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NCT Number: NCT06826898

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Show Chwan Memorial Hospital

Changhua, Taiwan

Location status: Recruiting

Location contact

Yan-Yu Chen doctor

CONTACT

[email protected]

+88647684326

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

DEFEHERE Absorbable Adhesion Barrier

Device

DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe

Sham (No Treatment)

Device

conventional therapy without using any antiadhesion product

Primary outcomes

  1. Range of Motion (ROM)

    Time frame: day 14

    Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.

Secondary outcomes

  1. Range of Motion (ROM)

    Time frame: baseline, day 28, 49, 70

    Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.

  2. Anterior Talar Translation (ATT)

    Time frame: baseline, day 14, 28, 49, 70

    On the sagittal plane, the talus below the tibia will be pulled forward to test the integrity of the anterior talofibular ligament.

  3. Visual Analogue Scale (VAS) for pain

    Time frame: baseline, day 14, 28, 49, 70

    The VAS scale uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'

  4. Cumberland Ankle Instability Tool (CAIT) questionnaire

    Time frame: baseline, day 14, 28, 49, 70

    The Cumberland Ankle Instability Tool (CAIT) is a 9-item 30-point scale that measures the severity of functional ankle instability.

  5. American Orthopedic Foot and Ankle Society (AOFAS) questionnaire

    Time frame: baseline, day 14, 28, 49, 70

    AOFAS includes 9 items that can be divided into three subscales (pain, function and alignment).

  6. Foot and Ankle Ability Measure (FAAM) questionnaire

    Time frame: baseline, day 14, 28, 49, 70

    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.

  7. Subject self-assessment satisfaction scores

    Time frame: day 14, 28, 49, 70

    Subject self-assessment satisfaction scores

Study contacts

Contact information is provided by the study sponsor or research team.

Yan-Yu Chen Doctor

CONTACT

[email protected]

+88647684326

Sponsors and collaborators

Lead sponsor

Talent Cro Inc.

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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