Clinical trial NCT06042426: Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
Official title: Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: TKA
Primary osteoarthritis
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: POD 1 Visual Analogue Scale Pain Scores
timeFrame: Measured at 7:00AM day after surgery
measure: POD 2 Visual Analogue Scale Pain Scores
timeFrame: Measured at 7:00AM two days after surgery
measure: POD 3 Visual Analogue Scale Pain Scores
timeFrame: Measured at 7:00AM three days after surgery
measure: POD 1 Range of Motion
timeFrame: Measured at 7:00AM the day after surgery
measure: POD 2 Range of Motion
timeFrame: Measured at 7:00AM two days after surgery
measure: POD 3 Range of Motion
timeFrame: Measured at 7:00AM three days after surgery
Secondary outcomes:
measure: Daily Dextrose Concentration (mg/dL)
timeFrame: Measured at 7:00AM for 3 days after surgery
measure: Length of Stay
timeFrame: From hospital admission to the date of discharge (About 3 days)
Other outcomes:
Locations:
city: Carolina
country: Puerto Rico
facility: University of Puerto Ric-Dr. Federico Trilla Hospital
Study officials:
affiliation: Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
name: Antonio M López Otero, MD
role: PRINCIPAL_INVESTIGATOR
References: