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

Mazor Robotics9 sites in 1 country600 target enrollmentOctober 2014

ConditionsDegenerative Spine Disease Spondylolisthesis Spondylosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Spine Disease
Sponsor: Mazor Robotics
Enrollment: 600
Locations: 9
Primary Endpoint: Revision surgeries
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

January 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mazor Robotics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Revision surgery (prior laminectomy or discectomy is not excluded).
•Infection or malignancy
•Primary abnormalities of bones (e.g. osteogenesis imperfecta)
•Primary muscle diseases, such as muscular dystrophy
•Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma)
•Spinal cord abnormalities with any neurologic symptoms or signs
•Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
•Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
•Patients requiring anterior release or instrumentation
•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.

Outcomes

Primary Outcomes

Revision surgeries

Time Frame: 1 year

All cause revisions

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

Secondary Outcomes

Ratio of executed vs. planned screws(Day of surgery)
Incidence of pseudoarthrosis (malunion)(Within 1 year from surgery)
Length of convalescence(Within 1 year of surgery)
Quality of life assessment(Each visit up to 1 year1)
Pedicle screw instrumentation accuracy(Within 1 year of surgery, if indicated by surgeon and clinically necessary)
Times of intra-operative stages(Day of surgery)