Hyaluronic Acid, Trigger Finger
Conditions
Brief summary
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
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.
Interventions
DEVICEHyaluronic acid (HA)
Hyaluronic acid (HA)
DEVICESaline
Saline
Sponsors
SciVision Biotech Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Agree to participate in this study and sign informed consent form 2. Age 20 to 65 years of male or female 3. The trigger finger, except thumb, classified as 3 to 4 points and plan to conduct trigger finger release surgery; 4. The trigger finger, except thumb, classified as 2 points with the symptom of flexion contracture and plan to conduct trigger finger release surgery; 5. Agree to comply with the follow-up schedule of this study
Exclusion criteria
1. Target finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, compression injury or other disease; 2. Other fingers in the same hand as the target finger have other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury; 3. Contralateral finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury; 4. The operation site was conducted tendon transplantation or any surgery in past 6 months; 5. Receiving orthopedic-related treatment which may affect the evaluation of the study; 6. The skin of the operation site with infection, deficiency, or needing skin transplantation; 7. With poorly controlled chronic diseases, such as diabetes mellitus; 8. 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; 9. 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.); 10. With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or taking blood circulation promotion and blood stasis removement medications within the past 10 days; 11. 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; 12. Pregnant, planning pregnancy or in breastfeeding females; 13. Other circumstances which judged to be unsuitable for participating in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of Total Active Motion (TAM) score for target finger. | 30 days post-operation | The percentage of Total Active Motion (TAM) score for target finger at 30 days post-operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TAM score of target finger. | baseline, 14, 30, 60, 90, and 180 days post-operation | TAM score of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation. |
| The grade of TAM score of target finger and contralateral finger. | baseline, 14, 30, 60, 90, and 180 days post-operation | The grade of TAM score of target finger and contralateral 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. | 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' |
| The percentage of TAM score of target finger. | baseline, 14, 60, 90, and 180 days post-operation | The percentage of TAM score of target finger at baseline, 14, 60, 90, and 180 days post-operation. |
| The evaluation of tendon by sonography. | baseline, 14, 30, 60, 90, and 180 days post-operation | The evaluation of tendon by sonography at baseline, 14, 30, 60, 90, and 180 days post-operation. |
| Subjects self-evaluating Visual Analogue Scale (VAS) in satisfaction | 14, 30, 60, 90, and 180 days post-operation | 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'. |
| The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE). | baseline, 14, 30, 60, 90, and 180 days post-operation | The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE). |
| Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash). | baseline, 14, 30, 60, 90, and 180 days post-operation | 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. |
Countries
Taiwan
Outcome results
None listed