NCT06090357

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jul 2021May 2026

Study Start

First participant enrolled

July 10, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

October 13, 2023

Last Update Submit

July 17, 2025

Conditions

Plantar Pressure

Keywords

footanklePost-operativeplantar pressure

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Post-surgical foot and ankle patients

EXPERIMENTAL
Other: Plantar pressure

Interventions

Plantar pressureOTHER

Biomechanical functional assessments investigate specific variables: gait analysis, stabilometry, kinematics and kinetics of joint movements, activation, and strength of specific muscle groups.

Post-surgical foot and ankle patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with severe postural instability
  • Patients with cognitive deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 9462915RESULT

Central Study Contacts

Cesare Faldini, Prof

CONTACT

0516366cesare.faldini@ior.it

Antonio Mazzotti, PhD

CONTACT

0516366antonio.mazzotti@ior.it

Study Design

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

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

July 10, 2021

Primary Completion

March 20, 2024

Study Completion (Estimated)

May 31, 2026

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)