BridgeMD
Compares treatment options for Total Knee Replacement
Official title A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
ClinicalTrials.gov ID: NCT04432012
What this study is testing
What is Dexamethasone Sodium Phosphate 4 mg/ml intravenous?
Dexamethasone Sodium Phosphate 4 mg/ml intravenous is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for total knee replacement.
Also referred to as Mephameson.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- 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).
You likely can't join if
- 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
See the full eligibility criteria
- 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).
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lugano, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lugano, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.