Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis

Study Overview
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Brief Summary
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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

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

Conditions
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Scoliosis

Participation Criteria
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Eligibility Criteria
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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. Pregnancy Patient cannot follow study protocol, for any reason Patient cannot or will not sign informed consent

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1: Robotic-guided, open approach<br>Robotic-guided, open approach | |
| Arm 2: control arm- non-robotic, open approach<br>control arm- non-robotic, open approach° | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision surgeries | All cause revisions, including medical and surgical complications. | 1 year post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day of surgery | 
| Neuromonitoring events |  | Day of surgery | 
| Hypoplastic pedicles | <4 mm in diameter | Day of surgery | 
| Improvement of radiographic and health-related quality of life metrics | post-operative radiographs and SRS22 questionnaire | up to 10 years post-operative | 
| Length of convalescence | Length of hospital stay, destination at discharge, time to return to normal activities | within 2 years of surgery | 
| Clinical Outcomes as measured on plain radiographs | Curvature correction and shoulder balance | 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. | Day of surgery | 
| Ratio of executed vs. planned screws | Number of screws planned to be robotically inserted and manually inserted instead, and cause. | 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. | 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 | Within first year from day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Scoliosis, Adolescent Idiopathic Scoliosis