Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis
- Conditions
- Scoliosis
- Registration Number
- NCT02084264
- Lead Sponsor
- Mazor Robotics
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 272
- 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
- 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.
- Pregnancy
- Patient cannot follow study protocol, for any reason
- Patient cannot or will not sign informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Revision surgeries 1 year post-surgery All cause revisions, including medical and surgical complications.
- Secondary Outcome Measures
Name Time Method Pedicle screw instrumentation accuracy Within 1 year of surgery, if indicated by surgeon and clinically necessary 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.
Ratio of executed vs. planned screws Day of surgery Number of screws planned to be robotically inserted and manually inserted instead, and cause.
Surgical complications Within first year from day of surgery Implant-related durotomy, infection requiring surgery, excessive blood loss, air emboli, new neural deficits, implant failure
Clinical performance of instrumentation technique Day of surgery instrumentation time per screw, total surgery time, excluding: exposure and closure time, Surgeon-specific surgical techniques that impact surgery time
Improvement of radiographic and health-related quality of life metrics up to 10 years post-operative post-operative radiographs and SRS22 questionnaire
Length of convalescence within 2 years of surgery Length of hospital stay, destination at discharge, time to return to normal activities
Radiation Exposure Day of surgery Reading of exposure in seconds (and KvP, if available) from C-arm or other imaging system used in the operating room.
Hypoplastic pedicles Day of surgery \<4 mm in diameter
Neuromonitoring events Day of surgery Clinical Outcomes as measured on plain radiographs 2 years Curvature correction and shoulder balance
Trial Locations
- Locations (4)
Geisinger Orthopaedic Institute
🇺🇸Danville, Pennsylvania, United States
Children's Healtchare of Atlanta at Scottish Rite
🇺🇸Atlanta, Georgia, United States
Rady Children's Hospital- San Diego
🇺🇸San Diego, California, United States
Florida Hospital for Children
🇺🇸Orlando, Florida, United States