NCT02998060

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

December 11, 2016

Last Update Submit

October 18, 2018

Conditions

SpondylolisthesisIntervertebral Disc Degeneration

Keywords

RobotSpinal FusionSpineNavigationFreehand

Outcome Measures

Primary Outcomes (3)

  • Quality of Life after Spinal Fusion as assessed using the Euroqol EQ-5D questionnaire

    12 months after surgery

  • Back Pain after Spinal Fusion as assessed using the Oswestry Disability Index (ODI)

    12 months after surgery

  • Back and Leg pain after Spinal Fusion as assessed using a Virtual Analogue Scale (VAS)

    12 months after surgery

Secondary Outcomes (2)

  • Number of Pedicle Screws that needed intraoperative Revision

    Intraoperatively (From induction until end of anesthesia)

  • Number of Revision Surgeries for malpositioned Screws

    Through study completion, an average of 12 months

Study Arms (3)

Robot-guided

ACTIVE COMPARATOR

Robotic guidance (SpineAssist®or Renaissance® (Mazor Robotics Ltd. Caesarea, Israel) will be used for navigation and insertion of pedicle screws.

Procedure: Pedicle Screw PlacementDevice: SpineAssist®/Renaissance® (Mazor Robotics Ltd. Caesarea, Israel)

Navigated

ACTIVE COMPARATOR

A computer-assisted method of navigation (CT- or 3D-Fluoroscopy-based) will be used for navigation and insertion of pedicle screws.

Procedure: Pedicle Screw PlacementDevice: 3D C-Arm (Ziehm Imaging, Nuremberg, Germany)

Freehand

ACTIVE COMPARATOR

Pedicle screws will be inserted using the freehand technique under fluoroscopic control.

Procedure: Pedicle Screw Placement

Interventions

Pedicle Screw PlacementPROCEDURE

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

FreehandNavigatedRobot-guided
SpineAssist®/Renaissance® (Mazor Robotics Ltd. Caesarea, Israel)DEVICE

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

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

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

Navigated

Eligibility Criteria

Age17 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsmedizin Göttingen Georg-August

Göttingen, Lower Saxony, 37075, Germany

Location

University Hospital Geneva

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

SpondylolisthesisIntervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Victor E Staartjes, Stud. Med.

    University of Zurich

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 11, 2016

First Posted

December 20, 2016

Study Start

January 1, 2019

Primary Completion

March 1, 2019

Study Completion

May 1, 2019

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)CH(1)