Recruiting

General vs. Spinal

Sponsor:

University of Miami

Code:

NCT06747494

Conditions

Knee Osteoarthritis

Hip Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

General Anesthesia

Spinal Anesthesia

Study Details

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.

Conditions

Knee Osteoarthritis

Hip Osteoarthritis

Study ID

NCT06747494

Start date

Feb 1, 2025

Status verified date

Feb, 2026

Completion date

Mar 1, 2030

Anticipated

Primary completion date

Mar 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2396 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: General Anesthesia

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

experimental: Spinal Anesthesia

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

Interventions

General Anesthesia

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

Spinal Anesthesia

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

Primary outcome measure

  • Length of hospital stay [ Time Frame: Up to 72 hours. ]
  • Change in Patient Pain Scores as measured by the Numeric Rating Pain Scale [ Time Frame: Baseline (up to 1 hour after surgery), up to 24 hours. ]
  • Change in Patient Nausea Scores as measured by the Conditioning Scoring Criteria [ Time Frame: Baseline (up to 1 hour after surgery), up to 24 hours. ]
  • Prosthetic joint infection [ Time Frame: Up to 90 days. ]
  • Superficial surgical site infection [ Time Frame: Up to 90 days. ]
  • Number of periprosthetic fracture [ Time Frame: Up to 90 days. ]
  • Number of implant dislocation. [ Time Frame: Up to 90 days. ]
  • Number of participants who are readmitted 90 days after surgery. [ Time Frame: Up to 90 days. ]
  • Number of participants who receive revision surgery 90 days after surgery. [ Time Frame: Up to 90 days. ]
  • Number of participant deaths. [ Time Frame: Up to 90 days. ]

Central Contacts and Locations

Central contacts

Victor H Hernandez, MD

305-689-5195vhh1@med.miami.edu

Antonio M Fernandez-Perez, MS

305-689-5195axf2089@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Victor H Hernandez, MD

305-689-5195vhh1@med.miami.edu

Principal Investigator:

Victor H Hernandez, MD

More Information

Sponsor

University of Miami

Last update posted

Mar 18, 2026

Last verified

Feb, 2026

Keywords

  • Total joint arthroplasty
  • General anesthesia
  • Spinal anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-18.