A Phase 4 interventional study of Dexamethasone Sodium Phosphate 4 mg/ml intravenous and Dexamethasone Sodium Phosphate 4 mg/ml intra-articular in Total Knee Replacement, sponsored by Christian Candrian. Recruiting at 1 site in Switzerland. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Christian Candrian · Phase 4, Interventional, and Treatment
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We are going to evaluate the difference between perioperative intravenous steroid supplementation, perioperative periarticular steroid supplementation, and standard anaesthesia protocols. We'll evaluate the outcome of patients with knee osteoarthritis who are undergoing Total Knee Arthroplasty to understand which of the three treatments give more benefits to the patient.
A total of 159 patients will be needed (53 patients per arm, 3 arms in total). Dexamethasone (brand name: Mephameson) is the steroid drug that we perioperative administer in two different ways: intra-venous (IV) dexamethasone (9mg) in arm-A, intra-articular (IA) dexamethasone (9mg) in arm-B. No steroid supplementation will be provided in the control group (arm-C).
The primary objective of the study is to compare the effect on post-operative pain of I.V. and I.A. perioperative dexamethasone supplementation for total knee arthroplasty (TKA).
The secondary objectives of the studies will be the comparison between I.V. and I.A. peri-operative dexamethasone supplementation in terms of post-operative pain and function, opioids and analgesic drugs consumption, knee range of motion, systemic inflammatory response, time to mobilisation, length of stay, and patient satisfaction.
Moreover, both I.V. and I.A. steroid supplementation protocols will be compared to routine analgesia protocol (no steroid supplementation group) in order to document their advantages over the absence of steroid supplementation.
The safety of I.V. and I.A. peri-operative dexamethasone will be evaluated and compared recording all the steroid supplementation related complications. In particular, the risk of hyperglycaemia-related complications and post-operative infections will be documented. The safety of both I.V. and I.A. steroid supplementation protocols will be verified comparing them to the no-treatment group in terms of incidence of complications.
Overall study duration will be 12 years: 2 years to enroll all the patients and 10 years to complete the last follow-up. Primary data analysis is planned after the completion of the 1-year follow-up visits.
Christian Candrian is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
9 mg of Intra-venous dexamethasone
Drug: Dexamethasone Sodium Phosphate 4 mg/ml intravenous
9 mg of intra-articular dexamethasone
Drug: Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
No steroid supplementation or other drugs will be added to the routinely performed anaesthesia protocol in the control group
Drug page: Dexamethasone phosphate
Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)
Also known as: Mephameson
Drug page: Dexamethasone phosphate
Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)
Also known as: Mephameson
Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale
Mean daily pain at rest during the first 3 days reported on a 0-10 numeric rating scale (NRS) by the patients. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.
Time frame: 3 days after surgery
Post-operative knee pain during the first 6 weeks after surgery on a 0-10 numeric rating scale
Pain reported on 0-10 numeric rating scale (NRS) during the first 6 weeks and documented with a mobile application (developed at our Institution) that will ask the patients to report pain twice a day (once in the morning, once in the evening). Comparison will be performed in terms of mean daily pain during the first 6 weeks and mean daily pain during every single week. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.
Time frame: 6 weeks after surgery
Post-operative knee pain during the first 10 years after surgery
reported on 0-10 NRS at 3, 6, 12, 24, 60 and 120 months using a questionnaire. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.
Time frame: 10 years
Post-operative function during the first 6 weeks after surgery
reported on 0-10 NRS 8see above) during the first 6 weeks, documented with a mobile application developed by our institution that will ask the patients to report pain twice a day (once in the morning, once in the evening). Comparison will be performed in terms of mean daily pain during the first 6 weeks and mean daily pain during every single week. Furthermore, pain trajectories will be created. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating the worst possible function and 10 reflecting the best possible function.
Time frame: 6 weeks
Post-operative knee function during the first 10 years after surgery
reported on 0-10 NRS at 3, 6, 12, 24, 60 and 120 months using a questionnaire. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating the worst possible function and 10 reflecting the best possible function.
Time frame: 10 years
Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. The WOMAC questionnaire is composed of 3 sub-scores that evaluate pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points), and function (17 questions, 0-68 points) and is a validated patient-reported outcome measure (PROM) to evaluate knee osteoarthritis. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: 10 years
Knee conditions on Knee society score (KSS)
Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Time frame: 10 years
Quality of pain on PainDETECT questionnaire
Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. PainDETECT consists of seven questions that address the quality of pain symptoms; it is completed by the patient and no physical examination is required. A score ≤12 indicates that pain is unlikely to have a neuropathic component (\< 15%), while a score of ≥19 suggests that pain is likely to have a neuropathic component (\> 90%). An intermediate score (≥13, ≤18) indicates a possible neuropathic component .
Time frame: 10 years
Patient satisfaction: numeric rating scale (NRS)
Patient satisfaction reported on 0-10 numeric rating scale (NRS) at 3, 6, 12, 24, 60 and 120 months using a questionnaire. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating that patient is not satisfied at all and 10 reflecting that patient is totally satisfied.
Time frame: 10 years
Post-operative nausea incidence
incidence (on a 0-10 NRS) of nausea will be evaluated in the first post-operative days. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the maximum intensity of nausea.
Time frame: During Hospitalization, approximately 3 days
Post-operative nausea intensity
intensity (on a 0-10 NRS) of nausea will be evaluated in the first post-operative days. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the maximum intensity of nausea.
Time frame: During Hospitalization, approximately 3 days
Post-operative opioids and analgesic drugs consumption
Medication Quantification Scale (MQS) score will be used to evaluate analgesic drug consumption. Medication Quantification Scale (MQS) scor is calculated for each medication by taking a consensus-based detriment weight for a given pharmacologic class and multiplying it by a score for dosage. The calculated values for each medication are then summed for a total MQS score. The score can provide a useful point measure of medication usage for any pain medication regimen.
Time frame: During Hospitalization, approximately 3 days
Post-operative C-Reactive Protein (CRP)
Hematic C-Reactive Protein in mg/L will be evaluated as index of post-operative inflammatory response.
Time frame: every days 3 days from surgery
Post-operative erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate (mm/h) will be evaluated as index of post-operative inflammatory response.
Time frame: every days 3 days from surgery
Time from surgery to first mobilization
Time frame: During Hospitalization, approximately 1 days
Time needed for climbing stairs the first time
Time frame: approximately 1 week
Length of hospital stay
Time frame: approximately 1 week
Number of patients with treatment-related adverse events
The safety of I.V. and I.A. dexamethasone supplementation will be evaluated in terms of: rate of serious adverse events related to steroid supplementation, rate of prosthetic joint infections, rate of wound infections, rate of wound healing problems. Furthermore, glycaemia will be evaluated daily during the first three days after surgery. To delineate a complete safety profile of dexamethasone supplementation, all treatment related adverse events will be reported.
Time frame: 10 years
Plan to share: No — not foreseen
No publications or documents are linked to this record.
Started Jul 2020 (actual). Primary completion is estimated for Apr 2027, 81 months after the start.
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Studies of the drug tested here: Dexamethasone phosphate
Christian Candrian