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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absorbable Adhesion Barrier | Experimental | DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe |
|
| Sham | Sham Comparator | conventional therapy without using any antiadhesion product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEFEHERE Absorbable Adhesion Barrier | Device | DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion (ROM) | Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle. | day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion (ROM) | Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle. | baseline, day 28, 49, 70 |
| Anterior Talar Translation (ATT) | On the sagittal plane, the talus below the tibia will be pulled forward to test the integrity of the anterior talofibular ligament. |
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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 proteinï¼›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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan-Yu Chen Doctor | Contact | +88647684326 | swallowfish@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Show Chwan Memorial Hospital | Recruiting | Changhua | Taiwan |
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| Sham (No Treatment) | Device | conventional therapy without using any antiadhesion product |
|
| baseline, day 14, 28, 49, 70 |
| Visual Analogue Scale (VAS) for pain | The VAS scale uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain' | baseline, day 14, 28, 49, 70 |
| Cumberland Ankle Instability Tool (CAIT) questionnaire | The Cumberland Ankle Instability Tool (CAIT) is a 9-item 30-point scale that measures the severity of functional ankle instability. | baseline, day 14, 28, 49, 70 |
| American Orthopedic Foot and Ankle Society (AOFAS) questionnaire | AOFAS includes 9 items that can be divided into three subscales (pain, function and alignment). | baseline, day 14, 28, 49, 70 |
| Foot and Ankle Ability Measure (FAAM) questionnaire | A self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The FAAM is a 31-item questionnaire divided into two subscales: Activities of Daily Living Subscale and Sports Subscale. | baseline, day 14, 28, 49, 70 |
| Subject self-assessment satisfaction scores | Subject self-assessment satisfaction scores | day 14, 28, 49, 70 |