Mini-invasive Spine Surgery for Neuromuscolar Scoliosis
NCT06367933
Neuromuscular Scoliosis, Spine Deformity
Bologna, Italy
View Trial DetailsNCT Number: NCT05071144
Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.
Interested in participating?
Request Info0 year–21 year
All sexes
Observational
Cedars-Sinai Medical Center, Los Angeles, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Time of surgery
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 frame: Time of surgery
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: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
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
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
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
"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
"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
"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
"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
"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
"Quality of relationships with friends and other acquaintances."
Time frame: Time of surgery
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
EBL during surgery will be reported by the surgeon or extracted from surgical documentation.
Time frame: Time of surgery
Capital expenses associated with the equipment and software, preoperative planning time, surgical time, and costs for revision surgery caused by screw malposition.
Time frame: Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years
Spinopelvic alignment parameters including pelvic tilt, pelvic incidence, lumbar lordosis, thoracic kyphosis and sagittal vertical axis
Contact information is provided by the study sponsor or research team.
Jessie Tonole, BA
CONTACT
Sara Olenich, MS, CSCS
CONTACT
Boston Children's Hospital
Other
Acronym: ASPIRE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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