Clinical trial NCT02084264: Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis
Official title: Multicenter, Prospective, Partially Randomized, Controlled Trial of Robotic-guided vs. Freehand Corrective Surgery for Pediatric Scoliosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Scoliosis
Keywords: Adolescent Idiopathic Scoliosis
Pediatric Scoliosis
Lead sponsor: Mazor Robotics
Sponsor class: INDUSTRY
First posted: 2014-03-11
Enrollment: 272
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric/adolescent patients (age 21 years and younger) undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Scheuermann's disease
2. Infection or malignancy
3. Primary abnormalities of bones (e.g. osteogenesis imperfecta)
4. Primary muscle diseases, such as muscular dystrophy
5. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
6. Spinal cord abnormalities with any neurologic symptoms or signs
7. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
8. Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
9. Patients requiring anterior release or instrumentation
10. 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.
11. Pregnancy
12. Patient cannot follow study protocol, for any reason
13. Patient cannot or will not sign informed consent

Primary outcomes:
measure: Revision surgeries
timeFrame: 1 year post-surgery
Secondary outcomes:
measure: Clinical performance of instrumentation technique
timeFrame: Day of surgery
measure: Neuromonitoring events
timeFrame: Day of surgery
measure: Hypoplastic pedicles
timeFrame: Day of surgery
measure: Improvement of radiographic and health-related quality of life metrics
timeFrame: up to 10 years post-operative
measure: Length of convalescence
timeFrame: within 2 years of surgery
measure: Clinical Outcomes as measured on plain radiographs
timeFrame: 2 years
measure: Radiation Exposure
timeFrame: Day of surgery
measure: Ratio of executed vs. planned screws
timeFrame: Day of surgery
measure: Pedicle screw instrumentation accuracy
timeFrame: Within 1 year of surgery, if indicated by surgeon and clinically necessary
measure: Surgical complications
timeFrame: Within first year from day of surgery
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital- San Diego
state: California
city: Orlando
country: United States
facility: Florida Hospital for Children
state: Florida
city: Atlanta
country: United States
facility: Children's Healtchare of Atlanta at Scottish Rite
state: Georgia
city: Danville
country: United States
facility: Geisinger Orthopaedic Institute
state: Pennsylvania
Study officials:
affiliation: Mazor Robotics
name: Doron Dinstein, MD
role: STUDY_DIRECTOR
References:
citation: 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.