A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
NCT ID: NCT04432012
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
159 participants
INTERVENTIONAL
2020-07-01
2033-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dexamethasone in Total Knee and Total Hip Arthroplasty
NCT02760043
Steroids in Total Knee Arthroplasty
NCT02219581
Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty
NCT07337772
Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?
NCT00492973
Evaluation of the Effect of Triamcinolone at Different Doses on LIA During TKA
NCT05997238
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
arm-A Intra-venous dexamethasone
9 mg of Intra-venous dexamethasone
Dexamethasone Sodium Phosphate 4 mg/ml intravenous
Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)
arm-B intra-articular dexamethasone
9 mg of intra-articular dexamethasone
Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)
arm-C routine
No steroid supplementation or other drugs will be added to the routinely performed anaesthesia protocol in the control group
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexamethasone Sodium Phosphate 4 mg/ml intravenous
Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)
Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
Exclusion Criteria
* 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
* 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.
50 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Christian Candrian
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christian Candrian
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christian Candrian, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
EOC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedale Regionale di Lugano Civico e Italiano
Lugano, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ORL-ORT-013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.