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MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries

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ClinicalTrials.gov Identifier: NCT02057744
Recruitment Status : Recruiting
First Posted : February 7, 2014
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mazor Robotics

Brief Summary:
To quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.

Condition or disease
Degenerative Spine Disease Spondylolisthesis Spondylosis

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
Study Start Date : October 2014
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : March 2032

Group/Cohort
Robotic-guided
Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive robotic-guided spinal fixation surgery.
Freehand image-guided
Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive image-guided freehand or navigated spinal fixation surgery.



Primary Outcome Measures :
  1. Intra-operative exposure to x-ray radiation [ 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.

  2. Surgical complications [ Time Frame: Within first year from day of surgery ]
    New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse

  3. Revision surgeries [ Time Frame: 2 years ]
    All cause revisions


Secondary Outcome Measures :
  1. 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 postoperative CTs that are clinically necessary for the management of the patient.

  2. Incidence of pseudoarthrosis (malunion) [ Time Frame: Within 10 years from surgery ]
    Failure of the operated spinal segment to fuse.

  3. 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

  4. Times of intra-operative stages [ Time Frame: Day of surgery ]
    instrumentation time per screw, total surgery time

  5. 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.

  6. Quality of life assessment [ Time Frame: Each visit up to 10 years ]
    Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L)



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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive spinal fixation sugery.
Criteria

Inclusion Criteria:

  1. Adult patients (age over 21 years), undergoing short (4 or less consecutive vertebrae) lumbar or lumbosacral percutaneous/MIS spinal fixation surgery.
  2. May include surgeries involving iliac screws, although these screws will not be included in the data analysis.
  3. Primary fusion surgery
  4. Patient capable of complying with study requirements
  5. Signed informed consent by patient

Exclusion Criteria:

  1. Pregnancy
  2. Revision surgery (prior laminectomy or discectomy is not excluded).
  3. Infection or malignancy
  4. Primary abnormalities of bones (e.g. osteogenesis imperfecta)
  5. Primary muscle diseases, such as muscular dystrophy
  6. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma)
  7. Spinal cord abnormalities with any neurologic symptoms or signs
  8. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
  9. Paraplegia
  10. Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
  11. Patients requiring anterior release or instrumentation
  12. 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.
  13. Patient cannot follow study protocol, for any reason
  14. Patient cannot or will not sign informed consent

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): NCT02057744


Contacts
Contact: Doron Dinstein, MD (800) 80 - MAZOR clinicalstudy@mazorrobotics.com
Contact: Sara L Rivera, BS, CCRA 3212460223 s.rivera@mazorrobotics-us.com

Locations
United States, Florida
Florida Hospital Celebration Health Active, not recruiting
Celebration, Florida, United States, 34747
Baptist Health Recruiting
Jacksonville, Florida, United States
Contact: Karen Bell, BSH    904-202-7998    karen.bell2@bmcjax.com   
Contact: Nancy Ebreo    904.716.3668    Nancy.Ebreo@bmcjax.com   
Principal Investigator: Andrew F Cannestra, MD, PhD         
University of Miami Active, not recruiting
Miami, Florida, United States, 33136
Central Florida Neurosurgery Institute Active, not recruiting
Orlando, Florida, United States, 32801
Southeastern Spine Center & Research Institute Active, not recruiting
Sarasota, Florida, United States, 34232
United States, Michigan
Michigan Orthopaedic Spine Surgeons Terminated
Rochester Hills, Michigan, United States, 48307
United States, Pennsylvania
The Rothman Institute Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Liz James    215-454-2247    liz.james@rothmaninstitute.com   
Principal Investigator: Victor Hsu, MD         
United States, Tennessee
Tabor Orthopedics Active, not recruiting
Memphis, Tennessee, United States, 38116
United States, Virginia
Atlantic Brain & Spine Active, not recruiting
Fairfax, Virginia, United States, 22031
Virginia Spine Institute Active, not recruiting
Reston, Virginia, United States, 20191
Sponsors and Collaborators
Mazor Robotics
Investigators
Study Director: Doron Dinstein, MD Mazor Robotics, Ltd

Publications:
Responsible Party: Mazor Robotics
ClinicalTrials.gov Identifier: NCT02057744     History of Changes
Other Study ID Numbers: CLN110
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

Keywords provided by Mazor Robotics:
Robotic-guided surgery
Minimally invasive spinal surgery
Spinal fusion
Pedicle screws

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