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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anesthesia | Experimental | Participants in this group will receive general anesthesia for TJA for up to 2 hours. |
|
| Spinal Anesthesia | Experimental | Participants in this group will receive spinal anesthesia for TJA for up to 2 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General Anesthesia | Procedure | Participants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Will be measured in hours. | Up to 72 hours. |
| 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. | Baseline (up to 1 hour after surgery), up to 24 hours. |
| Change in Patient Nausea Scores as measured by the Conditioning Scoring Criteria | Score range from 0 to 9, higher score indicate higher nausea scores. | Baseline (up to 1 hour after surgery), up to 24 hours. |
| Prosthetic joint infection | Will be measured by the 2018 Musculoskeletal Infection Society criteria. | Up to 90 days. |
| Superficial surgical site infection | Will be measured by the 2018 Musculoskeletal Infection Society criteria. | Up to 90 days. |
| Number of periprosthetic fracture | Will be measured by the number of periprosthetic fracture. | Up to 90 days. |
| Number of implant dislocation. | Will be measured by the number of implant dislocation. | Up to 90 days. |
| Number of participants who are readmitted 90 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of surgery. | Will be measured in hours. | Up to 2 hours. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with contraindications for spinal anesthesia such as:
Patients with contraindications for general anesthesia such as:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor H Hernandez, MD | Contact | 305-689-5195 | vhh1@med.miami.edu | |
| Antonio M Fernandez-Perez, MS | Contact | 305-689-5195 | axf2089@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Victor H Hernandez, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D000775 | Anesthesia, Spinal |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000765 | Anesthesia, Conduction |
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| Spinal Anesthesia | Procedure | Participants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care. |
|
Will be measured by the number of participants who are readmitted 90 days after surgery. |
| Up to 90 days. |
| Number of participants who receive revision surgery 90 days after surgery. | Will be measured by the number of participants who receive revision surgery 90 days after surgery. | Up to 90 days. |
| Number of participant deaths. | Will be measured by the number of participants deaths. | Up to 90 days. |
| D012216 |
| Rheumatic Diseases |