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

Primary Purpose

Trigger Finger, Hyaluronic Acid

Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hyaluronic acid (HA)
Saline
Sponsored by
SciVision Biotech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trigger Finger

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hyaluronic acid (HA)

Saline

Arm Description

Hyaluronic acid (HA)

Saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
TAM score of target finger.
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.
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.
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).
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.
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
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).
The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE).

Full Information

First Posted
October 5, 2021
Last Updated
May 10, 2023
Sponsor
SciVision Biotech Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05082480
Brief Title
Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
poor enrollment
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciVision Biotech Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger, Hyaluronic Acid

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid (HA)
Arm Type
Experimental
Arm Description
Hyaluronic acid (HA)
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid (HA)
Intervention Description
Hyaluronic acid (HA)
Intervention Type
Device
Intervention Name(s)
Saline
Intervention Description
Saline
Primary Outcome Measure Information:
Title
The percentage of Total Active Motion (TAM) score for target finger.
Description
The percentage of Total Active Motion (TAM) score for target finger at 30 days post-operation.
Time Frame
30 days post-operation
Secondary Outcome Measure Information:
Title
The percentage of TAM score of target finger.
Description
The percentage of TAM score of target finger at baseline, 14, 60, 90, and 180 days post-operation.
Time Frame
baseline, 14, 60, 90, and 180 days post-operation
Title
TAM score of target finger.
Description
TAM score of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation.
Time Frame
baseline, 14, 30, 60, 90, and 180 days post-operation
Title
The grade of TAM score of target finger and contralateral finger.
Description
The grade of TAM score of target finger and contralateral finger at baseline, 14, 30, 60, 90, and 180 days post-operation
Time Frame
baseline, 14, 30, 60, 90, and 180 days post-operation
Title
Subjects self-evaluating Visual Analogue Scale (VAS) in pain of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation.
Description
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'
Time Frame
baseline, 14, 30, 60, 90, and 180 days post-operation
Title
Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash).
Description
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.
Time Frame
baseline, 14, 30, 60, 90, and 180 days post-operation
Title
The evaluation of tendon by sonography.
Description
The evaluation of tendon by sonography at baseline, 14, 30, 60, 90, and 180 days post-operation.
Time Frame
baseline, 14, 30, 60, 90, and 180 days post-operation
Title
Subjects self-evaluating Visual Analogue Scale (VAS) in satisfaction
Description
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'.
Time Frame
14, 30, 60, 90, and 180 days post-operation
Title
The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE).
Description
The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE).
Time Frame
baseline, 14, 30, 60, 90, and 180 days post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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; 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.
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Municipal Ta-Tung Hospital
City
Kaohsiung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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