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

Talent Cro Inc.

Status: Enrolling

Conditions: Anterior Talofibular Ligament Injury

Treatments: Device: Sham (No Treatment); Device: DEFEHERE Absorbable Adhesion Barrier

Study type: Interventional

Funder types: Other

Identifiers

NCT06826898

RDCT-SCDH

Details and patient eligibility

About

The goal of this clinical trial is 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. With applying crosslinking hyaluronan hydrogel, the range of motion (ROM) of the ankle is expected to be better than sham group.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Absorbable Adhesion Barrier

Experimental group

Description:

DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe

Treatment:

Device: DEFEHERE Absorbable Adhesion Barrier

Sham

Sham Comparator group

Description:

conventional therapy without using any antiadhesion product

Treatment:

Device: Sham (No Treatment)