Clinical Trial of Minimally Invasive Robotic Spine Surgery
NCT ID: NCT02121249
Last Updated: 2020-03-31
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2013-12-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Robot assisted pedicle screw fixation
posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
Renaissance, Mazor Robotics Ltd, Caesare, Israel
Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot
Free hand technique
using Free hand technique, posterior lumbar interbody fusion (No specific device)
free hand technique
No specific device is necessary in the "free hand technique"
Interventions
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Renaissance, Mazor Robotics Ltd, Caesare, Israel
Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot
free hand technique
No specific device is necessary in the "free hand technique"
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary surgery and revision surgery
* Patient capable of complying with study requirements
* Signed informed consent of patient or legal guardian
Exclusion Criteria
* Primary abnormalities of bones (e.g. osteogenesis imperfecta)
* Primary muscle diseases, such as muscular dystrophy
* Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, neurofibroma)
* Spinal cord abnormalities with any neurologic symptoms or signs
* Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
* Paraplegia
* Patients requiring anterior release or instrumentation
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants 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 (or legal guardian, when applicable) cannot or will not sign informed consent
40 Years
85 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin S. Yeom
Professor
Principal Investigators
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Ho-Joong Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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Mazor_001
Identifier Type: -
Identifier Source: org_study_id
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