Clinical Trial: Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Multicenter, Prospective, Partially Randomized, Controlled Trial of Robotic-guided vs. Freehand Corrective Surgery for Pediatric Scoliosis

Brief Summary: To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients

Detailed Summary:
Sponsor: Mazor Robotics

Current Primary Outcome: Revision surgeries [ Time Frame: 1 year post-surgery ]

All cause revisions, including medical and surgical complications.


Original Primary Outcome:

  • Clinical outcomes as measured on plain radiographs [ Time Frame: 2 years ]
    Curvature correction and shoulder balance
  • Radiation exposure [ Time Frame: Day of surgery ]
    Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room.
  • Ratio of executed vs. planned screws [ Time Frame: Day of surgery ]
    number of screws planned to be robotically inserted and manually inserted instead and cause.
  • Pedicle screw instrumentation accuracy [ Time Frame: Within 1 year of surgery, if indicated by surgeon and clinically neccessary ]
    Accuracy will be quantified in millimeters and scored using the Gertzbein-Robbins classification, based on postoperative CTs that are clinically necessary for the management of the patient.
  • Surgical complications [ Time Frame: Within first year from day of surgery ]
    Implant-related durotomy, infection requiring return to surgery, excessive blood loss, air emboli, new neural deficits, implant failure


Current Secondary Outcome:

  • Clinical performance of instrumentation technique [ Time Frame: Day of surgery ]
    instrumentation time per screw, total surgery time, excluding: exposure and closure time, Surgeon-specific surgical techniques that impact surgery time
  • Neuromonitoring events [ Time Frame: Day of surgery ]
  • Hypoplastic pedicles [ Time Frame: Day of surgery ]
    <4 mm in diameter
  • Improvement of radiographic and health-related quality of life metrics [ Time Frame: up to 10 years post-operative ]
    post-operative radiographs and SRS22 questionnaire
  • Length of convalescence [ Time Frame: within 2 years of surgery ]
    Length of hospital stay, destination at discharge, time to return to normal activities
  • Clinical Outcomes as measured on plain radiographs [ Time Frame: 2 years ]
    Curvature correction and shoulder balance
  • Radiation Exposure [ Time Frame: Day of surgery ]
    Reading of exposure in seconds (and KvP, if available) from C-arm or other imaging system used in the operating room.
  • Ratio of executed vs. planned screws [ Time Frame: Day of surgery ]
    Number of screws planned to be robotically inserted and manually inserted instead, and cause.
  • Pedicle screw instrumentation accuracy [ Time Frame: Within 1 year of surgery, if indicated by surgeon and clinically necessary ]
    Accuracy will be quantified in millimeters and scored using the Gertzbein-Robbins classification, based on post-operative CTs that are clinically necessary for the management of the patient.
  • Surgical complications [ Time Frame: Within first year from day of surgery ]
    Implant-related durotomy, infection requiring surgery, excessive blood loss, air emboli, new neural deficits, implant failure


Original Secondary Outcome:

  • Clinical performance of instrumentation technique [ Time Frame: Day of surgery ]
    instrumentation time per screw, total surgery time, excluding: exposure and closure time, Surgeon-specific surgical techniques that impact surgery time
  • Neuromonitoring events [ Time Frame: Day of surgery ]
  • Hypoplastic pedicles [ Time Frame: Day of surgery ]
    <4 mm in diameter
  • Improvement of radiographic and health-related quality of life metrics [ Time Frame: up to 10 years post-operative ]
    post-operative radiographs and SRS22 questionnaire
  • Length of convalescence [ Time Frame: within 2 years of surgery ]
    Length of hospital stay, destination at discharge, time to return to normal activities


Information By: Mazor Robotics

Dates:
Date Received: March 9, 2014
Date Started: October 2014
Date Completion: October 2024
Last Updated: October 13, 2016
Last Verified: October 2016