General vs Spinal in Total Joint Arthroplasty (TJA)
Recruiting · NCT06747494 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
General AnesthesiaSpinal Anesthesia
What this trial is about
The purpose of this research is to compare post-operative outcomes from patients undergoing TJA. The study team wants to learn about outcomes like length of hospital stay, post-operative pain scores, post-operative nausea, deep and superficial surgical site infection, periprosthetic fracture (a broken bone that occurs around an orthopaedic implant), implant dislocation, readmission rates, and revision rates.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients undergoing a primary total hip or knee arthroplasty
- Subjects must be capable of providing informed consent
- English or Spanish speaking
Exclusion criteria
- Patients with contraindications for spinal anesthesia such as:
- 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
Where it is running
1 location listed across 1 US state.
- University of Miami - Miami, Florida, United States