Study Results
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View full resultsBasic Information
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TERMINATED
NA
20 participants
INTERVENTIONAL
2017-06-20
2018-12-28
Brief Summary
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Elevator \& Retractor \[SISTER\] device to assess:
* Effects on operative time and efficiency of exposure in open lumbar spine cases.
* Effect on total blood loss during the exposure part of the operation.
* Rate of clogging of suction device.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Use of Cobb device
Use of SISTER device during surgery
SISTER device
Use of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery
Control
Standard exposure technique and instruments will be used during surgery
No interventions assigned to this group
Interventions
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SISTER device
Use of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing lumbar one to sacral one open instrumentation
* Surgery performed by the Departments of Neurological Surgery and Orthopedics at the University of MIami Miller School of Medicine
Exclusion Criteria
* Procedure does not involve instrumentation
* Prior lumbar spine surgery involving more than one level
* BMI less than 20 or greater than 35
* Known bleeding conditions ( ex. Factor V Leiden, Von Willebrand)
* Routinely taking anticoagulation medicine (ex. aspirin 325 mg/day, Plavix)
* Operative cases where a single surgeon performs both sides of exposure
* Pregnant women
* Prisoners
* Adults unable to consent
22 Years
99 Years
ALL
Yes
Sponsors
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Ludwig Medical Corporation
UNKNOWN
University of Miami
OTHER
Responsible Party
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Ian Cote
Assistant Professor
Principal Investigators
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Ian Cõté, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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Jackson Memorial Hospital
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20161061
Identifier Type: -
Identifier Source: org_study_id
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