General vs Spinal in Total Joint Arthroplasty (TJA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Intervention / Treatment: Procedure: General Anesthesia; Procedure: Spinal Anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 2396
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victor H Hernandez, MD; Phone Number: 305-689-5195; Email: vhh1@med.miami.edu
• Study Contact Backup: Name: Antonio M Fernandez-Perez, MS; Phone Number: 305-689-5195; Email: axf2089@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Victor H Hernandez, MD
      • Contact: Victor H Hernandez, MD; Phone Number: 305-689-5195; Email: vhh1@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: General Anesthesia; Participants in this group will receive general anesthesia for TJA for up to 2 hours.	Procedure: General Anesthesia; Participants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.
Experimental: Spinal Anesthesia; Participants in this group will receive spinal anesthesia for TJA for up to 2 hours.	Procedure: Spinal Anesthesia; Participants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Will be measured in hours.	Up to 72 hours.
Change in Patient Pain Scores as measured by the Numeric Rating Pain Scale	Score range from 0 to 10, higher score indicate higher pain scores.	Baseline (up to 1 hour after surgery), up to 24 hours.
Change in Patient Nausea Scores as measured by the Conditioning Scoring Criteria	Score range from 0 to 9, higher score indicate higher nausea scores.	Baseline (up to 1 hour after surgery), up to 24 hours.
Prosthetic joint infection	Will be measured by the 2018 Musculoskeletal Infection Society criteria.	Up to 90 days.
Superficial surgical site infection	Will be measured by the 2018 Musculoskeletal Infection Society criteria.	Up to 90 days.
Number of periprosthetic fracture	Will be measured by the number of periprosthetic fracture.	Up to 90 days.
Number of implant dislocation.	Will be measured by the number of implant dislocation.	Up to 90 days.
Number of participants who are readmitted 90 days after surgery.	Will be measured by the number of participants who are readmitted 90 days after surgery.	Up to 90 days.
Number of participants who receive revision surgery 90 days after surgery.	Will be measured by the number of participants who receive revision surgery 90 days after surgery.	Up to 90 days.
Number of participant deaths.	Will be measured by the number of participants deaths.	Up to 90 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of surgery.	Will be measured in hours.	Up to 2 hours.

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Victor H Hernandez, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Spinal anesthesia; General anesthesia; Total joint arthroplasty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Anesthesia, Spinal; Anesthesia, General
• Other Study ID Numbers: 20240978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No