UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
NCT Number: NCT04822558
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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All sexes
Interventional
Not applicable
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Biomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model
Biomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model
Ankle and hindfoot reconstruction surgery
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
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
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
Time frame: Pre-operative, at 6 months and at 1 year
To indicate the health status and pain scales
Time frame: Pre-operative, at 6 months and at 1 year
To determine the pain intensity
Contact information is provided by the study sponsor or research team.
Giovanni Matricali
CONTACT
Kevin Deschamps
CONTACT
Universitaire Ziekenhuizen KU Leuven
Other
The Relevance of a 3D Multisegment Foot Model in Predicting and Determining the Clinical Outcome After Ankle and Hindfoot Reconstruction Procedures
Acronym: 3D-MFM
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