The Relevance of a 3D Multisegment Foot Model in Predicting and Determining the Clinical Outcome After Ankle and Hindfoot Reconstruction Procedures

Most symptomatic pathologies of the ankle and hindfoot are determined by biomechanical alterations of this anatomical region. Surgical treatment of these pathologies is therefore aimed at improving the inferior biomechanical condition, and it can be expected that an improvement of the biomechanical parameters grossly parallels the targeted clinical improvement.

3D Multisegment Foot Models have been developed and validated to determine the clinical outcome. Such a validated 3D Multisegment Foot Model is now standard available in the gaitlab of UZ Leuven making it possible to study a huge amount of biomechanical parameters within the foot & ankle region itself.

Study Overview

• Status: Recruiting
• Conditions: Ankle and Hindfoot Alterations
• Intervention / Treatment: Other: Plantar pressure measurement; Other: Gait analysis; Procedure: Ankle and hindfoot reconstruction surgery

Detailed Description

Most symptomatic pathologies of the ankle and hindfoot are determined by biomechanical alterations of this anatomical region. Surgical treatment of these pathologies is therefore aimed at improving the inferior biomechanical condition, and it can be expected that an improvement of the biomechanical parameters grossly parallels the targeted clinical improvement.

Unfortunately, in the past, biomechanical examination of the lower limb and foot consisted of two distinct study protocols: gaitlab and plantar pressure measurements.

First, these two study protocols were acquired completely independently. Therefore, it proved to be very hard to compare the results and get insight in the way altered biomechanics caused or continued to cause abnormal plantar pressure distributions. However, recently it was possible to integrate these two modalities, especially concerning the timing of the events, what makes it possible to reliably link the observed findings.

Second, virtually all gaitlab models considered the foot & ankle region as one single segment, making it impossible to evaluate any biomechanical parameter within the targeted region. 3D Multisegment Foot Models have been developed and validated since the beginning of this century. Such a validated 3D Multisegment Foot Model is now standard available in the gaitlab of UZ Leuven making it possible to study a huge amount of biomechanical parameters within the foot & ankle region itself.

Furthermore, only a paucity of information is available if the observed clinical changes are indeed paralleled by an equally directed biomechanical change.

Historically, all patients at the Foot & Ankle unit of UZ Leuven performed a pre- and 1 year post-operative plantar pressure measurement to get better insight in their clinical condition. As stated before, the usefulness of this single testing method was limited. Recently the Advanced Clinical Examination Platform that integrates both plantar pressure measurement and full 3D MFM-gaitlab has been implemented in the Movement Analysis Laboratory of our institution. Currently a transition to routinely perform such an examination is finished. Therefore a completely new era of research concerning the biomechanical evaluation itself and clinical results of the reconstructive procedures of ankle and hindfoot has started.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giovanni Matricali; Phone Number: +32 16 33 88 44; Email: giovanni.matricali@uzleuven.be
• Study Contact Backup: Name: Kevin Deschamps; Email: kevin.deschamps@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being routinely scheduled for a reconstructive surgical procedure for the following indications or involving the following type of procedure:

  1. Any reconstructive procedure for Pes Planus, Pes Plano-valgus, or Posterior Tibial Tendon Dysfunction
  2. Tibio-talar arthrodesis or prosthesis
  3. Sub-talar -and/or (partial) Chopart - and/or Triple arthrodesis

  4. Pantalar arthrodesis with or without inclusion of the Chopart joint

     Exclusion Criteria:

• Age under 18
• Need of tools (eg walker or crutches) to walk less than 100m
• Inability to walk less than 100 m anyway
• Differences in leg length exceeding 3 cm (measured clinically)
• Extreme in-or outtoeing
• Subjects with BMI > 27.5 require very careful further consideration whether or not the obesity prevents the accurate palpation of anatomical landmarks necessary prior to marker placement. This will be judged on an individual basis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Ankle and hindfoot reconstruction surgery; Patients who underwent an ankle- or hindfoot reconstruction surgery

Other: Plantar pressure measurement; Biomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model; Other: Gait analysis; Biomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model; Procedure: Ankle and hindfoot reconstruction surgery; Ankle and hindfoot reconstruction surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gaitlab parameters	To determine the correlation between the observed changes in gaitlab parameters and the observed changes at plantar pressure measurement and to determine if a clear correlation can be determined, comparing the pre- and post-operative results 3D multisegment foot model testing and clinical outcome	Pre-operative and at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gaitlab parameters	To determine which biomechanical parameter is the driving force for specific clinical observations using a 3D multisegment foot model	Pre-operative and at 1 year
Foot Function Index (FFI)	To measure the impact of foot pathology on function in terms of pain, disability and activity restriction	Pre-operative, at 6 months and at 1 year
Short Form 36 Health Survey Questionnaire (SF-36)	To indicate the health status and pain scales	Pre-operative, at 6 months and at 1 year
Visual Analog Scale (VAS)	To determine the pain intensity	Pre-operative, at 6 months and at 1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (ACTUAL): March 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: 3D multisegment foot model
• Other Study ID Numbers: S55070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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