MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries

Spondylolisthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02057744
• Other study ID #: CLN110
• Status: Active, not recruiting
• Start date: October 2014
• Est. completion date: January 2020

Study information

• Verified date: August 2019
• Source: Mazor Robotics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Spine Disease
• Spinal Diseases
• Spondylolisthesis
• Spondylosis

Locations

Country	Name	City	State
United States	The Rothman Institute	Abington	Pennsylvania
United States	Florida Hospital Celebration Health	Celebration	Florida
United States	Atlantic Brain & Spine	Fairfax	Virginia
United States	Baptist Health	Jacksonville	Florida
United States	Tabor Orthopedics	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Central Florida Neurosurgery Institute	Orlando	Florida
United States	Virginia Spine Institute	Reston	Virginia
United States	Southeastern Spine Center & Research Institute	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mazor Robotics

Country where clinical trial is conducted

United States, 

References & Publications (3)

Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stüer 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]. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Revision surgeries	All cause revisions	1 year
Secondary	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
Secondary	Incidence of pseudoarthrosis (malunion)	Failure of the operated spinal segment to fuse.	Within 1 year from surgery
Secondary	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
Secondary	Times of intra-operative stages	instrumentation time per screw, total surgery time	Day of surgery
Secondary	Ratio of executed vs. planned screws	number of screws planned to be robotically inserted and manually inserted instead and cause.	Day of surgery
Secondary	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