Skip to main content
OpenTrials
Completed

NCT Number: NCT04174482

Morphological and Functional Evaluation of Adult Flat Foot Before and After Corrective Surgery

Morphological weight bearing computed tomography parameters and gait analysis can implement the evaluation of the flat foot. Weight bearing CT is useful to verify the severity of the 3D deformities typical of flat foot, while kinematic and kinetic variables of gait is able to quantify the functional improvements of the foot after surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Flat Feet Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with idiopathic flat foot with indication for corrective surgical treatment according to Grice (arthrodesis of the subtalar joint)
  • age between 18 and 65 years
  • BMI less than 40
  • signature of informed consent.

Exclusion criteria

  • patients with severe alterations or other pathologies affecting the foot and lower limb
  • severe vascular and neurological systemic diseases
  • systemic diseases that can compromise bone consolidation

Treatment and study plan

morphological and functional evaluation of adult flat foot

Procedure

Evaluations are realized by weight bearing computed tomography and by Gait analysis in the pre-operative phase and at a 6-months follow-up from the surgery with Grice technique

Primary outcomes

  1. Weight bearing computed tomography parameter

    Time frame: change from baseline at 6-months

    calcaneal pitch angle (degree)

  2. Gait Analysis parameter

    Time frame: change from baseline at 6-months

    medial longitudinal arch

Secondary outcomes

  1. Pain clinical examination parameter

    Time frame: pre-operative phase and at a 6-months follow-up from the intervention

    visual analogue scale of the foot

  2. Posture clinical examination parameter

    Time frame: pre-operative phase and at a 6-months follow-up from the intervention

    Foot Posture Index

  3. Function clinical examination parameter

    Time frame: pre-operative phase and at a 6-months follow-up from the intervention

    Foot function Index

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Pilot Study of Morphological and Functional Evaluation of Adult Flat Foot by Weight Bearing CT and Gait Analysis Before and After Corrective Surgery

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Nov 22, 2019
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.