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To quantify potential short- and long-term benefits of robotically-guided minimally invasive (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed using a freehand technique, both in MIS and open approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Robotic-guided, Open approach | Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. | ||
| Arm 2: control-arm - non-robotic, open approach | Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. | ||
| Arm 3: robotic-guided, MIS approach | Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. | ||
| Arm 4: control-arm - freehand, MIS approach | Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of surgical complications | New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss | 1 year |
| Intraoperative radiation exposure | as measured by the C-arm, normalized per screw | Day of operation |
| Revision surgeries | All cause revisions, including medical and surgical complications. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Deformity correction as measured on plain radiographs | Parameters of sagittal and coronal balance | Within 2 years from surgery |
| Clinical outcome measures assessed using health-related quality of life questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (age over 21 years) undergoing long (5 or more consecutive vertebrae) open or minimally invasive instrumentation, correction and fusion sugery in the thoracic, lumbar or sacral spine who have been found to have kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.
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| Name | Affiliation | Role |
|---|---|---|
| Doron Dinstein, MD | Mazor Robotics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23584231 | Background | Hu X, Ohnmeiss DD, Lieberman IH. Use of an ultrasonic osteotome device in spine surgery: experience from the first 128 patients. Eur Spine J. 2013 Dec;22(12):2845-9. doi: 10.1007/s00586-013-2780-y. Epub 2013 Apr 16. | |
| 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 |
| D007738 | Kyphosis |
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Visual Analog Scale (VAS) back and leg, Oswestry Disability Index (ODI), SRS22 questionnaire, European Quality - 5 dimensions (EQ-5D-5L)
| up to 10 years post-operative |
| 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 |
| Length of convalescence | Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work | Within 2 years of surgery |
| Ratio of executed vs. planned screws | Number of screws planned to be robotically inserted but manually inserted instead, and cause. | Day of surgery |
| Times of intra-operative stages | Instrumentation time per screw, total surgery time | Day of surgery |
| Implant Failure | The implant failure rate as measured within one year post-surgery | Within 1 year post-surgery |
| Number of Abandoned Screws | Number of screws intended to be instrumented with the robot and abandoned for cause. | Day of surgery |
| Number of screws instrumented freehand | Number of screws planned to be instrumented robotically and instrumented freehand instead. | Day of surgery |
| Clinical performance of instrumentation technique | Implant instrumentation time, length of surgery | Day of surgery |
| Fusion rate/pseudoarthrosis | Fusion/pseudoarthrosis as measured within one year of surgery | Within one year post-surgery |
| Neuromonitoring events | The number of clinically significant neuromonitoring events that may or may not lead to removal or reinstrumentation of the pedicle screw. | Day of surgery |