General vs Spinal in Total Joint Arthroplasty (TJA)

NCT06747494 | Recruiting

• 1 other identifier: 20240978
• Study Type: interventional
• Target: 2,396
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis

Keywords

Total joint arthroplasty; General anesthesia; Spinal anesthesia

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

Secondary Outcomes (1)

• Length of surgery.

  Up to 2 hours.

Study Arms (2)

General Anesthesia

EXPERIMENTAL

Participants in this group will receive general anesthesia for TJA for up to 2 hours.

Procedure: General Anesthesia

Spinal Anesthesia

EXPERIMENTAL

Participants in this group will receive spinal anesthesia for TJA for up to 2 hours.

Procedure: Spinal Anesthesia

Interventions

General Anesthesia PROCEDURE

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

General Anesthesia

Spinal Anesthesia PROCEDURE

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

Spinal Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing a primary total hip or knee arthroplasty
• Subjects must be capable of providing informed consent
• English or Spanish speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Anesthesia, General; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anesthesia, Conduction

Study Officials

• Victor H Hernandez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)