Knee OsteoarthritisTKANCT07442812
Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty
An observational study of Knee Osteoarthritis and Gonarthrosis; Primary, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study aims to evaluate the association between perioperative dexamethasone administration and early postoperative recovery following primary total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Gonarthrosis; Primary, Total Knee Arthroplasty
- What is being tested?
- Routine perioperative management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 270 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2026to Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 50 to 80 years with a diagnosis of primary knee osteoarthritis who are scheduled to undergo elective primary total knee arthroplasty at Istanbul Sultangazi Haseki Training and Research Hospital. Eligible participants have an ASA physical status of I or II and are able to ambulate independently prior to surgery. All participants are capable of understanding the study procedures and providing written informed consent. Patients are managed according to the routine perioperative dexamethasone protocols of the surgeon selected by the patient. Group allocation is based on the standard clinical practice of the chosen surgeon and not assigned by the investigators. Participants are followed prospectively to evaluate postoperative pain, inflammatory response, functional mobility, postoperative nausea and vomiting, and analgesic requirements during the early postoperative period.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultangazi Haseki Training and Research Hospital
Istanbul, Istanbul, 34200
Atahan Eryilmaz, Resident Physician, +90552 609 9055, atahanerylmaz@yahoo.com
Mehmet Ersin, Associate Professor, +90 507 788 60 54, drmehmetersin@gmail.com
About this study
Official title: The Role of Dexamethasone in Total Knee Arthroplasty: Effects of Oral and Intravenous Administration on Early Postoperative Pain and Mobilization
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.
Read the detailed description
Total knee arthroplasty (TKA) is an effective treatment for advanced knee osteoarthritis; however, early postoperative recovery may be influenced by pain severity, limited functional mobility, systemic inflammatory response, metabolic alterations, and postoperative nausea and vomiting. Optimization of perioperative medical management is therefore a key component of enhanced recovery pathways.
Dexamethasone is frequently incorporated into perioperative care due to its anti-inflammatory, analgesic, antiemetic, and metabolic effects. Despite widespread use, variability persists in routine clinical practice regarding route of administration and dosing strategies. Comparative real-world data evaluating oral and intravenous administration within standardized care pathways remain limited.
This study is designed as a single-center, prospective observational cohort investigation evaluating early postoperative recovery parameters associated with routine perioperative dexamethasone strategies. The study does not introduce experimental interventions, randomization, or alterations to established treatment protocols.
Participants are assigned to cohorts according to the routine perioperative management approach of the operating surgeon selected by the patient. Each participating surgeon follows a predefined dexamethasone protocol that was implemented prior to initiation of this study. Treatment allocation is therefore independent of the research process and reflects real-world clinical practice.
The exposure of interest is perioperative dexamethasone administration as part of routine clinical care. Exposure status is defined according to the route of administration applied within the surgeon's established perioperative protocol: intravenous dexamethasone, oral dexamethasone, or no dexamethasone.
The standard institutional regimens consist of 8 mg administered preoperatively and 4 mg administered on postoperative day one, delivered either intravenously or orally depending on routine practice. Patients receiving no dexamethasone serve as the comparison cohort. Exposure classification is determined prior to postoperative outcome assessment.
All surgical procedures are performed using standardized institutional techniques for primary total knee arthroplasty. Postoperative management follows a multimodal analgesic protocol consistent across cohorts. Rescue opioid administration is provided when clinically indicated, and cumulative tramadol dose is recorded. Laboratory monitoring and clinical assessments are performed according to routine perioperative care standards.
Outcome data are collected prospectively using standardized and validated measurement tools during the early postoperative period. Baseline demographic and clinical variables are documented to account for potential confounding factors. Statistical analyses will include appropriate parametric or non-parametric tests depending on distributional assumptions. Repeated measurements will be evaluated using repeated-measures analysis or mixed-effects modeling, with multivariable adjustment to account for baseline differences between cohorts. Statistical significance is defined as p < 0.05.
The study is conducted in accordance with the Declaration of Helsinki and has received institutional ethics committee approval. All participants provide written informed consent prior to enrollment. Participation does not alter standard clinical management.
- Being tested
- Routine perioperative management
- Keywords
- Total Knee Arthroplasty, Intravenous Dexamethasone, Knee Osteoarthritis, Gonarthrosis, Multimodal Analgesia
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine perioperative managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Dexamethasone Group | Patients undergoing primary total knee arthroplasty who receive dexamethasone intravenously according to the routine perioperative protocol of the operating surgeon (8 mg IV preoperatively and 4 mg IV postoperatively). Receives: Other: Routine perioperative management | |
| Oral Dexamethasone Group | Patients undergoing primary total knee arthroplasty who receive dexamethasone orally according to the routine perioperative protocol of the operating surgeon (8 mg oral preoperatively and 4 mg oral postoperatively). Receives: Other: Routine perioperative management | |
| Control Group (No Dexamethasone) | Patients undergoing primary total knee arthroplasty who do not receive dexamethasone as part of the routine perioperative management. Receives: Other: Routine perioperative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Measured with Visiual Analog Scale (VAS)
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 0 to 10 numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity and therefore a worse outcome. Pain will be evaluated both at rest and during ambulation.
