BridgeMD
Efficacy of peri-operative dexamethasone administration in single bundle anterior cruciate ligament reconstruction: a prospective randomized double-blinded placebo-controlled trial
EU CTIS ID: 2024-511559-17-00
What this study is testing
To compare the effect of perioperative dexamethasone administration versus saline solution administration on postoperative pain after single-bundle anterior cruciate ligament reconstruction
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants willing and able to sign informed consent for participation in the study
- Male and female, aged between 18 and 45 years old
- Patients without comorbidities
- Ability to take oral medication during the follow up, including analgesic, antiemetics and opioids
- Females in reproductive age: GRAVINDEX (agglutination inhibition test performed on a urine sample to detect pregnancy, based on double antigen antibody reaction) will be performed before surgery to exclude eventually pregnant women. Women taking oral contraceptive or using other methods of contraception can be included.
- Males in reproductive age will be included
You likely can't join if
- Active viral and bacterial infections
- Rheumatic diseases
- Peptic ulcer
- Diabetes
- Multi-ligament Injuries
- Age < 18 years and > 45 years
See the full eligibility criteria
- Participants willing and able to sign informed consent for participation in the study
- Male and female, aged between 18 and 45 years old
- Patients without comorbidities
- Ability to take oral medication during the follow up, including analgesic, antiemetics and opioids
- Females in reproductive age: GRAVINDEX (agglutination inhibition test performed on a urine sample to detect pregnancy, based on double antigen antibody reaction) will be performed before surgery to exclude eventually pregnant women. Women taking oral contraceptive or using other methods of contraception can be included.
- Males in reproductive age will be included
- Confirmed diagnosis of complete anterior cruciate ligament rupture, confirmation is achieved through clinical diagnostic tests.
- Patients undergoing single-bundle anterior cruciate ligament (ACL) reconstruction using an autograft (gracilis or semitendinosus tendon) with the ULTRABUTTON™ Adjustable Fixation technique will be included in the study
- Active viral and bacterial infections
- Rheumatic diseases
- Peptic ulcer
- Diabetes
- Multi-ligament Injuries
- Age < 18 years and > 45 years
- Knee Osteoarthritis
- Patients with severe cartilage damage
- Previous Surgery or fractures on the affected knee
- Kidney diseases (GRF < 90 ml/min)
- History of thrombosis
- Allergy or hypersensitivity to any component of the IMP (dexamethasone), including excipients
- Drug contraindication: bacterial and fungal infections, peptic ulcers, psychosis, ocular herpes simplex virus infection, local injection in infected sites, local injection in unstable joints
- Chronic steroid use
- Pregnant and/or breastfeeding women
- Ongoing immunosuppressive therapies
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.