Hip Osteoarthritis, Knee Osteoarthritis
Conditions
Keywords
Total joint arthroplasty, General anesthesia, Spinal anesthesia
Brief 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.
Interventions
PROCEDUREGeneral Anesthesia
Participants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.
PROCEDURESpinal Anesthesia
Participants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of implant dislocation. | Up to 90 days. | Will be measured by the number of implant dislocation. |
| Number of participants who are readmitted 90 days after surgery. | 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. | Up to 90 days. | Will be measured by the number of participants who receive revision surgery 90 days after surgery. |
| Number of participant deaths. | Up to 90 days. | Will be measured by the number of participants deaths. |
| Prosthetic joint infection | Up to 90 days. | Will be measured by the 2018 Musculoskeletal Infection Society criteria. |
| Change in Patient Nausea Scores as measured by the Conditioning Scoring Criteria | Baseline (up to 1 hour after surgery), up to 24 hours. | Score range from 0 to 9, higher score indicate higher nausea scores. |
| Superficial surgical site infection | Up to 90 days. | Will be measured by the 2018 Musculoskeletal Infection Society criteria. |
| Number of periprosthetic fracture | Up to 90 days. | Will be measured by the number of periprosthetic fracture. |
| Length of hospital stay | Up to 72 hours. | Will be measured in hours. |
| Change in Patient Pain Scores as measured by the Numeric Rating Pain Scale | Baseline (up to 1 hour after surgery), up to 24 hours. | Score range from 0 to 10, higher score indicate higher pain scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of surgery. | Up to 2 hours. | Will be measured in hours. |
Countries
United States
Contacts
CONTACTVictor H Hernandez, MD
CONTACTAntonio M Fernandez-Perez, MS
PRINCIPAL_INVESTIGATORVictor H Hernandez, MD
University of Miami
Outcome results
None listed