Verification of thickness change rate and shear modulus of ankle soft tissue

UMIN ID: UMIN000051851

Registered date:01/09/2023

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Open Reduction and Internal Fixation of Ankle Fractures
• Date of first enrollment: 2022/05/27
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The evaluation periods were 3 months and 6 months after surgery. The measurement positions were 10degree ankle plantar flexion and 0degree plantar dorsiflexion in the resting standing position. The tibialis anterior tendon, extensor hallucis longus tendon, and extensor hallucis longus tendon were visualized on long-axis images of the talar pulley and tibia using an ultrasound machine. Anterior soft tissue thickness was measured as the shortest distance from the convexity of the talar pulley to the tendon directly above it. The rate of change in anterior ankle soft tissue thickness was determined by dividing the value at 0degree ankle plantar dorsiflexion by the value at 10degree plantar flexion. The average shear modulus (kPa) was calculated using shear-wave elastography.

Key inclusion & exclusion criteria

• Age minimum: 12years-old
• Age maximum: 81years-old
• Gender: Male and Female
• Exclude criteria: Dorsiflexion range of motion less than 0degree, history of neurological lesion, Chronic Ankle Instability, painful big toe under load, and FPI6 score of 6 or more for the medial foot and 0 or less for the external foot.

Related Information

• Primary Sponsor: Keiyu Orthopaedic Hospital
• Source(s) of Monetary Support: None