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

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

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 Overview

• Status: Terminated
• Conditions: Trigger Finger; Hyaluronic Acid
• Intervention / Treatment: Device: Hyaluronic acid (HA); Device: Saline

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yin-Chih Fu, MD-PhD; Phone Number: 5751 +886-7-3121101; Email: microfu@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung, Taiwan
    • Kaohsiung Municipal Ta-Tung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline	Device: Saline; Saline
Experimental: Hyaluronic acid (HA)	Device: Hyaluronic acid (HA); Hyaluronic acid (HA)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SciVision Biotech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Trigger Finger Disorder; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: RDCT-TWDH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No