Health TrialsbyHealthPanel

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

ConditionAnterior Talofibular Ligament Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTalent Cro Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • DEFEHERE Absorbable Adhesion Barrier

    Device

    DEFEHERE Absorbable Adhesion Barrier, 1.0 mL/syringe

  • Sham (No Treatment)

    Device

    conventional therapy without using any antiadhesion product

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Absorbable Adhesion BarrierExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Range of Motion (ROM)

Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.

Time frame
day 14

Secondary outcomes

1

Range of Motion (ROM)

Measure the range of plantar flexion, dorsiflexion, inversion, and eversion of the ankle.

Time frame
baseline, day 28, 49, 70
2

Anterior Talar Translation (ATT)

On the sagittal plane, the talus below the tibia will be pulled forward to test the integrity of the anterior talofibular ligament.

Time frame
baseline, day 14, 28, 49, 70
3

Visual Analogue Scale (VAS) for pain

The VAS scale uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'

Time frame
baseline, day 14, 28, 49, 70
4

Cumberland Ankle Instability Tool (CAIT) questionnaire

The Cumberland Ankle Instability Tool (CAIT) is a 9-item 30-point scale that measures the severity of functional ankle instability.

Time frame
baseline, day 14, 28, 49, 70

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Talent Cro Inc.

Lead sponsor

Source ClinicalTrials.gov
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