DEXAMETHASONE SODIUM PHOSPHATE for Anterior cruciate ligament rupture | Anterior cruciate ligament reconstruction

Inclusion criteria

• {"criterion_text":"- Participants willing and able to sign informed consent for participation in the study\n- Male and female, aged between 18 and 45 years old\n- Patients without comorbidities\n- Ability to take oral medication during the follow up, including analgesic, antiemetics and opioids\n- 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.\n- Males in reproductive age will be included\n- Confirmed diagnosis of complete anterior cruciate ligament rupture, confirmation is achieved through clinical diagnostic tests.\n- 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"}

Exclusion criteria

• {"criterion_text":"- Active viral and bacterial infections\n- Rheumatic diseases\n- Peptic ulcer\n- Diabetes\n- Multi-ligament Injuries\n- Age < 18 years and > 45 years\n- Knee Osteoarthritis\n- Patients with severe cartilage damage\n- Previous Surgery or fractures on the affected knee\n- Kidney diseases (GRF < 90 ml/min)\n- History of thrombosis\n- Allergy or hypersensitivity to any component of the IMP (dexamethasone), including excipients\n- Drug contraindication: bacterial and fungal infections, peptic ulcers, psychosis, ocular herpes simplex virus infection, local injection in infected sites, local injection in unstable joints\n- Chronic steroid use\n- Pregnant and/or breastfeeding women\n- Ongoing immunosuppressive therapies"}

Primary endpoints

• {"endpoint_text":"- Pain levels will be measured by VAS from participants in each treatment arm at rest and during walking","definition_or_measurement_approach":"Measurement: Visual Analog Scale (VAS) assessments at rest and during walking for participants in each treatment arm"}

Secondary endpoints

• {"endpoint_text":"- Pain levels with VAS from participants in each treatment arm at rest and during walking The number of episodes of nausea and vomiting will be recorded from participants in each treatment arm.","definition_or_measurement_approach":"Measurement: VAS for pain at rest and during walking; recording the number of episodes of nausea and vomiting per participant in each arm"}
• {"endpoint_text":"- Functional scores (range of movement, length of stay, and earlier return to activity of daily life evaluated in terms of walking with crutches in the days after surgery without invalidating pain) will be evaluated in patients in the control group versus study group. Number of patients who experience surgical site infection and complications (fever, wound infections, delayed tissue healing and gastrointestinal bleeding)","definition_or_measurement_approach":"Measurement: functional scores including range of movement, length of hospital stay, time to return to activities of daily life (e.g., walking with crutches); record incidence of surgical site infections and specified complications"}

Italy

Earliest CTIS Part Ii Submission Date

05-11-2024

Latest Decision Or Authorization Date

17-12-2024

Processing Time Days

42

Number Of Sites

1

Number Of Participants

88

Primary sponsor

Full Name

Ospedale San Raffaele S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy