Biomechanical Functional Evaluation of Plantar Pressures After Foot and Ankle Surgeries

The described surgical techniques for the treatment of foot and ankle pathologies are numerous. In order to objectively assess the outcomes of these procedures, evaluation methods are typically used, primarily considering pain symptoms, residual functionality, the correction of any deformities achieved, and radiographic parameters. Conversely, assessments of plantar pressures, as a potential indicator of functional and biomechanical recovery, are still not widely utilized. Biomechanical functional assessments examine specific variables, including gait analysis, stabilometry, kinematics and kinetics of joint movements, and the activation and strength of particular muscle groups. These assessments can be conducted by specialized personnel using dedicated equipment such as a baropodometric platform and inertial sensors.

This study aims to, for the first time in the literature, present the results related to plantar pressures from different surgical treatments of the foot and ankle

Study Overview

• Status: Recruiting
• Conditions: Plantar Pressure
• Intervention / Treatment: Other: Plantar pressure

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cesare Faldini, Prof; Phone Number: 368 0516366; Email: cesare.faldini@ior.it
• Study Contact Backup: Name: Antonio Mazzotti, PhD; Phone Number: 368 0516366; Email: antonio.mazzotti@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Cesare Faldini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who need to undergo surgical intervention
• Patients of both sexes aged between 18-75 years
• Patients who have provided their written informed consent to participate in the study
• Patients who have expressed their willingness to attend the Institute for the 6-month follow-up

Exclusion Criteria:

• Patients with severe postural instability
• Patients with cognitive deficits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Post-surgical foot and ankle patients	Other: Plantar pressure; Biomechanical functional assessments investigate specific variables: gait analysis, stabilometry, kinematics and kinetics of joint movements, activation, and strength of specific muscle groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Visual Analogue Scale (VAS) is one of the pain rating scales. It is unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).	At baseline (day 0)
Visual Analogue Scale	Visual Analogue Scale (VAS) is one of the pain rating scales. It is unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).	After 6 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• Giannini S. Kenneth A. Johnson Memorial Lecture. Operative treatment of the flatfoot: why and how. Foot Ankle Int. 1998 Jan;19(1):52-8. doi: 10.1177/107110079801900111. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2021
• Primary Completion (Actual): March 20, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: ankle; Post-operative; foot; plantar pressure
• Other Study ID Numbers: PresP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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