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

Not Applicable

Completed

• Conditions: Flat Feet
• Interventions: Procedure: morphological and functional evaluation of adult flat foot

• Registration Number: NCT04174482
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-03
• Status Verified: 2019-11
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-22
• Primary Completion: 2020-12-03
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
flat foot patients	morphological and functional evaluation of adult flat foot	20 patients recruited consecutively and candidates for surgery to correct the adult flat foot according to the Grice technique.

Primary Outcome Measures

Name	Time	Method
Weight bearing computed tomography parameter	change from baseline at 6-months	calcaneal pitch angle (degree)
Gait Analysis parameter	change from baseline at 6-months	medial longitudinal arch

Secondary Outcome Measures

Name	Time	Method
Pain clinical examination parameter	pre-operative phase and at a 6-months follow-up from the intervention	visual analogue scale of the foot
Function clinical examination parameter	pre-operative phase and at a 6-months follow-up from the intervention	Foot function Index
Posture clinical examination parameter	pre-operative phase and at a 6-months follow-up from the intervention	Foot Posture Index

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy