Clinical trial NCT06747494: General vs Spinal in Total Joint Arthroplasty (TJA)
Official title: General Versus Spinal Anesthesia for Total Joint Arthroplasty: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Keywords: Total joint arthroplasty
General anesthesia
Spinal anesthesia
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 2396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: Up to 72 hours.
measure: Change in Patient Pain Scores as measured by the Numeric Rating Pain Scale
timeFrame: Baseline (up to 1 hour after surgery), up to 24 hours.
measure: Change in Patient Nausea Scores as measured by the Conditioning Scoring Criteria
timeFrame: Baseline (up to 1 hour after surgery), up to 24 hours.
measure: Prosthetic joint infection
timeFrame: Up to 90 days.
measure: Superficial surgical site infection
timeFrame: Up to 90 days.
measure: Number of periprosthetic fracture
timeFrame: Up to 90 days.
measure: Number of implant dislocation.
timeFrame: Up to 90 days.
measure: Number of participants who are readmitted 90 days after surgery.
timeFrame: Up to 90 days.
measure: Number of participants who receive revision surgery 90 days after surgery.
timeFrame: Up to 90 days.
measure: Number of participant deaths.
timeFrame: Up to 90 days.
Secondary outcomes:
measure: Length of surgery.
timeFrame: Up to 2 hours.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Victor H Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: