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Sponsor Decision
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To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.
The key objective of this observational registry is to prospectively collect data to facilitate the quantification of potential short- and long-term benefits of Renaissance-guided spine surgery. It establishes a common framework for collaboration between surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or open surgical approaches.
The main endpoints that will be collected are surgical endpoints (e.g. complication rates), patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal alignment, mainly in reconstructive surgeries for spinal deformities) and technical parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes as measured on plain radiographs | sagittal and coronal alignment in reconstructive surgeries for spinal deformities | Within 10 years of surgery |
| Surgical complications | new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss | Within 10 years of surgery |
| Reoperation rates | Any revision surgery on the segment of interest | Within 10 years of surgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance of instrumentation technique | implant instrumentation time, total surgery time | Day of surgery |
| Ratio of executed vs. planned screws | Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause |
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Inclusion Criteria:
Patients undergoing spinal surgery in a posterior approach where the surgeon used Renaissance surgical guidance system.
Patient capable of complying with study requirements. Signed informed consent by patient.
Exclusion Criteria:
Any significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study.
Patient cannot follow study protocol, for any reason. Patient cannot or will not sign informed consent.
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Any pediatric, adolescent or adult patient undergoing open or MIS Renaissance-guided spine surgery
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| Name | Affiliation | Role |
|---|---|---|
| Doron Dinstein, MD, MBA | Mazor Robotics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyerly Baptist/ Lyerly Neurosurgery | Jacksonville | Florida | 32207 | United States | ||
| Tabor Orthopedics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21602728 | Background | Lieberman IH, Hardenbrook MA, Wang JC, Guyer RD. Assessment of pedicle screw placement accuracy, procedure time, and radiation exposure using a miniature robotic guidance system. J Spinal Disord Tech. 2012 Jul;25(5):241-8. doi: 10.1097/BSD.0b013e318218a5ef. | |
| 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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| Day of surgery |
| Number of abandoned screws | the number of screws not instrumented and the reason | Day of surgery |
| Neuromonitoring events | Day of surgery |
| Length of convalescence | Length of hospital stay, destination at discharge, time to return to work, time to return to normal activities | within 2 years of surgery |
| Improvement in health-related quality of life metrics | back and leg VAS, Oswestry Disability Index (ODI), SRS22, EQ-5D-5L, in accordance with the surgeon's practices | up to 10 years post-operative |
| Fusion rates/pseudoarthrosis | The rate of fusion as determined within one year of surgical procedure. | Within 1 year of surgery |
| Implant placement accuracy | Accuracy of implants as measured on a post-operative CT scan (when available) | Within one year post-surgery |
| Memphis |
| Tennessee |
| 38119 |
| United States |
| Spine Associates | Houston | Texas | 77063 | United States |
| The Virginia Spine Institute | Reston | Virginia | 20190 | United States |
| 21384205 | 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. |
| 17268254 | Background | Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine (Phila Pa 1976). 2007 Feb 1;32(3):E111-20. doi: 10.1097/01.brs.0000254048.79024.8b. |
| 17224800 | Background | Rajasekaran S, Vidyadhara S, Ramesh P, Shetty AP. Randomized clinical study to compare the accuracy of navigated and non-navigated thoracic pedicle screws in deformity correction surgeries. Spine (Phila Pa 1976). 2007 Jan 15;32(2):E56-64. doi: 10.1097/01.brs.0000252094.64857.ab. |
| 20862593 | Background | Tian NF, Huang QS, Zhou P, Zhou Y, Wu RK, Lou Y, Xu HZ. Pedicle screw insertion accuracy with different assisted methods: a systematic review and meta-analysis of comparative studies. Eur Spine J. 2011 Jun;20(6):846-59. doi: 10.1007/s00586-010-1577-5. Epub 2010 Sep 23. |
| 21217448 | Background | Hamilton DK, Smith JS, Sansur CA, Glassman SD, Ames CP, Berven SH, Polly DW Jr, Perra JH, Knapp DR, Boachie-Adjei O, McCarthy RE, Shaffrey CI; Scoliosis Research Society Morbidity and Mortality Committee. Rates of new neurological deficit associated with spine surgery based on 108,419 procedures: a report of the scoliosis research society morbidity and mortality committee. Spine (Phila Pa 1976). 2011 Jul 1;36(15):1218-28. doi: 10.1097/BRS.0b013e3181ec5fd9. |