RecruitingNot ApplicableNCT06747494

General vs Spinal in Total Joint Arthroplasty (TJA)

General Versus Spinal Anesthesia for Total Joint Arthroplasty: A Prospective Randomized Trial


Sponsor

University of Miami

Enrollment

2,396 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Patients undergoing a primary total hip or knee arthroplasty
  • Subjects must be capable of providing informed consent
  • English or Spanish speaking

Exclusion Criteria14

  • 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

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Interventions

PROCEDUREGeneral Anesthesia

Participants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.

PROCEDURESpinal Anesthesia

Participants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.


Locations(1)

University of Miami

Miami, Florida, United States

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NCT06747494


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