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
Study Type
OBSERVATIONAL
Enrollment
272
Rady Children's Hospital- San Diego
San Diego, California, United States
Florida Hospital for Children
Orlando, Florida, United States
Children's Healtchare of Atlanta at Scottish Rite
Atlanta, Georgia, United States
Geisinger Orthopaedic Institute
Danville, Pennsylvania, United States
Revision surgeries
All cause revisions, including medical and surgical complications.
Time frame: 1 year post-surgery
Clinical performance of instrumentation technique
instrumentation time per screw, total surgery time, excluding: exposure and closure time, Surgeon-specific surgical techniques that impact surgery time
Time frame: Day of surgery
Neuromonitoring events
Time frame: Day of surgery
Hypoplastic pedicles
\<4 mm in diameter
Time frame: Day of surgery
Improvement of radiographic and health-related quality of life metrics
post-operative radiographs and SRS22 questionnaire
Time frame: up to 10 years post-operative
Length of convalescence
Length of hospital stay, destination at discharge, time to return to normal activities
Time frame: within 2 years of surgery
Clinical Outcomes as measured on plain radiographs
Curvature correction and shoulder balance
Time frame: 2 years
Radiation Exposure
Reading of exposure in seconds (and KvP, if available) from C-arm or other imaging system used in the operating room.
Time frame: Day of surgery
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Ratio of executed vs. planned screws
Number of screws planned to be robotically inserted and manually inserted instead, and cause.
Time frame: Day of surgery
Pedicle screw instrumentation accuracy
Accuracy will be quantified in millimeters and scored using the Gertzbein-Robbins classification, based on post-operative CTs that are clinically necessary for the management of the patient.
Time frame: Within 1 year of surgery, if indicated by surgeon and clinically necessary
Surgical complications
Implant-related durotomy, infection requiring surgery, excessive blood loss, air emboli, new neural deficits, implant failure
Time frame: Within first year from day of surgery