Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pediatric Orthopaedic Society of North America | OTHER |
| Medtronic | INDUSTRY |
| Children's Hospital Colorado | OTHER |
| Hospital for Special Surgery, New York |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Spine Deformity Patients | Standard of care surgery using robotics coupled with navigation and/or patient-specific rods |
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• None
Not provided
Not provided
Study participants will be those receiving treatment for spinal deformity at one of the participating sites. Eligible patients will be identified from clinical databases of children undergoing surgery for spinal deformity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessie Tonole, BA | Contact | 857-218-3272 | Jessica.Tonole@childrens.harvard.edu | |
| Sara Olenich, MS, CSCS | Contact | Sara.Olenich@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Hedequist, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Not yet recruiting | Los Angeles | California | 90048 | United States |
The data for this study may also be sent to the Pediatric Spine Foundation Study Group (PSSG) and/or the HARMS Study Group in the future. The study data may be stored in PSSG for use in future research studies conducted by the members of PSSG. To help protect participant confidentiality, any data we send to these groups will not include their name or any other identifying information. Data will be tagged with a study ID.
The sharing timeline is dependent on study investigators and will be considered after enrollment closure.
Not provided
Not provided
Not provided
| OTHER |
| Children's Healthcare of Atlanta | OTHER |
| Rainbow Babies and Children's Hospital | OTHER |
| Dell Children's Medical Center of Central Texas | OTHER |
| Medical University of South Carolina Shawn Jenkins Children's Hospital | OTHER |
| St. Luke's Medical Center | OTHER |
| University of Florida | OTHER |
Not provided
Not provided
Not provided
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 |
| Improvement to spinopelvic alignment with PSR | Spinopelvic alignment parameters including pelvic tilt, pelvic incidence, lumbar lordosis, thoracic kyphosis and sagittal vertical axis | Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years |
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30342 | United States |
|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| St. Louis Children's Hospital | Not yet recruiting | St Louis | Missouri | 63110 | United States |
|
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
|
| Rainbow Babies & Children's Hospital | Not yet recruiting | Cleveland | Ohio | 44106 | United States |
|
| St. Luke's University Health Network | Recruiting | Bethlehem | Pennsylvania | 18015 | United States |
|
| Medical University of South Carolina Shawn Jenkins Children's Hospital | Recruiting | Charleston | South Carolina | 29425 | United States |
|
| Dell Children's Medical Center | Recruiting | Austin | Texas | 78723 | United States |
|
| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided