventions:
    • Procedure: Pedicle Screw Placement
    • Device: SpineAssist®/Renaissance® (Mazor Robotics Ltd. Caesarea, Israel)
  • Active Comparator: Navigated
    A computer-assisted method of navigation (CT- or 3D-Fluoroscopy-based) will be used for navigation and insertion of pedicle screws.
    Interventions:
    • Procedure: Pedicle Screw Placement
    • Device: 3D C-Arm (Ziehm Imaging, Nuremberg, Germany)
  • Active Comparator: Freehand
    Pedicle screws will be inserted using the freehand technique under fluoroscopic control.
    Intervention: Procedure: Pedicle Screw Placement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 18, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2016)
115
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ++)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 79 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02998060
Other Study ID Numbers  ICMJE ABR-59636
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marc Schröder, Bergman Clinics
Study Sponsor  ICMJE Marc Schröder
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Victor E Staartjes, Stud. Med. University of Zurich
PRS Account Bergman Clinics
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP