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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe
conventional therapy without using any antiadhesion product
Show Chwan Memorial Hospital
Changhua, Taiwan
RECRUITINGRange of Motion (ROM)
Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.
Time frame: day 14
Range of Motion (ROM)
Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.
Time frame: 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.
Time frame: 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'
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: baseline, day 14, 28, 49, 70
Subject self-assessment satisfaction scores
Subject self-assessment satisfaction scores
Time frame: day 14, 28, 49, 70
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