RecruitingNCT07442812

Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty

The Role of Dexamethasone in Total Knee Arthroplasty: Effects of Oral and Intravenous Administration on Early Postoperative Pain and Mobilization


Sponsor

Haseki Training and Research Hospital

Enrollment

270 participants

Start Date

Mar 31, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 50 YearsMax Age: 80 Years

Inclusion Criteria7

  • 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 Criteria11

  • 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

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Interventions

OTHERRoutine perioperative management

This is a prospective observational cohort study. No intervention is assigned by the investigators. Patients are managed according to the routine perioperative dexamethasone protocols of the surgeon chosen by the patient. One cohort receives intravenous dexamethasone (8 mg preoperatively and 4 mg postoperatively), one cohort receives oral dexamethasone (8 mg preoperatively and 4 mg postoperatively), and a control cohort receives no dexamethasone. All other perioperative and postoperative treatments are provided according to standard institutional practice and are not influenced by study participation.


Locations(1)

Sultangazi Haseki Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

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NCT07442812


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