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 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
1 other identifier
interventional
50
1 country
1
Brief 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. With applying crosslinking hyaluronan hydrogel, the range of motion (ROM) of the ankle is expected to be better than sham group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2025
CompletedFirst Posted
Study publicly available on registry
February 14, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
CompletedFebruary 14, 2025
February 1, 2025
1.2 years
February 10, 2025
February 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Range of Motion (ROM)
Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.
day 14
Secondary Outcomes (7)
Range of Motion (ROM)
baseline, day 28, 49, 70
Anterior Talar Translation (ATT)
baseline, day 14, 28, 49, 70
Visual Analogue Scale (VAS) for pain
baseline, day 14, 28, 49, 70
Cumberland Ankle Instability Tool (CAIT) questionnaire
baseline, day 14, 28, 49, 70
American Orthopedic Foot and Ankle Society (AOFAS) questionnaire
baseline, day 14, 28, 49, 70
- +2 more secondary outcomes
Study Arms (2)
Absorbable Adhesion Barrier
EXPERIMENTALDEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe
Sham
SHAM COMPARATORconventional therapy without using any antiadhesion product
Interventions
DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Talent Cro Inc.lead
Study Sites (1)
Show Chwan Memorial Hospital
Changhua, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2025
First Posted
February 14, 2025
Study Start
March 1, 2025
Primary Completion
April 30, 2026
Study Completion
June 30, 2026
Last Updated
February 14, 2025
Record last verified: 2025-02