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

Flat Feet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174482
• Other study ID #: CBCT-PIEDE PIATTO
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2019
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 31, 2022
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Flat Feet
• Flatfoot

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Epu — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight bearing computed tomography parameter	calcaneal pitch angle (degree)	change from baseline at 6-months
Primary	Gait Analysis parameter	medial longitudinal arch	change from baseline at 6-months
Secondary	Pain clinical examination parameter	visual analogue scale of the foot	pre-operative phase and at a 6-months follow-up from the intervention
Secondary	Posture clinical examination parameter	Foot Posture Index	pre-operative phase and at a 6-months follow-up from the intervention
Secondary	Function clinical examination parameter	Foot function Index	pre-operative phase and at a 6-months follow-up from the intervention