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Recruiting NCT06747494

General vs Spinal in Total Joint Arthroplasty (TJA)

No phase Interventional Knee Osteoarthritis Hip Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: General Anesthesia, Spinal Anesthesia.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Hip Osteoarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure General Anesthesia
    Participants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.
  • Procedure Spinal Anesthesia
    Participants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.

Primary outcome measures

  • 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.]
Secondary outcome measures (1)
  • Length of surgery. [Time frame: Up to 2 hours.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06747494 · 20240978

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