Measured: Measuring once in the preoperative period and every 6 hours during the first 48 hours after surgery.
Functional Mobility (Timed Up and Go Test)
Functional mobility will be evaluated using the Timed Up and Go (TUG) test, which measures the time (in seconds) required for a participant to stand up from a seated position, walk three meters, turn, walk back, and sit down. Shorter completion times indicate better functional mobility, whereas longer times indicate poorer performance.
Measured: Preoperatively and daily during the first 2 postoperative days.
Nausea and Vomiting (PONV) Score
Severity of postoperative nausea and vomiting will be assessed using a 0 to 10 Numeric Rating Scale (NRS), where 0 indicates no symptoms and 10 indicates the most severe nausea or vomiting imaginable. Higher scores represent worse symptoms.
Measured: Assessed daily during the first 2 postoperative days.
Postoperative Opioid Requirement
Requirement for rescue opioid analgesia following routine postoperative analgesic protocol consisting of scheduled paracetamol (4 doses per day) and NSAIDs (2 doses per day). Total opioid consumption and proportion of patients requiring opioid analgesia will be recorded. Cumulative tramadol dose administered as rescue analgesia will be recorded in milligrams (mg) during the first 48 hours after surgery. Higher values indicate greater postoperative analgesic requirement.
Measured: During the first 48 hours after surgery.
Secondary outcomes (5)
White Blood Cell Count
Systemic inflammatory response will be assessed by measuring white blood cell (WBC) count, expressed in ×10³/µL. Higher values indicate greater inflammatory response.
Measured: Preoperatively and daily during the first 2 postoperative days.
C-Reactive Protein Level
ystemic inflammatory response will also be assessed by measuring C-reactive protein (CRP) levels, expressed in mg/L. Higher values indicate greater inflammatory response.
Measured: Preoperatively and daily during the first 2 postoperative days.
Postoperative Glycemic Response
Serum blood glucose levels will be measured in mg/dL using standard hospital laboratory methods. Daily postoperative values will be recorded to evaluate metabolic response and potential dexamethasone-associated hyperglycemia. Higher values indicate increased glycemic response.
Measured: Preoperatively and daily during the first 2 postoperative days.
Knee Range of Motion - Flexion and Extension Angles
Knee range of motion will be measured in degrees (°) using a standard universal goniometer aligned with anatomical landmarks (greater trochanter, lateral femoral epicondyle, and lateral malleolus). Measurements will be performed by trained personnel following a standardized protocol to minimize inter-observer variability. Greater flexion angles indicate improved joint mobility, whereas higher extension deficit values indicate reduced extension capacity.
Measured: Preoperatively and daily during the first 2 postoperative days.
Postoperative Mobilization Status
Postoperative mobilization status will be assessed using a categorical (ordinal) scoring system at postoperative day 0, day 1, and day 2.
Patients will be classified into three categories based on their level of mobilization:
0 = Immobilized (no mobilization)
- = Independently mobilized (without assistance)
- = Assisted mobilization (with support) This classification is used to describe functional recovery status. Independent mobilization (score 1) represents the best functional outcome, assisted mobilization (score 2) represents moderate recovery, and immobilization (score 0) represents the poorest outcome.
All patient groups (intravenous dexamethasone, oral dexamethasone, and control) will be evaluated daily using this scale.
Measured: Postoperative Day 0, Day 1, and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start31 Mar 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ersin, Haseki Training and Research Hospital
- Investigators
- Mehmet Ersin, Associate Professor, Principal investigator, Sultangazi Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442812
- Sponsor's protocol ID
- 194-2025
- Acronym
- TKA
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies, patient privacy considerations, and the observational nature of this single-center study. The collected data are intended solely for the purposes of this research and related academic publications.
Publications
Chen J, He Y, Deng T, Li Y, Wang X, Zhao M, Li F, Wang C, Tian H. Effects of Dexamethasone on Nausea, Vomiting, and Inflammatory Indexes After Total Knee Arthroplasty. Orthop Surg. 2025 Oct;17(10):2862-2868. doi: 10.1111/os.70139. Epub 2025 Aug 13.
PubMed 40803755De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
PubMed 21799397Liang S, Xing M, Jiang S, Zou W. Effect of Intravenous Dexamethasone on Postoperative Pain in Patients Undergoing Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. Pain Physician. 2022 Mar;25(2):E169-E183.
PubMed 35322969Xu B, Ma J, Huang Q, Huang ZY, Zhang SY, Pei FX. Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. Knee Surg Sports Traumatol Arthrosc. 2018 May;26(5):1549-1556. doi: 10.1007/s00167-017-4506-x. Epub 2017 May 4.
PubMed 28474088Chan TCW, Cheung CW, Wong SSC, Chung AYF, Irwin MG, Chan PK, Fu H, Yan CH, Chiu KY. Preoperative dexamethasone for pain relief after total knee arthroplasty: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1157-1167. doi: 10.1097/EJA.0000000000001372.
PubMed 33105245