MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries

• ClinicalTrials.gov Identifier: NCT02057744
• Recruitment Status: Unknown
• First Posted: February 7, 2014
• Last Update Posted: August 20, 2019
• Sponsor: Mazor Robotics
• Information provided by (Responsible Party): Mazor Robotics

Tracking Information

• First Submitted Date: February 5, 2014
• First Posted Date: February 7, 2014
• Last Update Posted Date: August 20, 2019
• Study Start Date: October 2014
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 6, 2019)

• 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.
• 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
• Revision surgeries [ Time Frame: 1 year ]
  All cause revisions

Original Primary Outcome Measures (submitted: February 5, 2014)

• 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.
• 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
• 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)

Current Secondary Outcome Measures (submitted: March 6, 2019)

• 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.
• Incidence of pseudoarthrosis (malunion) [ Time Frame: Within 1 year from surgery ]
  Failure of the operated spinal segment to fuse.
• Length of convalescence [ Time Frame: Within 1 year of surgery ]
  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 ]
  instrumentation time per screw, total surgery time
• 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.
• Quality of life assessment [ Time Frame: Each visit up to 1 year1 ]
  Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L)

Original Secondary Outcome Measures (submitted: February 5, 2014)

• Revision surgeries [ Time Frame: Up to 10 years from day of surgery ]
  Revision of operated spinal anatomy, such as for hardware removal.
• 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.
• Incidence of pseudoarthrosis (malunion) [ Time Frame: Within 10 years from surgery ]
  Failure of the operated spinal segment to fuse.
• 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
• Times intra-operative stages [ Time Frame: Day of surgery ]
  instrumentation time per screw, total surgery time
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
• Official Title: Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Degenerative Spine Disease
• Spondylolisthesis
• Spondylosis

• Intervention: Not Provided

Study 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.

Publications *

• Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab. Erratum In: Spine (Phila Pa 1976). 2011 Jan 1;36(1):91. Gordon, Donald G [corrected to Donald, Gordon D].
• Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011 Jun;20(6):860-8. doi: 10.1007/s00586-011-1729-2. Epub 2011 Mar 8.
• Hu X, Ohnmeiss DD, Lieberman IH. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J. 2013 Mar;22(3):661-6. doi: 10.1007/s00586-012-2499-1. Epub 2012 Sep 14.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 21, 2019): 600
• Original Estimated Enrollment (submitted: February 5, 2014): 2000
• Estimated Study Completion Date: January 2020
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: India

Administrative Information

• NCT Number: NCT02057744
• Other Study ID Numbers: CLN110
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mazor Robotics
• Original Responsible Party: Same as current
• Current Study Sponsor: Mazor Robotics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Doron Dinstein, MD; Mazor Robotics, Ltd

• PRS Account: Mazor Robotics
• Verification Date: August 2019