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NCT Number: NCT04822558

3D Multisegment Foot Model Used for the Clinical Outcome After Ankle and Hindfoot Reconstruction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being routinely scheduled for a reconstructive surgical procedure for the following indications or involving the following type of procedure:
  • Any reconstructive procedure for Pes Planus, Pes Plano-valgus, or Posterior Tibial Tendon Dysfunction
  • Tibio-talar arthrodesis or prosthesis
  • Sub-talar -and/or (partial) Chopart - and/or Triple arthrodesis
  • 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.

Treatment and study plan

Plantar Pressure Measurement

Other

Biomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model

Gait Analysis

Other

Biomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model

Ankle and hindfoot reconstruction surgery

Procedure

Ankle and hindfoot reconstruction surgery

Primary outcomes

  1. Gaitlab parameters

    Time frame: Pre-operative and at 1 year

    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

Secondary outcomes

  1. 3D motion analysis: Gaitlab parameters to determine biomechanical parameters

    Time frame: Pre-operative and at 1 year

    To determine which biomechanical parameter is the driving force for specific clinical observations using a 3D multisegment foot model

  2. Foot Function Index (FFI)

    Time frame: Pre-operative, at 6 months and at 1 year

    To measure the impact of foot pathology on function in terms of pain, disability and activity restriction

  3. Short Form 36 Health Survey Questionnaire (SF-36)

    Time frame: Pre-operative, at 6 months and at 1 year

    To indicate the health status and pain scales

  4. Visual Analog Scale (VAS)

    Time frame: Pre-operative, at 6 months and at 1 year

    To determine the pain intensity

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Matricali

CONTACT

[email protected]

+32 16 33 88 44

Kevin Deschamps

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: 3D-MFM

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2021
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.