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ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02058238
First Posted: February 10, 2014
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mazor Robotics
  Purpose
To quantify potential short- and long-term benefits of robotically-guided minimally invasive (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed using a freehand technique, both in MIS and open approaches.

Condition
Scoliosis Kyphosis Kyphoscoliosis Spinal Deformity Spondylosis

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: ADDRESS - Multicenter, Partially-randomized Controlled Trial of Adult Deformity Robotic vs. Freehand Surgery to Correct Adult Spine Deformity

Further study details as provided by Mazor Robotics:

Primary Outcome Measures:
  • Incidence of surgical complications [ Time Frame: 1 year ]
    New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss

  • Intraoperative radiation exposure [ Time Frame: Day of operation ]
    as measured by the C-arm, normalized per screw

  • Revision surgeries [ Time Frame: 2 years ]
    All cause revisions, including medical and surgical complications.


Secondary Outcome Measures:
  • Deformity correction as measured on plain radiographs [ Time Frame: Within 2 years from surgery ]
    Parameters of sagittal and coronal balance

  • Clinical outcome measures assessed using health-related quality of life questionnaires [ Time Frame: up to 10 years post-operative ]
    Visual Analog Scale (VAS) back and leg, Oswestry Disability Index (ODI), SRS22 questionnaire, European Quality - 5 dimensions (EQ-5D-5L)

  • Pedicle screw instrumentation accuracy [ Time Frame: Within 1 year of surgery ]
    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.

  • Length of convalescence [ Time Frame: Within 2 years of surgery ]
    Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work

  • Ratio of executed vs. planned screws [ Time Frame: Day of surgery ]
    Number of screws planned to be robotically inserted but manually inserted instead, and cause.

  • Times of intra-operative stages [ Time Frame: Day of surgery ]
    Instrumentation time per screw, total surgery time

  • Implant Failure [ Time Frame: Within 1 year post-surgery ]
    The implant failure rate as measured within one year post-surgery

  • Number of Abandoned Screws [ Time Frame: Day of surgery ]
    Number of screws intended to be instrumented with the robot and abandoned for cause.

  • Number of screws instrumented freehand [ Time Frame: Day of surgery ]
    Number of screws planned to be instrumented robotically and instrumented freehand instead.

  • Clinical performance of instrumentation technique [ Time Frame: Day of surgery ]
    Implant instrumentation time, length of surgery

  • Fusion rate/pseudoarthrosis [ Time Frame: Within one year post-surgery ]
    Fusion/pseudoarthrosis as measured within one year of surgery

  • Neuromonitoring events [ Time Frame: Day of surgery ]
    The number of clinically significant neuromonitoring events that may or may not lead to removal or reinstrumentation of the pedicle screw.


Estimated Enrollment: 2000
Study Start Date: October 2014
Estimated Study Completion Date: January 2027
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts
Arm 1: Robotic-guided, Open approach
Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.
Arm 2: control-arm - non-robotic, open approach
Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.
Arm 3: robotic-guided, MIS approach
Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.
Arm 4: control-arm - freehand, MIS approach
Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (age over 21 years) undergoing long (5 or more consecutive vertebrae) open or minimally invasive instrumentation, correction and fusion sugery in the thoracic, lumbar or sacral spine who have been found to have kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.
Criteria

Inclusion Criteria:

  1. Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
  2. Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.
  3. Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).
  4. Patient capable of complying with study requirements
  5. Signed informed consent by patient

Exclusion Criteria:

  1. Infection or malignancy
  2. Primary abnormalities of bones (e.g. osteogenesis imperfecta)
  3. Primary muscle diseases, such as muscular dystrophy
  4. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
  5. Spinal cord abnormalities with any neurologic symptoms or signs
  6. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
  7. Paraplegia
  8. Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
  9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
  10. Pregnancy
  11. Patient cannot follow study protocol, for any reason
  12. Patient cannot or will not sign informed consent
  Contacts and Locations
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): NCT02058238


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Mazor Robotics
Investigators
Study Director: Doron Dinstein, MD Mazor Robotics