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NCT06747494 | RECRUITING | Knee Osteoarthritis

General vs Spinal in Total Joint Arthroplasty (TJA)
Sponsor:

University of Miami

Information provided by (Responsible Party):

Victor Hugo Hernandez

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.

Condition or disease

Knee Osteoarthritis

Hip Osteoarthritis

Intervention/treatment

General Anesthesia

Spinal Anesthesia

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 2396 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : General Versus Spinal Anesthesia for Total Joint Arthroplasty: A Prospective Randomized Trial
Actual Study Start Date : 2025-02-01
Estimated Primary Completion Date : 2026-03-01
Estimated Study Completion Date : 2026-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
General vs Spinal in Total Joint Arthroplasty (TJA)

Location Details

NCT06747494

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How to Participate

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Locations

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136