MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries Surgeries

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Mazor Robotics
Sponsor:
Information provided by (Responsible Party):
Mazor Robotics
ClinicalTrials.gov Identifier:
NCT02057744
First received: February 5, 2014
Last updated: July 27, 2014
Last verified: July 2014
  Purpose

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
Degenerative Disc Disease
Spinal Stenosis
Spondylolisthesis
Spondylosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mazor Robotics:

Primary Outcome Measures:
  • Intra-operative exposure to x-ray radiation [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room.

  • Surgical complications [ Time Frame: Within first year from day of surgery ] [ Designated as safety issue: No ]
    New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse

  • Revision surgeries [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    All cause revisions


Secondary Outcome Measures:
  • Pedicle screw instrumentation accuracy [ Time Frame: Within 1 year of surgery, if indicated by surgeon and clinically necessary ] [ Designated as safety issue: No ]
    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.

  • Incidence of pseudoarthrosis (malunion) [ Time Frame: Within 10 years from surgery ] [ Designated as safety issue: No ]
    Failure of the operated spinal segment to fuse.

  • Length of convalescence [ Time Frame: Within 2 years of surgery ] [ Designated as safety issue: No ]
    Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work

  • Times of intra-operative stages [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    instrumentation time per screw, total surgery time

  • Ratio of executed vs. planned screws [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    number of screws planned to be robotically inserted and manually inserted instead and cause.

  • Quality of life assessment [ Time Frame: Each visit up to 10 years ] [ Designated as safety issue: No ]
    Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L)


Estimated Enrollment: 2000
Study Start Date: August 2014
Estimated Study Completion Date: January 2027
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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. Include surgeries involving iliac screws, although these screws will not be included in the data analysis.
  3. Primary surgery
  4. Patient capable of complying with study requirements
  5. Signed informed consent by patient

Exclusion Criteria:

  1. Pregnancy
  2. Revision surgery
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057744

Contacts
Contact: Doron Dinstein, MD (800) 80 - MAZOR clinicalstudy@mazorrobotics.com

Locations
United States, Florida
Florida Hospital Celebration Health Not yet recruiting
Celebration, Florida, United States
Contact: Faissal Zahrawi, MD    407-764-4270    SPINESRG@AOL.COM   
Principal Investigator: Faissal Zahrawi, MD         
Baptist Health Not yet recruiting
Jacksonville, Florida, United States
Contact: Barbara P Hurlbert    904-388-6518    bhurlbert@lyerlyneuro.com   
Principal Investigator: Andrew F Cannestra, MD, PhD         
United States, Virginia
Virginia Spine Institute Not yet recruiting
Reston, Virginia, United States
Contact: Anne Copay, PhD    703-709-1114 ext 144    acopay@spinerf.org   
Principal Investigator: Christopher R Good, MD         
India
Apollo Hospitals Not yet recruiting
Chennai, Tamil Nadu, India
Contact: Vamsi K Varma, MD    +91 44 2829 0200    enquiry@apollohospitals.com   
Principal Investigator: Sajan K Hegde, MD         
Sponsors and Collaborators
Mazor Robotics
Investigators
Study Director: Doron Dinstein, MD Mazor Robotics, Ltd
  More Information

Publications:
Responsible Party: Mazor Robotics
ClinicalTrials.gov Identifier: NCT02057744     History of Changes
Other Study ID Numbers: CLN110
Study First Received: February 5, 2014
Last Updated: July 27, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Spinal Stenosis
Spondylolisthesis
Spondylosis
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis

ClinicalTrials.gov processed this record on July 31, 2014