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Administrative
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Robotic-guided, open approach | Robotic-guided, open approach | ||
| Arm 2: control arm- non-robotic, open approach | control arm- non-robotic, open approach° |
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| Measure | Description | Time Frame |
|---|---|---|
| Revision surgeries | All cause revisions, including medical and surgical complications. | 1 year post-surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric/adolescent patients (age 21 years and younger) undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
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| Name | Affiliation | Role |
|---|---|---|
| Doron Dinstein, MD | Mazor Robotics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital- San Diego | San Diego | California | 92123 | United States | ||
| Florida Hospital for Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21079498 | Background | Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab. |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |
| Orlando |
| Florida |
| 32801 |
| United States |
| Children's Healtchare of Atlanta at Scottish Rite | Atlanta | Georgia | 30342 | United States |
| Geisinger Orthopaedic Institute | Danville | Pennsylvania | 17822 | United States |