NCT06747494 · University of Miami
General vs Spinal in Total Joint Arthroplasty (TJA)
What this study is about
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.
View original scientific description
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.
Will be measured in 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.
Score range from 0 to 10, higher score indicate higher pain scores.
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.
Prosthetic joint infection
Time frame: Up to 90 days.
Will be measured by the 2018 Musculoskeletal Infection Society criteria.
Superficial surgical site infection
Time frame: Up to 90 days.
Will be measured by the 2018 Musculoskeletal Infection Society criteria.
Number of periprosthetic fracture
Time frame: Up to 90 days.
Will be measured by the number of periprosthetic fracture.
Number of implant dislocation.
Time frame: Up to 90 days.
Will be measured by the number of implant dislocation.
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.
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.
Number of participant deaths.
Time frame: Up to 90 days.
Will be measured by the number of participants deaths.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Miami, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations