General vs Spinal in Total Joint Arthroplasty (TJA)

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis; Hip Osteoarthritis

• Registration Number: NCT06747494
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-24
• Status Verified: 2025-02
• Study Start: 2025-02-01
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.
Prosthetic joint infection	Up to 90 days.	Will be measured by the 2018 Musculoskeletal Infection Society criteria.
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.
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.

Secondary Outcome Measures

Name	Time	Method
Length of surgery.	Up to 2 hours.	Will be measured in hours.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States