To Evaluate the Effectiveness of the use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Trigger Finger Release Surgery
The medical device is a bioabsorbable, extensible, crosslinked, 6% hyaluronic acid gel using fermentation sourced hyaluronic acid as a major component. This product could perfectly attach to the tissue surface, creating anti-adhesion layer which avoids post-surgical adhesion and is completely resorbed over time. This study is aimed to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after trigger finger release surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
5
Hyaluronic acid (HA)
Saline
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Municipal Ta-Tung Hospital
Kaohsiung City, Taiwan
The percentage of Total Active Motion (TAM) score for target finger.
The percentage of Total Active Motion (TAM) score for target finger at 30 days post-operation.
Time frame: 30 days post-operation
The percentage of TAM score of target finger.
The percentage of TAM score of target finger at baseline, 14, 60, 90, and 180 days post-operation.
Time frame: baseline, 14, 60, 90, and 180 days post-operation
TAM score of target finger.
TAM score of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation.
Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation
The grade of TAM score of target finger and contralateral finger.
The grade of TAM score of target finger and contralateral finger at baseline, 14, 30, 60, 90, and 180 days post-operation
Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation
Subjects self-evaluating Visual Analogue Scale (VAS) in pain of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation.
Subjects self-evaluating Visual Analogue Scale (VAS) in pain of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'
Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation
Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash).
Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash) at baseline, 14, 30, 60, 90, and 180 days post-operation.
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Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation
The evaluation of tendon by sonography.
The evaluation of tendon by sonography at baseline, 14, 30, 60, 90, and 180 days post-operation.
Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation
Subjects self-evaluating Visual Analogue Scale (VAS) in satisfaction
Subjects self-evaluating satisfaction at 14, 30, 60, 90, and 180 days post-operation. Patients rate their treatment satisfaction based on a 100 mm VAS. The VAS scale uses a 100 mm line labelled at '0' with 'least satisfaction' and '100' with 'highest satisfaction'.
Time frame: 14, 30, 60, 90, and 180 days post-operation
The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE).
The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE).
Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation