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

NCT04174482 | Completed

• 1 other identifier: CBCT-PIEDE PIATTO
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Flat Feet

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pain clinical examination parameter

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

• Posture clinical examination parameter

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

• Function clinical examination parameter

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

Study Arms (1)

flat foot patients

EXPERIMENTAL

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

Interventions

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

flat foot patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (3)

• 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.

  PMID: 27810020 RESULT

• 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.

  PMID: 25819716 RESULT

• 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.

  PMID: 16965916 RESULT

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 22, 2019
• Study Start: December 3, 2018
• Primary Completion: December 3, 2020
• Study Completion: December 31, 2022
• Last Updated: February 2, 2023

Record last verified: 2019-11

Locations

IT (1)