Osteoarthritis, KneePhase 4NCT06042426
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
A Phase 4 study testing Dexamethasone, Morphine and Oxycodone and acetaminophen in people with Osteoarthritis, Knee, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The purpose of this study is to evaluate the efficacy of an intravenous (IV) perioperative dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to opioid-based pain treatment following TKA. Read more about this study
- Who is it for?
- Ages 24 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Dexamethasone, Morphine and Oxycodone and acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Sep 2023to Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 24 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with Hispanic self-identification
- Primary robotic-assisted TKA for treatment of primary osteoarthritis
- Age ≥ 21
- Receiving seven days of inpatient rehabilitation after medical discharge
- Patient with adequate glycemic control (HbA1c<7.5%)
- Patients who provide written informed consent
Who cannot join
- Age ≤ 21
- Chronic steroid use prior to surgery
- Previous allergies or adverse reactions to steroid drugs
- Indications for surgery other than primary osteoarthritis
- History of narcotics abuse such as opioids
- Surgeries performed without robotic-assistance
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- Outpatient or Home rehabilitation programs after medical discharge
- Requirement of revision surgery orthopaedic implants
- Patients with inadequate glycemic control (HbA1c≥7.5%)
- Other medical conditions, such as osteoporosis, fungal infections, glaucoma, joint infections, peptic ulcer disease which could worsen with steroid administration.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Ric-Dr. Federico Trilla Hospital
Carolina, 00984
Antonio M Otero López, MD, 787-758-2525, antonio.otero3@upr.edu
About this study
Official title: Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial
The purpose of this study is to evaluate the efficacy of an intravenous (IV) perioperative dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to opioid-based pain treatment following TKA. The study hopefully validates the use of a two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores in patients undergoing primary, unilateral TKA for osteoarthritis. One dose will be applied prior to incision and the other at post-operative day (POD) 1.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Dexamethasone, Morphine, Oxycodone and acetaminophen
- Keywords
- TKA, Primary osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Two 8 mg doses. One dose applied prior to incision and the other at POD1
MorphineDrug
Morphine 0.1 mg per kg intravenous every 6 hours
Oxycodone and acetaminophenDrug
2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving intravenous dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone |
| Patients receiving intravenous morphine and oral oxycodone | Active comparator | Not described Receives: Drug: Morphine; Drug: Oxycodone and acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
POD 1 Visual Analogue Scale Pain Scores
Range: 0-10 (10 indicates highest degree of pain)
Measured: Measured at 7:00AM day after surgery
POD 2 Visual Analogue Scale Pain Scores
Range: 0-10 (10 indicates highest degree of pain)
Measured: Measured at 7:00AM two days after surgery
POD 3 Visual Analogue Scale Pain Scores
Range: 0-10 (10 indicates highest degree of pain)
Measured: Measured at 7:00AM three days after surgery
POD 1 Range of Motion
Measured: Measured at 7:00AM the day after surgery
POD 2 Range of Motion
Measured: Measured at 7:00AM two days after surgery
POD 3 Range of Motion
Measured: Measured at 7:00AM three days after surgery
Secondary outcomes (2)
Daily Dextrose Concentration (mg/dL)
Measured: Measured at 7:00AM for 3 days after surgery
Length of Stay
Measured in days
Measured: From hospital admission to the date of discharge (About 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio M López Otero, MD, Principal investigator, Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042426
- Sponsor's protocol ID
- 2306117408
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06042426
- Acronym / sponsor ID
- 2306117408
- Conditions
- Osteoarthritis, Knee
- Keywords
- TKA, Primary osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 18 Sep 2023 (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 study is to evaluate the efficacy of an intravenous (IV) perioperative dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to opioid-based pain treatment following TKA. The study hopefully validates the use of a two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores in patients undergoing primary, unilateral TKA for osteoarthritis. One dose will be applied prior to incision and the other at post-operative day (POD) 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving intravenous dexamethasone | Experimental | Drug: Dexamethasone |
| Patients receiving intravenous morphine and oral oxycodone | Active comparator | Drug: Morphine, Drug: Oxycodone and acetaminophen |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with Hispanic self-identification
- Primary robotic-assisted TKA for treatment of primary osteoarthritis
- Age ≥ 21
- Receiving seven days of inpatient rehabilitation after medical discharge
- Patient with adequate glycemic control (HbA1c<7.5%)
Key exclusion criteria (10 listed)
- Age ≤ 21
- Chronic steroid use prior to surgery
- Previous allergies or adverse reactions to steroid drugs
- Indications for surgery other than primary osteoarthritis
- History of narcotics abuse such as opioids
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 |
|---|---|---|
| DexamethasoneTwo 8 mg doses. One dose applied prior to incision and the other at POD1 | Drug | Patients receiving intravenous dexamethasone |
| MorphineMorphine 0.1 mg per kg intravenous every 6 hours | Drug | Patients receiving intravenous morphine and oral oxycodone |
| Oxycodone and acetaminophen2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs) | Drug | Patients receiving intravenous morphine and oral oxycodone |
Primary outcome
POD 1 Visual Analogue Scale Pain Scores
Time frame: Measured at 7:00AM day after surgery
Range: 0-10 (10 indicates highest degree of pain)
POD 2 Visual Analogue Scale Pain Scores
Time frame: Measured at 7:00AM two days after surgery
Range: 0-10 (10 indicates highest degree of pain)
POD 3 Visual Analogue Scale Pain Scores
Time frame: Measured at 7:00AM three days after surgery
Range: 0-10 (10 indicates highest degree of pain)
POD 1 Range of Motion
Time frame: Measured at 7:00AM the day after surgery
POD 2 Range of Motion
Time frame: Measured at 7:00AM two days after surgery
POD 3 Range of Motion
Time frame: Measured at 7:00AM three days after surgery
2 secondary outcomes
Daily Dextrose Concentration (mg/dL)
Time frame: Measured at 7:00AM for 3 days after surgery
Length of Stay
Time frame: From hospital admission to the date of discharge (About 3 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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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. This study is not recruiting at the moment.
Antonio M López Otero, MD principal investigator
Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Morphine and Oxycodone and acetaminophen in people with Osteoarthritis, Knee, run by University of Puerto Rico at 1 site in Puerto Rico.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. 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 Puerto Rico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra M Claudio Marcano, MD (787-221-5210, alexandra.claudio1@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POD 1 Visual Analogue Scale Pain Scores (time frame: Measured at 7:00AM day after surgery). The study lists 6 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 Sep 2023.