General vs Spinal in Total Joint Arthroplasty (TJA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing a primary total hip or knee arthroplasty
Subjects must be capable of providing informed consent
English or Spanish speaking
Disqualifiers
Prior lumbar surgery with hardware insertion
Elevated intracranial pressure
Infection at the site of the procedure
Thrombocytopenia or coagulopathy
Trial design
Design model
Parallel
Treatments tested in this trial
General Anesthesia
Procedure/SurgeryParticipants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.
Spinal Anesthesia
Procedure/SurgeryParticipants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.
Treatment groups
2,396 Participants
are divided into 2 treatment groupsGroup A: General AnesthesiaExperimental treatment 1 intervention
Group B: Spinal AnesthesiaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Length of hospital stay
Will be measured in hours.
Time frame
Up to 72 hours.2
Change in Patient Pain Scores as measured by the Numeric Rating Pain Scale
Score range from 0 to 10, higher score indicate higher pain scores.
Time frame
Baseline (up to 1 hour after surgery), up to 24 hours.3
Change in Patient Nausea Scores as measured by the Conditioning Scoring Criteria
Score range from 0 to 9, higher score indicate higher nausea scores.
Time frame
Baseline (up to 1 hour after surgery), up to 24 hours.4
Prosthetic joint infection
Will be measured by the 2018 Musculoskeletal Infection Society criteria.
Time frame
Up to 90 days.Secondary outcomes
1
Length of surgery.
Will be measured in hours.
Time frame
Up to 2 hours.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov