NCT07442812 Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty
| NCT ID | NCT07442812 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haseki Training and Research Hospital |
| Condition | Knee Osteoarthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 270 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 270 participants in total. It began in 2026-03-31 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Mehmet Ersin, Associate Professor
PRINCIPAL INVESTIGATOR
Sultangazi Haseki Training and Research Hospital
Frequently Asked Questions
Who can join the NCT07442812 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07442812 currently recruiting?
Yes, NCT07442812 is actively recruiting participants. Contact the research team at dratahaneryilmaz@gmail.com for enrollment information.
Where is the NCT07442812 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07442812 clinical trial?
NCT07442812 is sponsored by Haseki Training and Research Hospital. The principal investigator is Mehmet Ersin, Associate Professor at Sultangazi Haseki Training and Research Hospital. The trial plans to enroll 270 participants.