Anterior Talofibular Ligament InjuryNCT06826898
To Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery
A study testing DEFEHERE Absorbable Adhesion Barrier in people with Anterior Talofibular Ligament Injury, run by Talent Cro Inc. at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after anterior talofibular ligament repair surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Talofibular Ligament Injury
- What is being tested?
- DEFEHERE Absorbable Adhesion Barrier
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2025to 30 Jun 2026
- Phase
- Interventional
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1.1 Voluntarily participate and sign an informed consent form; 1.2 Age 18 to 60 years of male or female; 1.3 Patients experiencing lateral ankle pain discomfort, confirmed by MRI to have anterior talofibular ligament (ATFL) injury; 1.4 History of recurrent ankle inversion sprains three times or more, with no improvement after six months of conservative treatment, and scheduled for ATFL repair surgery; 1.5 Willing to comply with all follow-up requirements of the trial protocol.
Who cannot join
- 2.1 Severe ankle osteoarthritis; 2.2 Patients with a history of ankle fracture or surgery; 2.3 Undergoing foot- or ankle-related treatments that may affect the trial results; 2.4 Presence of skin infection, skin defects, or need for skin grafting at the surgical site; 2.5 Uncontrolled chronic diseases, such as diabetes mellitus; 2.6 Presence of autoimmune diseases (such as Autoimmune Collagenopathy, rheumatoid arthritis), malignancies, coagulation disorders, heart diseases, psychiatric illnesses, or other conditions that may pose higher risks to patients in the trial; 2.7 Use of corticosteroids within the past 6 months, systemic corticosteroids within the past month, immunosuppressive drugs within the past 3 months, or daily use of non-steroidal anti-inflammatory drugs (NSAIDs) within the past week, or occasional use within 8 hours (patients using nasal/inhaled corticosteroids may be considered for inclusion) ; 2.8 Clinically significant coagulation abnormalities or undergoing anticoagulant therapy within 10 days before surgery or currently taking anticoagulant drugs; 2.9 Known allergy to sodium hyaluronate or any components of medical devices;allergy to Gram-positive bacterial protein or streptococcal protein；or other severe allergic history deemed unsuitable for participation by the investigators; 2.10 Pregnant, lactating women, or women planning to become pregnant during the trial period; 2.11 Other conditions deemed unsuitable for participation by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Show Chwan Memorial Hospital
Changhua
Yan-Yu Chen doctor, +88647684326, swallowfish@gmail.com
About this study
Official title: A Prospective, Single-center, Randomized, Evaluator/subject-blinded, Controlled Clinical Study: to Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery
The goal of this clinical trial is to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after anterior talofibular ligament repair surgery. With applying crosslinking hyaluronan hydrogel, the range of motion (ROM) of the ankle is expected to be better than sham group.
- Conditions
- Anterior Talofibular Ligament Injury
- Being tested
- DEFEHERE Absorbable Adhesion Barrier, Sham (No Treatment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEFEHERE Absorbable Adhesion BarrierDevice
DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe
Sham (No Treatment)Device
conventional therapy without using any antiadhesion product
| Study group | Role | What they receive |
|---|---|---|
| Absorbable Adhesion Barrier | Experimental | DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe Receives: Device: DEFEHERE Absorbable Adhesion Barrier |
| Sham | Sham comparator | conventional therapy without using any antiadhesion product Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion (ROM)
Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.
Measured: day 14
Secondary outcomes (7)
Range of Motion (ROM)
Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.
Measured: baseline, day 28, 49, 70
Anterior Talar Translation (ATT)
On the sagittal plane, the talus below the tibia will be pulled forward to test the integrity of the anterior talofibular ligament.
Measured: baseline, day 14, 28, 49, 70
Visual Analogue Scale (VAS) for pain
The VAS scale uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'
Measured: baseline, day 14, 28, 49, 70
Cumberland Ankle Instability Tool (CAIT) questionnaire
The Cumberland Ankle Instability Tool (CAIT) is a 9-item 30-point scale that measures the severity of functional ankle instability.
Measured: baseline, day 14, 28, 49, 70
American Orthopedic Foot and Ankle Society (AOFAS) questionnaire
AOFAS includes 9 items that can be divided into three subscales (pain, function and alignment).
Measured: baseline, day 14, 28, 49, 70
Foot and Ankle Ability Measure (FAAM) questionnaire
A self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The FAAM is a 31-item questionnaire divided into two subscales: Activities of Daily Living Subscale and Sports Subscale.
Measured: baseline, day 14, 28, 49, 70
Subject self-assessment satisfaction scores
Subject self-assessment satisfaction scores
Measured: day 14, 28, 49, 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Talofibular Ligament InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Talent Cro Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826898
- Sponsor's protocol ID
- RDCT-SCDH
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided