Advanced SPinal Innovations With Robotics and Enabling Technology Registry

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 frame: 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.).

Time frame: 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.).

Time frame: 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.).

Time frame: 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."

Time frame: 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)."

Time frame: 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)."

Time frame: 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."

Time frame: 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."

Time frame: 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."

Time frame: 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 frame: Time of surgery

Estimated blood loss (EBL)

EBL during surgery will be reported by the surgeon or extracted from surgical documentation.

Time frame: 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 frame: Time of surgery

Improvement to spinopelvic alignment with PSR

Spinopelvic alignment parameters including pelvic tilt, pelvic incidence, lumbar lordosis, thoracic kyphosis and sagittal vertical axis

Time frame: Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years