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

Trigger Finger Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05082480
• Other study ID #: RDCT-TWDH
• Status: Terminated
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: April 28, 2023

Study information

• Verified date: May 2022
• Source: SciVision Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyaluronic Acid
• Trigger Finger
• Trigger Finger Disorder

Intervention

Device:
• Hyaluronic acid (HA)
Hyaluronic acid (HA)
• Saline
Saline

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Municipal Ta-Tung Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
SciVision Biotech Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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