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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RECRUITING
NA
2396 participants
INTERVENTIONAL
2025-02-01
2026-03-01
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
SUPPORTIVE_CARE
NONE
Study Groups
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General Anesthesia
Participants in this group will receive general anesthesia for TJA for up to 2 hours.
General Anesthesia
Participants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.
Spinal Anesthesia
Participants in this group will receive spinal anesthesia for TJA for up to 2 hours.
Spinal Anesthesia
Participants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.
Interventions
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General Anesthesia
Participants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.
Spinal Anesthesia
Participants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.
Eligibility Criteria
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Inclusion Criteria
* Subjects must be capable of providing informed consent
* English or Spanish speaking
Exclusion Criteria
* Prior lumbar surgery with hardware insertion
* Elevated intracranial pressure
* Infection at the site of the procedure
* Thrombocytopenia or coagulopathy
* Severe mitral and aortic stenosis and left ventricular outflow obstruction
* Severe spine pathology (spinal stenosis, spondylolisthesis, spondylosis) with radiculopathy and/or neurogenic claudication
* Preexisting neurological disease
Patients with contraindications for general anesthesia such as:
* Congestive heart failure
* Severe aortic stenosis
* Patient is unable/unwilling to consent
* Current pregnancy or women planning on becoming pregnant in the next year, and women who think they might be pregnant, or women who become pregnant during the study period will be removed from the study.
* Prisoners
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Victor Hugo Hernandez
Professor of Clinical
Principal Investigators
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Victor H Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, 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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20240978
Identifier Type: -
Identifier Source: org_study_id
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