To Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery

Launched by TALENT CRO INC. · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called crosslinking hyaluronan hydrogel, which is being tested to see if it can help prevent adhesions (scar tissue) from forming after surgery to repair the anterior talofibular ligament in the ankle. The goal is to see if this treatment can improve how well patients can move their ankles after surgery compared to those who do not receive the hydrogel.

To participate in this trial, you need to be between 18 and 60 years old and have been experiencing pain from a ligament injury in your ankle, confirmed by an MRI. You should also have a history of repeated ankle sprains that haven’t improved with other treatments and be scheduled for surgery. If you join the trial, you will receive the hydrogel treatment during your surgery and will be monitored afterward to see how well your ankle heals. It’s important to know that certain health conditions or medications may disqualify you from participating, so please discuss this with your doctor if you think you might be interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1.1 Voluntarily participate and sign an informed consent form; 1.2 Age 18 to 60 years of male or female; 1.3 Patients experiencing lateral ankle pain discomfort, confirmed by MRI to have anterior talofibular ligament (ATFL) injury; 1.4 History of recurrent ankle inversion sprains three times or more, with no improvement after six months of conservative treatment, and scheduled for ATFL repair surgery; 1.5 Willing to comply with all follow-up requirements of the trial protocol.
• Exclusion Criteria:
• • 2.1 Severe ankle osteoarthritis; 2.2 Patients with a history of ankle fracture or surgery; 2.3 Undergoing foot- or ankle-related treatments that may affect the trial results; 2.4 Presence of skin infection, skin defects, or need for skin grafting at the surgical site; 2.5 Uncontrolled chronic diseases, such as diabetes mellitus; 2.6 Presence of autoimmune diseases (such as Autoimmune Collagenopathy, rheumatoid arthritis), malignancies, coagulation disorders, heart diseases, psychiatric illnesses, or other conditions that may pose higher risks to patients in the trial; 2.7 Use of corticosteroids within the past 6 months, systemic corticosteroids within the past month, immunosuppressive drugs within the past 3 months, or daily use of non-steroidal anti-inflammatory drugs (NSAIDs) within the past week, or occasional use within 8 hours (patients using nasal/inhaled corticosteroids may be considered for inclusion) ; 2.8 Clinically significant coagulation abnormalities or undergoing anticoagulant therapy within 10 days before surgery or currently taking anticoagulant drugs; 2.9 Known allergy to sodium hyaluronate or any components of medical devices;allergy to Gram-positive bacterial protein or streptococcal protein；or other severe allergic history deemed unsuitable for participation by the investigators; 2.10 Pregnant, lactating women, or women planning to become pregnant during the trial period; 2.11 Other conditions deemed unsuitable for participation by the investigators.