Scoliosis
Conditions
Keywords
Adolescent Idiopathic Scoliosis, Pediatric Scoliosis
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
Interventions
None listed
Sponsors
Mazor Robotics
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision surgeries | 1 year post-surgery | All cause revisions, including medical and surgical complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuromonitoring events | Day of surgery | — |
| Hypoplastic pedicles | Day of surgery | \<4 mm in diameter |
| 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 |
| 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 |
| 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. |
| Ratio of executed vs. planned screws | Day of surgery | Number of screws planned to be robotically inserted and manually inserted instead, and cause. |
| 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. |
| 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 Outcomes as measured on plain radiographs | 2 years | Curvature correction and shoulder balance |
Countries
United States
Outcome results
None listed