Osteoarthritis, Knee
Conditions
Keywords
TKA, Primary osteoarthritis
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.
Interventions
DRUGDexamethasone
Two 8 mg doses. One dose applied prior to incision and the other at POD1
DRUGMorphine
Morphine 0.1 mg per kg intravenous every 6 hours
DRUGOxycodone and acetaminophen
2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)
Sponsors
University of Puerto Rico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POD 3 Range of Motion | Measured at 7:00AM three days after surgery | — |
| POD 1 Range of Motion | Measured at 7:00AM the day after surgery | — |
| POD 2 Range of Motion | Measured at 7:00AM two days after surgery | — |
| POD 1 Visual Analogue Scale Pain Scores | Measured at 7:00AM day after surgery | Range: 0-10 (10 indicates highest degree of pain) |
| POD 2 Visual Analogue Scale Pain Scores | Measured at 7:00AM two days after surgery | Range: 0-10 (10 indicates highest degree of pain) |
| POD 3 Visual Analogue Scale Pain Scores | Measured at 7:00AM three days after surgery | Range: 0-10 (10 indicates highest degree of pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | From hospital admission to the date of discharge (About 3 days) | Measured in days |
| Daily Dextrose Concentration (mg/dL) | Measured at 7:00AM for 3 days after surgery | — |
Countries
Puerto Rico
Contacts
Primary ContactAlexandra M Claudio Marcano, MD
Backup ContactNorberto J Torres, MD
Outcome results
None listed