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

Pilot Study of Morphological and Functional Evaluation of Adult Flat Foot by Weight Bearing CT and Gait Analysis 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.

Study Overview

• Status: Unknown
• Conditions: Flat Feet
• Intervention / Treatment: Procedure: morphological and functional evaluation of adult flat foot

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Berti, MD; Phone Number: 529 051.63.66; Email: lisa.berti@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Lisa Berti, MD; Phone Number: 529 051.63.66; Email: lisa.berti@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: flat foot patients; 20 patients recruited consecutively and candidates for surgery to correct the adult flat foot according to the Grice technique.	Procedure: morphological and functional evaluation of adult flat foot; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• Burssens A, Peeters J, Buedts K, Victor J, Vandeputte G. Measuring hindfoot alignment in weight bearing CT: A novel clinical relevant measurement method. Foot Ankle Surg. 2016 Dec;22(4):233-238. doi: 10.1016/j.fas.2015.10.002. Epub 2015 Oct 30.
• Buldt AK, Levinger P, Murley GS, Menz HB, Nester CJ, Landorf KB. Foot posture is associated with kinematics of the foot during gait: A comparison of normal, planus and cavus feet. Gait Posture. 2015 Jun;42(1):42-8. doi: 10.1016/j.gaitpost.2015.03.004. Epub 2015 Mar 12.
• Leardini A, Benedetti MG, Berti L, Bettinelli D, Nativo R, Giannini S. Rear-foot, mid-foot and fore-foot motion during the stance phase of gait. Gait Posture. 2007 Mar;25(3):453-62. doi: 10.1016/j.gaitpost.2006.05.017. Epub 2006 Sep 11.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Anticipated): December 3, 2020
• Study Completion (Anticipated): December 3, 2020

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: CBCT-PIEDE PIATTO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No