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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Talent Cro Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	DEFEHERE Absorbable Adhesion Barrier	DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe
DEVICE	Sham (No Treatment)	conventional therapy without using any antiadhesion product

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2025-02-14
• Last updated: 2025-02-14

Locations

1 site across 1 country: Taiwan