Total Knee ReplacementPhase 4NCT04432012
A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
A Phase 4 study testing Dexamethasone Sodium Phosphate 4 mg/ml intravenous and Dexamethasone Sodium Phosphate 4 mg/ml intra-articular in people with Total Knee Replacement, run by Christian Candrian at 1 site in Switzerland.
Trial summary
We are going to evaluate the difference between perioperative intravenous steroid supplementation, perioperative periarticular steroid supplementation, and standard anaesthesia protocols. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Dexamethasone Sodium Phosphate 4 mg/ml intravenous and Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 30 Apr 2033
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral primary TKA at the Ospedale Regionale di Lugano.
- Patients with a BMI >18.5 and <35.
- Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Who cannot join
- Contraindications to steroids.
- Revision TKA.
- Active steroid therapy.
- Women who are pregnant or breast feeding.
- Presence of other clinically significant concomitant disease states (ASA IV).
- Uncontrolled diabetes mellitus
Show all 11Show fewer
- Known or suspected non-compliance, drug or alcohol abuse.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
- Previous enrolment into the current study.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Ospedale Regionale di Lugano Civico e Italiano
Lugano, 6900
Christian Candrian, MD, Prof, +41 (0)91 811 7029, christian.candrian@eoc.ch
About this study
Official title: Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs no Steroid Supplementation in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis - A Randomized Controlled Trial Clinical Study Protocol
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.
Read the detailed description
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.
- Conditions
- Total Knee Replacement
- Being tested
- Dexamethasone Sodium Phosphate 4 mg/ml intravenous, Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
- Keywords
- Knee, surgery, replacement, arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Sodium Phosphate 4 mg/ml intravenousDrug
Also called Mephameson
Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)
Dexamethasone Sodium Phosphate 4 mg/ml intra-articularDrug
Also called Mephameson
Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)
| Study group | Role | What they receive |
|---|---|---|
| arm-A Intra-venous dexamethasone | Experimental | 9 mg of Intra-venous dexamethasone Receives: Drug: Dexamethasone Sodium Phosphate 4 mg/ml intravenous |
| arm-B intra-articular dexamethasone | Experimental | 9 mg of intra-articular dexamethasone Receives: Drug: Dexamethasone Sodium Phosphate 4 mg/ml intra-articular |
| arm-C routine | No intervention | No steroid supplementation or other drugs will be added to the routinely performed anaesthesia protocol in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days after surgery
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: every days 3 days from surgery
Time from surgery to first mobilization
Measured: During Hospitalization, approximately 1 days
Time needed for climbing stairs the first time
Measured: approximately 1 week
Length of hospital stay
Measured: approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jul 2020
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Candrian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Candrian, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Christian Candrian, MD, Prof., Principal investigator, EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432012
- Sponsor's protocol ID
- ORL-ORT-013
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2020
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not foreseen
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs no Steroid Supplementation in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis - A Randomized Controlled Trial Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT04432012
- Acronym / sponsor ID
- ORL-ORT-013
- Conditions
- Total Knee Replacement
- Keywords
- Knee, surgery, replacement, arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Christian CandrianUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2033 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arm-A Intra-venous dexamethasone | Experimental | Drug: Dexamethasone Sodium Phosphate 4 mg/ml intravenous9 mg of Intra-venous dexamethasone |
| arm-B intra-articular dexamethasone | Experimental | Drug: Dexamethasone Sodium Phosphate 4 mg/ml intra-articular9 mg of intra-articular dexamethasone |
| arm-C routine | No intervention | –No steroid supplementation or other drugs will be added to the routinely performed anaesthesia protocol in the control group |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing unilateral primary TKA at the Ospedale Regionale di Lugano.
- Patients with a BMI >18.5 and <35.
- Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Key exclusion criteria (11 listed)
- Contraindications to steroids.
- Revision TKA.
- Active steroid therapy.
- Women who are pregnant or breast feeding.
- Presence of other clinically significant concomitant disease states (ASA IV).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Sodium Phosphate 4 mg/ml intravenousAlso: MephamesonPerioperative intravenous injection of 3 ml of solution (9mg of dexamethasone) | Drug | arm-A Intra-venous dexamethasone |
| Dexamethasone Sodium Phosphate 4 mg/ml intra-articularAlso: MephamesonPerioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone) | Drug | arm-B intra-articular dexamethasone |
Primary outcome
Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale
Time frame: 3 days after surgery
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.
16 secondary outcomes
Post-operative knee pain during the first 6 weeks after surgery on a 0-10 numeric rating scale
Time frame: 6 weeks after surgery
Post-operative knee pain during the first 10 years after surgery
Time frame: 10 years
Post-operative function during the first 6 weeks after surgery
Time frame: 6 weeks
Post-operative knee function during the first 10 years after surgery
Time frame: 10 years
Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 10 years
Knee conditions on Knee society score (KSS)
Time frame: 10 years
Quality of pain on PainDETECT questionnaire
Time frame: 10 years
Patient satisfaction: numeric rating scale (NRS)
Time frame: 10 years
Post-operative nausea incidence
Time frame: During Hospitalization, approximately 3 days
Post-operative nausea intensity
Time frame: During Hospitalization, approximately 3 days
Post-operative opioids and analgesic drugs consumption
Time frame: During Hospitalization, approximately 3 days
Post-operative C-Reactive Protein (CRP)
Time frame: every days 3 days from surgery
Post-operative erythrocyte sedimentation rate (ESR)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. not foreseen
Related trials for Total Knee Replacement
Not yet recruiting
Application of Perinatal Derivatives in Total Knee Arthroplasty
Total Knee Arthroplasty, Knee Osteoarthristis
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Candrian, MD, Prof. principal investigator
EOC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Sodium Phosphate 4 mg/ml intravenous and Dexamethasone Sodium Phosphate 4 mg/ml intra-articular in people with Total Knee Replacement, run by Christian Candrian at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Candrian, MD, Prof (+41 (0) 91 811 61 23, christian.candrian@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale (time frame: 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.