Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hyaluronic acid (HA) Hyaluronic acid (HA) |
Device: Hyaluronic acid (HA)
Hyaluronic acid (HA)
|
| Placebo Comparator: Saline Saline |
Device: Saline
Saline
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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'
- 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.
- 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).
Eligibility Criteria
Criteria
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;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | Taiwan | ||
| 2 | Kaohsiung Municipal Ta-Tung Hospital | Kaohsiung | Taiwan |
Sponsors and Collaborators
- SciVision Biotech Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RDCT-TWDH