General vs Spinal in Total Joint Arthroplasty (TJA)
Part of paid clinical trials in Miami, Florida.
- Sponsor
- University of Miami
- Study ID
- NCT06747494
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- General Anesthesia — PROCEDUREParticipants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.
- Spinal Anesthesia — PROCEDUREParticipants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.
Study Details
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.
Key Dates
- Start date
- Feb 1, 2025
- Status verified
- Feb 2026
- Primary completion
- Mar 1, 2030
- Completion
- Mar 1, 2030
Study Design
- Enrollment
- 2,396 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: General AnesthesiaParticipants in this group will receive general anesthesia for TJA for up to 2 hours.
- Experimental: Spinal AnesthesiaParticipants in this group will receive spinal anesthesia for TJA for up to 2 hours.
Primary Outcome Measure
Length of hospital stay [ Time Frame: Up to 72 hours. ]
Central Contacts
- Victor H Hernandez, MD305-689-5195
- Antonio M Fernandez-Perez, MS305-689-5195
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | Victor H Hernandez, MD (PRINCIPAL_INVESTIGATOR) |
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