General vs Spinal in Total Joint Arthroplasty (TJA)

University of Miami2,396 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

2,396

Conditions

Knee Osteoarthritis Hip Osteoarthritis

Interventions

General AnesthesiaPROCEDURE

Participants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.

Spinal AnesthesiaPROCEDURE

Participants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Length of hospital stay

Will be measured in hours.

Time frame: 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.

Time frame: 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.

Time frame: Baseline (up to 1 hour after surgery), up to 24 hours.

Prosthetic joint infection

Will be measured by the 2018 Musculoskeletal Infection Society criteria.

Time frame: Up to 90 days.

Superficial surgical site infection

Will be measured by the 2018 Musculoskeletal Infection Society criteria.

Time frame: Up to 90 days.

Number of periprosthetic fracture

Will be measured by the number of periprosthetic fracture.

Time frame: Up to 90 days.

Number of implant dislocation.

Will be measured by the number of implant dislocation.

Time frame: Up to 90 days.

Number of participants who are readmitted 90 days after surgery.

Will be measured by the number of participants who are readmitted 90 days after surgery.

Time frame: Up to 90 days.

Central Contacts

Victor H Hernandez, MD

CONTACT

305-689-5195 vhh1@med.miami.edu

Antonio M Fernandez-Perez, MS

CONTACT

305-689-5195 axf2089@miami.edu

Data from ClinicalTrials.gov

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General vs Spinal in Total Joint Arthroplasty (TJA)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts

Secondary Outcomes