Trigger FingerNCT05082480
Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery
A study testing Hyaluronic acid (HA) and Saline in people with Trigger Finger and Hyaluronic Acid, run by SciVision Biotech Inc. at 2 sites in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Trigger Finger, Hyaluronic Acid
- What is being tested?
- Hyaluronic acid (HA) and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 2 sitesTaiwan
- Study dates
- 5 May 2022to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Kaohsiung Municipal Ta-Tung Hospital
Kaohsiung City
About this study
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
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
Read the 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.
- Conditions
- Trigger Finger, Hyaluronic Acid
- Being tested
- Hyaluronic acid (HA), Saline
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid (HA)Device
Hyaluronic acid (HA)
SalineDevice
Saline
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid (HA) | Experimental | Hyaluronic acid (HA) Receives: Device: Hyaluronic acid (HA) |
| Saline | Placebo comparator | Saline Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post-operation
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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'
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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).
Measured: baseline, 14, 30, 60, 90, and 180 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start5 May 2022
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciVision Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082480
- Sponsor's protocol ID
- RDCT-TWDH
- Status last verified
- May 2022
- First submitted
- 5 Oct 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05082480
- Acronym / sponsor ID
- RDCT-TWDH
- Conditions
- Trigger Finger, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- SciVision Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 5 May 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid (HA) | Experimental | Device: Hyaluronic acid (HA)Hyaluronic acid (HA) |
| Saline | Placebo comparator | Device: SalineSaline |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid (HA)Hyaluronic acid (HA) | Device | Hyaluronic acid (HA) |
| SalineSaline | Device | Saline |
Primary outcome
The percentage of Total Active Motion (TAM) score for target finger.
Time frame: 30 days post-operation
The percentage of Total Active Motion (TAM) score for target finger at 30 days post-operation.
8 secondary outcomes
The percentage of TAM score of target finger.
Time frame: baseline, 14, 60, 90, and 180 days post-operation
TAM score of target finger.
Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation
The grade of TAM score of target finger and contralateral finger.
Time frame: 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.
Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation
Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash).
Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation
The evaluation of tendon by sonography.
Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation
Subjects self-evaluating Visual Analogue Scale (VAS) in satisfaction
Time frame: 14, 30, 60, 90, and 180 days post-operation
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
Results and safety
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid (HA) and Saline in people with Trigger Finger and Hyaluronic Acid, run by SciVision Biotech Inc. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of Total Active Motion (TAM) score for target finger. (time frame: 30 days post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.