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To quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-guided | Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive robotic-guided spinal fixation surgery. | ||
| Freehand image-guided | Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive image-guided freehand or navigated spinal fixation surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative exposure to x-ray radiation | Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room. | Day of surgery |
| Surgical complications | New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse | Within first year from day of surgery |
| Revision surgeries | All cause revisions | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pedicle screw instrumentation accuracy | Accuracy will be quantified in millimeters and scored using the Gertzbein-Robbins classification, based on postoperative CTs that are clinically necessary for the management of the patient. | Within 1 year of surgery, if indicated by surgeon and clinically necessary |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive spinal fixation sugery.
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| Name | Affiliation | Role |
|---|---|---|
| Doron Dinstein, MD | Mazor Robotics, Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Celebration Health | Celebration | Florida | 34747 | United States | ||
| Baptist Health |
| 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. | |
| 21384205 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 30, 2020 | |
| Reset | Oct 22, 2020 | |
| Release | Jun 27, 2021 | |
| Reset | Jul 15, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 30, 2020 | Oct 22, 2020 | |||
| Jun 27, 2021 |
| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Incidence of pseudoarthrosis (malunion) |
Failure of the operated spinal segment to fuse. |
| Within 1 year from 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 1 year of surgery |
| Times of intra-operative stages | instrumentation time per screw, total surgery time | 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 |
| Quality of life assessment | Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L) | Each visit up to 1 year1 |
| Jacksonville |
| Florida |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Central Florida Neurosurgery Institute | Orlando | Florida | 32801 | United States |
| Southeastern Spine Center & Research Institute | Sarasota | Florida | 34232 | United States |
| The Rothman Institute | Abington | Pennsylvania | 19001 | United States |
| Tabor Orthopedics | Memphis | Tennessee | 38116 | United States |
| Atlantic Brain & Spine | Fairfax | Virginia | 22031 | United States |
| Virginia Spine Institute | Reston | Virginia | 20191 | United States |
| Background |
| Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011 Jun;20(6):860-8. doi: 10.1007/s00586-011-1729-2. Epub 2011 Mar 8. |
| 22975723 | Background | Hu X, Ohnmeiss DD, Lieberman IH. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J. 2013 Mar;22(3):661-6. doi: 10.1007/s00586-012-2499-1. Epub 2012 Sep 14. |
| Jul 15, 2021 |