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

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ClinicalTrials.gov Identifier: NCT04822558
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ankle and Hindfoot Alterations Other: Plantar pressure measurement Other: Gait analysis Procedure: Ankle and hindfoot reconstruction surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Relevance of a 3D Multisegment Foot Model in Predicting and Determining the Clinical Outcome After Ankle and Hindfoot Reconstruction Procedures
Actual Study Start Date : March 1, 2013
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Gaitlab 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04822558


Contacts
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Contact: Giovanni Matricali +32 16 33 88 44 giovanni.matricali@uzleuven.be
Contact: Kevin Deschamps kevin.deschamps@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04822558    
Other Study ID Numbers: S55070
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
3D multisegment foot model