Multicenter, Prospective, Partially Randomized, Controlled Trial of Robotic-guided vs. Freehand Corrective Surgery for Pediatric Scoliosis

Mazor Robotics4 sites in 1 country272 target enrollmentOctober 2014

ConditionsScoliosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Scoliosis
Sponsor: Mazor Robotics
Enrollment: 272
Locations: 4
Primary Endpoint: Revision surgeries
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

July 8, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mazor Robotics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pediatric/adolescent patients (age 10 to 21 years), undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
•Patient capable of complying with study requirements
•Signed informed consent by patient

Exclusion Criteria

•Scheuermann's disease
•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 post-surgery

All cause revisions, including medical and surgical complications.

Secondary Outcomes

Clinical Outcomes as measured on plain radiographs(2 years)
Ratio of executed vs. planned screws(Day of surgery)
Surgical complications(Within first year from day of surgery)
Pedicle screw instrumentation accuracy(Within 1 year of surgery, if indicated by surgeon and clinically necessary)
Clinical performance of instrumentation technique(Day of surgery)
Improvement of radiographic and health-related quality of life metrics(up to 10 years post-operative)
Length of convalescence(within 2 years of surgery)
Radiation Exposure(Day of surgery)
Hypoplastic pedicles(Day of surgery)
Neuromonitoring events(Day of surgery)