General vs Spinal in Total Joint Arthroplasty (TJA)

University of Miami

Status: Enrolling

Conditions: Hip Osteoarthritis; Knee Osteoarthritis

Treatments: Procedure: General Anesthesia; Procedure: Spinal Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06747494

20240978

Details and patient eligibility

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.

Enrollment: 2,396 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,396 participants in 2 patient groups

General Anesthesia

Experimental group

Description:

Participants in this group will receive general anesthesia for TJA for up to 2 hours.

Treatment:

Procedure: General Anesthesia

Spinal Anesthesia

Experimental group

Description:

Participants in this group will receive spinal anesthesia for TJA for up to 2 hours.

Treatment:

Procedure: Spinal Anesthesia