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A Prospective, Single-center, Randomized, Double-blinded Clinical Study to Evaluate the Effectiveness of a Novel Crosslinking Hyaluronan Hydrogel for Preventing Adhesions After Anterior Talofibular Ligament Repair Surgery
Led by Talent Cro Inc. · Updated on 2025-02-14
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a new crosslinking hyaluronan hydrogel in preventing adhesions after anterior talofibular ligament (ATFL) repair surgery. The study focuses on patients with ATFL injury who experience lateral ankle pain and have a history of recurrent ankle sprains. The goal is to see if applying this hydrogel improves ankle range of motion compared to conventional therapy without antiadhesion products. Participants are randomly assigned to receive either the DEFEHERE Absorbable Adhesion Barrier hydrogel or conventional therapy without any antiadhesion product. The hydrogel is delivered as a 1.0 mL syringe during surgery. The study is conducted as a prospective, single-center, randomized, double-blinded clinical trial. The main treatment phase includes monitoring over a period up to 70 days after surgery. During the study, participants will undergo various assessments including range of motion measurements, anterior talar translation tests, pain scales, and questionnaires assessing ankle instability and function. These evaluations occur at baseline and multiple points up to day 70 after surgery. Researchers will also collect patient satisfaction scores and monitor for any adverse effects. The total participation period includes follow-up visits over approximately 10 weeks.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign an informed consent form
- Age 18 to 60 years, male or female
- Lateral ankle pain confirmed by MRI to have anterior talofibular ligament injury
- History of three or more recurrent ankle inversion sprains with no improvement after six months of conservative treatment
- Scheduled for anterior talofibular ligament repair surgery
- Willing to comply with all follow-up requirements of the trial protocol
You will not qualify if you...
- Severe ankle osteoarthritis
- History of ankle fracture or previous ankle surgery
- Undergoing foot- or ankle-related treatments that may affect trial results
- Skin infection, skin defects, or need for skin grafting at the surgical site
- Uncontrolled chronic diseases such as diabetes mellitus
- Autoimmune diseases, malignancies, coagulation disorders, heart diseases, psychiatric illnesses, or other high-risk conditions
- Use of corticosteroids within past 6 months or systemic corticosteroids within past month, immunosuppressive drugs within past 3 months, or daily use of NSAIDs within past week
- Clinically significant coagulation abnormalities or use of anticoagulants near time of surgery
- Known allergy to sodium hyaluronate, medical device components, or severe allergic history
- Pregnant, lactating, or planning pregnancy during trial
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo anterior talofibular ligament repair surgery during which they receive either the DEFEHERE Absorbable Adhesion Barrier device or no antiadhesion treatment.
1 visit (in-person)
Duration - Up to 10 weeks after surgery
Participants are monitored after surgery to evaluate recovery, range of motion, pain levels, ankle stability, and satisfaction.
Visits on days 14, 28, 49, and 70 (in-person)
Trial Site Locations
Total: 1 location
1
Show Chwan Memorial Hospital
Changhua, Taiwan
Actively Recruiting
Research Team
Y
Yan-Yu Chen Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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