Knee OsteoarthritisNCT06747494
General vs Spinal in Total Joint Arthroplasty (TJA)
A study testing General Anesthesia and Spinal Anesthesia in people with Knee Osteoarthritis and Hip Osteoarthritis, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis
- What is being tested?
- General Anesthesia and Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,396 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 1 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing a primary total hip or knee arthroplasty
- Subjects must be capable of providing informed consent
- English or Spanish speaking
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Victor H Hernandez, MD, 305-689-5195, vhh1@med.miami.edu
Victor H Hernandez, MD
About this study
Official title: General Versus Spinal Anesthesia for Total Joint Arthroplasty: A Prospective Randomized Trial
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
- Being tested
- General Anesthesia, Spinal Anesthesia
- Keywords
- Total joint arthroplasty, General anesthesia, Spinal anesthesia
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaProcedure or surgery
Participants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care.
Spinal AnesthesiaProcedure or surgery
Participants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Experimental | Participants in this group will receive general anesthesia for TJA for up to 2 hours. Receives: Procedure: General Anesthesia |
| Spinal Anesthesia | Experimental | Participants in this group will receive spinal anesthesia for TJA for up to 2 hours. Receives: Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Will be measured in hours.
Measured: 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.
Measured: 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.
Measured: Baseline (up to 1 hour after surgery), up to 24 hours.
Prosthetic joint infection
Will be measured by the 2018 Musculoskeletal Infection Society criteria.
Measured: Up to 90 days.
Superficial surgical site infection
Will be measured by the 2018 Musculoskeletal Infection Society criteria.
Measured: Up to 90 days.
Number of periprosthetic fracture
Will be measured by the number of periprosthetic fracture.
Measured: Up to 90 days.
Number of implant dislocation.
Will be measured by the number of implant dislocation.
Measured: 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.
Measured: 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.
Measured: Up to 90 days.
Number of participant deaths.
Will be measured by the number of participants deaths.
Measured: Up to 90 days.
Secondary outcomes (1)
Length of surgery.
Will be measured in hours.
Measured: Up to 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Feb 2025
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Hernandez, University of Miami
- Investigators
- Victor H Hernandez, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747494
- Sponsor's protocol ID
- 20240978
- Status last verified
- Feb 2026
- First submitted
- 18 Dec 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Versus Spinal Anesthesia for Total Joint Arthroplasty: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06747494
- Acronym / sponsor ID
- 20240978
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Keywords
- Total joint arthroplasty, General anesthesia, Spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,396 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Experimental | Procedure: General AnesthesiaParticipants in this group will receive general anesthesia for TJA for up to 2 hours. |
| Spinal Anesthesia | Experimental | Procedure: Spinal AnesthesiaParticipants in this group will receive spinal anesthesia for TJA for up to 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing a primary total hip or knee arthroplasty
- Subjects must be capable of providing informed consent
- English or Spanish speaking
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General AnesthesiaParticipants will receive a one-time general anesthesia dose during the total joint arthroplasty procedure as per standard of care. | Procedure or surgery | General Anesthesia |
| Spinal AnesthesiaParticipants will receive a one-time spinal anesthesia dose during the total joint arthroplasty procedure as per standard of care. | Procedure or surgery | Spinal Anesthesia |
Primary outcome
Length of hospital stay
Time frame: Up to 72 hours.
Will be measured in hours.
Change in Patient Pain Scores as measured by the Numeric Rating Pain Scale
Time frame: 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
Time frame: 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
Time frame: Up to 90 days.
Will be measured by the 2018 Musculoskeletal Infection Society criteria.
Superficial surgical site infection
Time frame: Up to 90 days.
Will be measured by the 2018 Musculoskeletal Infection Society criteria.
Number of periprosthetic fracture
Time frame: Up to 90 days.
Will be measured by the number of periprosthetic fracture.
Number of implant dislocation.
Time frame: Up to 90 days.
Will be measured by the number of implant dislocation.
Number of participants who are readmitted 90 days after surgery.
Time frame: 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.
Time frame: Up to 90 days.
Will be measured by the number of participants who receive revision surgery 90 days after surgery.
Number of participant deaths.
Time frame: Up to 90 days.
Will be measured by the number of participants deaths.
1 secondary outcome
Length of surgery.
Time frame: Up to 2 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor H Hernandez, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia and Spinal Anesthesia in people with Knee Osteoarthritis and Hip Osteoarthritis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor H Hernandez, MD (305-689-5195, vhh1@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Up to 72 hours.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.