Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Prospective, Double-Centre, Randomized, Evaluator/Subject-blinded, Control Clinical Study: 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

Conditions
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Trigger Finger, Hyaluronic Acid

Intervention / Treatment
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* Device: Hyaluronic acid (HA)
* Device: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agree to participate in this study and sign informed consent form Age 20 to 65 years of male or female The trigger finger, except thumb, classified as 3 to 4 points and plan to conduct trigger finger release surgery; The trigger finger, except thumb, classified as 2 points with the symptom of flexion contracture and plan to conduct trigger finger release surgery; Agree to comply with the follow-up schedule of this study Exclusion Criteria: Target finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, compression injury or other disease; Other fingers in the same hand as the target finger have other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury; Contralateral finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury; The operation site was conducted tendon transplantation or any surgery in past 6 months; Receiving orthopedic-related treatment which may affect the evaluation of the study; The skin of the operation site with infection, deficiency, or needing skin transplantation; With poorly controlled chronic diseases, such as diabetes mellitus; Patient with autoimmune disease (such as rheumatoid arthritis), malignant tumors, coagulation diseases, heart diseases, mental diseases, etc., may cause patients to participate in the trial at higher risk; Patient who has taken cortisol within the past 6 months, systemic corticosteroids within the past 2 months, immunosuppressive drugs within past 3 months, or non-steroidal anti-inflammatory drugs (NSAIDs) everyday within 1 week or NSAIDs within 8 hours occasionally. (subjects who have received inhaled/intranasal corticosteroids could be considered to include.); With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or taking blood circulation promotion and blood stasis removement medications within the past 10 days; With history of hypersensitivity or allergy to hyaluronic acid or any component of the device; With history of hypersensitivity or allergy to Gram-positive bacteria or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study; Pregnant, planning pregnancy or in breastfeeding females; Other circumstances which judged to be unsuitable for participating in the study by the investigator.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid (HA)<br>Hyaluronic acid (HA) | Device: Hyaluronic acid (HA)<br>* Hyaluronic acid (HA)<br>|
| Placebo Comparator: Saline<br>Saline | Device: Saline<br>* Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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' | 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. | 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. | 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'. | 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). | baseline, 14, 30, 60, 90, and 180 days post-operation |