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RECRUITING
NCT06826898
NA

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

Sponsor: Talent Cro Inc.

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-03-01

Completion Date

2026-06-30

Last Updated

2025-02-14

Healthy Volunteers

No

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

Locations (1)

Show Chwan Memorial Hospital

Changhua, Taiwan