Spine Procedures Assisted With RoboTics And Navigation

Study Overview
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Brief Summary
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Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.

Official Title
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Spine Procedures Assisted With RoboTics And Navigation Registry

Conditions
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Spine Deformity, Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Spondylolisthesis, Congenital Scoliosis, Neuromuscular Scoliosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of a spine deformity Scheduled for surgery using robotics and navigation Up to and including 21 years of age Speak and read English or Spanish Exclusion Criteria: • None

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Spine Deformity Patients<br>Standard of care surgery using robotics coupled with navigation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of pedicle screws within 2 mm of cortical breach | The proportion of pedicle screws within 2 mm of cortical breach when assessed on intraoperative O-arm scans and postoperative CT scans (when applicable). | Time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiation dose to patient and surgeon per screw | Radiation dose to patient and surgeon per screw based on the following imaging studies when performed: preoperative CT scan, intraoperative O-arm scans, and fluoroscopy. | Time of surgery | 
| Scoliosis Research Society (SRS-30) Questionnaire | Questionnaires will be completed by both the patient and caregiver based on their appropriate diagnosis (i.e. idiopathic, congenital, spondylolisthesis, etc.). | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | 
| Early Onset Scoliosis 24-Item Questionnaire (EOSQ-24) | Questionnaires will be completed by both the patient and caregiver based on their appropriate diagnosis (i.e. idiopathic, congenital, spondylolisthesis, etc.). | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | 
| Caregiver Priorities & Child Health Index of Life with Disabilities (CP Child) | Questionnaires will be completed by both the patient and caregiver based on their appropriate diagnosis (i.e. idiopathic, congenital, spondylolisthesis, etc.). | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity | Self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living. | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety | Fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depressive Symptoms | Negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Mobility | Activities of physical mobility such as getting out of bed or a chair to activities such as running. | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain - Interference | Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships | Quality of relationships with friends and other acquaintances. | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | 
| Operative time | Data collection on time related to robotics-navigation, including registration, screw planning, screw placement, and total time related to platform use defined as the beginning of registration to last screw placement. | Time of surgery | 
| Estimated blood loss (EBL) | EBL during surgery will be reported by the surgeon or extracted from surgical documentation. | Time of surgery | 
| Total operative cost | Capital expenses associated with the equipment and software, preoperative planning time, surgical time, and costs for revision surgery caused by screw malposition. | Time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Spine, Surgery, Registry, Robotic, Navigation