Prospective Robotic-Guided Registry of Spine Surgery

Study Overview
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Brief Summary
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This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.

Detailed Description
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What is the impact on clinical and patient-reported outcomes for participants who undergo robot assisted surgery? This will be the first multi-center study to prospectively collect data on robotic assisted spine surgery outcomes. The primary objective of this study will be to facilitate quantification of potential short- and long-term benefits of robotically guided spine surgeries. It is hypothesized that use of robotic guidance during spinal instrumentation will have numerous short- and long-term benefits to both participant and surgeon. Expected benefits include improved surgical and clinical outcomes, lower incidence of procedure-related adverse events (e.g., fewer new neurological deficits, implant-related durotomies, and implant misplacements), improved implant accuracy, lower intraoperative radiation exposure, and lower reoperation rates, when compared to the published literature. The secondary objective of this study is to assess the clinical performance of robotic instrumentation as per the pre-operative plan. To this end, data on a number of common clinical metrics will be analyzed to determine the extent to which they are affected by the use of robotic guidance during implantation.

Official Title
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Prospective Robotic-Guided Registry of Spine Surgery

Conditions
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Spinal Disease

Intervention / Treatment
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* Procedure: Robotic-guided spine surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any pediatric, adolescent or adult patient Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology. Exclusion Criteria: Pregnancy active infection malignancy primary abnormalities of bone primary muscle diseases (e.g., muscular dystrophy) neurologic diseases spinal cord abnormalities/lesions paraplegia.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic-guided surgery group<br>Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80. | Procedure: Robotic-guided spine surgery<br>* The Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the success of robotic-guided spine surgery, from planning to execution. | To evaluate the success from planning to execution of robotic screw placement. | 1 year after surgery | 
| To evaluate the success of robotic-guided spine surgery, by screw placement accuracy. | To determine screw accuracy | 1 year after surgery | 
| To evaluate the success of robotic-guided spine surgery, by revision surgery rates. | To determine the rate of revision surgery due to symptomatic screw malposition within 1 year | 1 year after surgery | 
| To evaluate the success of robotic-guided spine surgery, by the radiation exposure. | To determine radiation exposure to the patient and surgeon. | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate clinical outcomes, as determined by all cause revisions | To determine the rate of revision surgery for all causes within 1 year | 1 year after surgery | 
| To evaluate clinical outcomes, by surgical complications | To determine the rate of surgical complications (wound infection/dehiscence, major neurological deficit, hemorrhage, dural tear) | 1 year after surgery | 
| To evaluate clinical outcomes, by patient reported outcome measures | To evaluate for changes in Patient Reported Outcomes Measurement Information System (PROMIS) scores over 1 year; (PROMIS scores are calculated at T-scores on a 0-100 point scale - for positively worded functions, such as physical function and global health, the higher the score the better the outcome; but for negatively worded functions, like pain interference, the higher the score the worse the outcome). | 1 year after surgery | 
| To evaluate clinical outcomes, by patient disability rating | To evaluate for changes in Oswestry Disability Index (ODI) scores over 1 year; disability scores range from 0-100, the higher the score the worse the outcome/disability. | 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic-guided spine surgery