Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2020-11-05
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Robotic-guided surgery group
Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80.
Robotic-guided spine surgery
The Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery.
Interventions
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Robotic-guided spine surgery
The Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery.
Eligibility Criteria
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Inclusion Criteria
* Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology.
Exclusion Criteria
* active infection
* malignancy
* primary abnormalities of bone
* primary muscle diseases (e.g., muscular dystrophy)
* neurologic diseases
* spinal cord abnormalities/lesions
* paraplegia.
12 Years
80 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
The National Spine Health Foundation
OTHER
Responsible Party
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Principal Investigators
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Christopher Good, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Spine Institute
Locations
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National Spine Health Foundation
Reston, Virginia, United States
Countries
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Other Identifiers
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ROB-002
Identifier Type: -
Identifier Source: org_study_id
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