This prospective observational cohort study aims to evaluate the association between perioperative dexamethasone administration and early postoperative recovery following primary total knee arthroplasty. In routine clinical practice, dexamethasone may be administered orally, intravenously, or not administered, depending on the surgeon's established perioperative protocol.
The primary objective is to assess early postoperative recovery in terms of pain intensity, functional mobility, and knee joint range of motion. Secondary objectives include evaluation of inflammatory response, postoperative metabolic changes, opioid requirement, and the severity of postoperative nausea and vomiting (PONV).
Group allocation is non-randomized and determined solely by the standard perioperative management approach routinely applied by the surgeon selected by the patient. No additional interventions are introduced for research purposes. All outcomes are assessed prospectively during the early postoperative period.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 50 and 80 years
* Diagnosis of primary knee osteoarthritis (primary gonarthrosis)
* Scheduled for elective primary total knee arthroplasty
* ASA physical status I or II
* Ability to ambulate independently (with or without assistive devices) preoperatively
* Ability to understand study procedures and complete pain and functional assessments
* Provision of written informed consent
Exclusion Criteria:
* Revision total knee arthroplasty
* History of knee joint infection
* Inflammatory arthritis (e.g., rheumatoid arthritis)
* Chronic systemic corticosteroid use
* Uncontrolled diabetes mellitus
* Known endocrine disorders affecting glucose metabolism
* Active infection at any site
* Known hypersensitivity to corticosteroids
* Severe hepatic, renal, or cardiac disease
* Neurological or musculoskeletal disorders affecting gait or balance
* Inability or unwillingness to comply with study procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares oral versus intravenous dexamethasone for my knee replacement — can you explain whether one delivery method is already considered standard care at your hospital, and what the main reason for testing them head-to-head would be for someone in my situation?
2The trial is measuring postoperative opioid use as one of its main outcomes — given my specific health history, how might participation affect how my pain is managed after surgery compared to what you'd normally prescribe me?
3Since this trial tracks nausea and vomiting scores after surgery, does that mean the way dexamethasone is given — by mouth or by IV — might change my risk of feeling sick after my knee replacement, and is that something you'd normally be managing differently for me anyway?
4The study is still recruiting and is listed as Phase NA, which suggests it may be more of a practical comparison than an early safety study — does that mean the risks of both options are already reasonably well understood, and how would you weigh participation against just following your usual protocol for total knee replacement?
5Since the trial measures functional mobility using the Timed Up and Go Test, could you help me understand whether joining this study would change anything about my physical therapy schedule or how quickly I'd be expected to get moving after surgery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Pain Intensity Measured with Visiual Analog Scale (VAS)
Timeframe: Measuring once in the preoperative period and every 6 hours during the first 48 hours after surgery.
2
Functional Mobility (Timed Up and Go Test)
Timeframe: Preoperatively and daily during the first 2 postoperative days.
3
Nausea and Vomiting (PONV) Score
Timeframe: Assessed daily during the first 2 postoperative days.
4
Postoperative Opioid Requirement
Timeframe: During the first 48 hours after surgery.