MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries

Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries

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.

Study Overview

• Status: Unknown
• Conditions: Spondylosis; Spondylolisthesis; Degenerative Spine Disease

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• United States
  • Florida
    • Celebration, Florida, United States, 34747
      • Florida Hospital Celebration Health
    • Jacksonville, Florida, United States
      • Baptist Health
    • Miami, Florida, United States, 33136
      • University of Miami
    • Orlando, Florida, United States, 32801
      • Central Florida Neurosurgery Institute
    • Sarasota, Florida, United States, 34232
      • Southeastern Spine Center & Research Institute
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • The Rothman Institute
  • Tennessee
    • Memphis, Tennessee, United States, 38116
      • Tabor Orthopedics
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Atlantic Brain & Spine
    • Reston, Virginia, United States, 20191
      • Virginia Spine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative exposure to x-ray radiation	Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room.	Day of surgery
Surgical complications	New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse	Within first year from day of surgery
Revision surgeries	All cause revisions	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pedicle screw instrumentation accuracy	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.	Within 1 year of surgery, if indicated by surgeon and clinically necessary
Incidence of pseudoarthrosis (malunion)	Failure of the operated spinal segment to fuse.	Within 1 year from surgery
Length of convalescence	Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work	Within 1 year of surgery
Times of intra-operative stages	instrumentation time per screw, total surgery time	Day of surgery
Ratio of executed vs. planned screws	number of screws planned to be robotically inserted and manually inserted instead and cause.	Day of surgery
Quality of life assessment	Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L)	Each visit up to 1 year1

Collaborators and Investigators

• Sponsor: Mazor Robotics
• Investigators: Study Director: Doron Dinstein, MD, Mazor Robotics, Ltd

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: February 5, 2014
• First Posted (Estimate): February 7, 2014

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Spinal fusion; Pedicle screws; Robotic-guided surgery; Minimally invasive spinal surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spondylolysis; Spinal Diseases; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: CLN110