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
NCT06826898 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-02-14
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.
Conditions
- Anterior Talofibular Ligament Injury
Interventions
- DEVICE
-
DEFEHERE Absorbable Adhesion Barrier
DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe
- DEVICE
-
Sham (No Treatment)
conventional therapy without using any antiadhesion product
Sponsors & Collaborators
-
Talent Cro Inc.
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2026-04-30
- Completion
- 2026-06-30
Countries
- Taiwan
Study Locations
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