Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT04822558
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2021-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D Multisegment Foot Model Used for the Clinical Outcome After Ankle and Hindfoot Reconstruction
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
The Relevance of a 3D Multisegment Foot Model in Predicting and Determining the Clinical Outcome After Ankle and Hindfoot Reconstruction Procedures
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3D-MFM
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: