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NCT Number: NCT06747494

General vs Spinal in Total Joint Arthroplasty (TJA)

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Hip Osteoarthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Victor H Hernandez, MD

CONTACT

[email protected]

305-689-5195

Victor H Hernandez, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General Anesthesia

Procedure

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

Spinal anesthesia

Procedure

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

Primary outcomes

  1. Length of hospital stay

    Time frame: Up to 72 hours.

    Will be measured in hours.

  2. 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.

    Score range from 0 to 10, higher score indicate higher pain scores.

  3. 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.

    Score range from 0 to 9, higher score indicate higher nausea scores.

  4. Prosthetic joint infection

    Time frame: Up to 90 days.

    Will be measured by the 2018 Musculoskeletal Infection Society criteria.

  5. Superficial surgical site infection

    Time frame: Up to 90 days.

    Will be measured by the 2018 Musculoskeletal Infection Society criteria.

  6. Number of periprosthetic fracture

    Time frame: Up to 90 days.

    Will be measured by the number of periprosthetic fracture.

  7. Number of implant dislocation.

    Time frame: Up to 90 days.

    Will be measured by the number of implant dislocation.

  8. Number of participants who are readmitted 90 days after surgery.

    Time frame: Up to 90 days.

    Will be measured by the number of participants who are readmitted 90 days after surgery.

  9. Number of participants who receive revision surgery 90 days after surgery.

    Time frame: Up to 90 days.

    Will be measured by the number of participants who receive revision surgery 90 days after surgery.

  10. Number of participant deaths.

    Time frame: Up to 90 days.

    Will be measured by the number of participants deaths.

Secondary outcomes

  1. Length of surgery.

    Time frame: Up to 2 hours.

    Will be measured in hours.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio M Fernandez-Perez, MS

CONTACT

[email protected]

305-689-5195

Victor H Hernandez, MD

CONTACT

[email protected]

305-689-5195

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 24, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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