Clinical Trial Finder

General vs Spinal in Total Joint Arthroplasty (TJA)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06747494
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Miami
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Victor H Hernandez, MD
Principal Investigator Affiliation University of Miami
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthritis, Hip Osteoarthritis
Arms & Interventions

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

Victor H Hernandez, MD

[email protected]

305-689-5195

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