Anterior Talofibular Ligament Injury
Conditions
Brief summary
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.
Interventions
DEVICEDEFEHERE Absorbable Adhesion Barrier
DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe
DEVICESham (No Treatment)
conventional therapy without using any antiadhesion product
Sponsors
Talent Cro Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion (ROM) | day 14 | Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Talar Translation (ATT) | baseline, day 14, 28, 49, 70 | On the sagittal plane, the talus below the tibia will be pulled forward to test the integrity of the anterior talofibular ligament. |
| Visual Analogue Scale (VAS) for pain | baseline, day 14, 28, 49, 70 | The VAS scale uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain' |
| Cumberland Ankle Instability Tool (CAIT) questionnaire | baseline, day 14, 28, 49, 70 | The Cumberland Ankle Instability Tool (CAIT) is a 9-item 30-point scale that measures the severity of functional ankle instability. |
| Range of Motion (ROM) | baseline, day 28, 49, 70 | Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle. |
| Foot and Ankle Ability Measure (FAAM) questionnaire | baseline, day 14, 28, 49, 70 | 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. |
| Subject self-assessment satisfaction scores | day 14, 28, 49, 70 | Subject self-assessment satisfaction scores |
| American Orthopedic Foot and Ankle Society (AOFAS) questionnaire | baseline, day 14, 28, 49, 70 | AOFAS includes 9 items that can be divided into three subscales (pain, function and alignment). |
Countries
Taiwan
Contacts
Primary ContactYan-Yu Chen Doctor
Outcome results
None listed