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
NA
200 participants
INTERVENTIONAL
2019-12-18
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Robotic
Patients receiving spine surgery with posterior stabilization placed by ExcelsiusGPS
ExcelsiusGPS™
The ExcelsiusGPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (pre-operative CT, intra-operative CT and fluoroscopy), using a dynamic reference base and positioning camera.
Interventions
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ExcelsiusGPS™
The ExcelsiusGPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (pre-operative CT, intra-operative CT and fluoroscopy), using a dynamic reference base and positioning camera.
Eligibility Criteria
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Inclusion Criteria
* Require surgery that includes posterior stabilization with screws to be inserted in cervical, thoracic, lumbar spine or sacrum
* Able to sign Informed Consent
Exclusion Criteria
* DEXA score of -2.5 or below (only if clinically indicated - optional)
* Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
* History of substance abuse (drugs or alcohol)
* Mentally incompetent or prisoner
* Worker's compensation
* Pregnant or intention to become pregnant
18 Years
85 Years
ALL
No
Sponsors
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Globus Medical Inc
INDUSTRY
Responsible Party
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Locations
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Southeastern Spine Institute
Mt. Pleasant, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RGC18-002
Identifier Type: -
Identifier Source: org_study_id