General vs Spinal in Total Joint Arthroplasty (TJA) (NCT06747494) | Clinical Trial Compass
RecruitingNot Applicable
General vs Spinal in Total Joint Arthroplasty (TJA)
United States2,396 participantsStarted 2025-02-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Length of hospital stay
Timeframe: Up to 72 hours.
2
Change in Patient Pain Scores as measured by the Numeric Rating Pain Scale
Timeframe: Baseline (up to 1 hour after surgery), up to 24 hours.
3
Change in Patient Nausea Scores as measured by the Conditioning Scoring Criteria
Timeframe: Baseline (up to 1 hour after surgery), up to 24 hours.