Ankle and Hindfoot Alterations3D-MFMNCT04822558
3D Multisegment Foot Model Used for the Clinical Outcome After Ankle and Hindfoot Reconstruction
A study testing Plantar pressure measurement, Gait analysis and Ankle and hindfoot reconstruction surgery in people with Ankle and Hindfoot Alterations, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle and Hindfoot Alterations
- What is being tested?
- Plantar pressure measurement, Gait analysis and Ankle and hindfoot reconstruction surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2013to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kevin Deschamps contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle and Hindfoot Alterations
- Being tested
- Plantar pressure measurement, Gait analysis, Ankle and hindfoot reconstruction surgery
- Keywords
- 3D multisegment foot model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantar pressure measurementOther
Biomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model
Gait analysisOther
Biomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model
Ankle and hindfoot reconstruction surgeryProcedure or surgery
Ankle and hindfoot reconstruction surgery
| Study group | Role | What they receive |
|---|---|---|
| Ankle and hindfoot reconstruction surgery | Other | Patients who underwent an ankle- or hindfoot reconstruction surgery Receives: Other: Plantar pressure measurement; Other: Gait analysis; Procedure: Ankle and hindfoot reconstruction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre-operative and at 1 year
Secondary outcomes (4)
3D motion analysis: Gaitlab parameters to determine biomechanical parameters
To determine which biomechanical parameter is the driving force for specific clinical observations using a 3D multisegment foot model
Measured: 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
Measured: 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
Measured: Pre-operative, at 6 months and at 1 year
Visual Analog Scale (VAS)
To determine the pain intensity
Measured: Pre-operative, at 6 months and at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Mar 2013
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle and Hindfoot AlterationsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Matricali, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822558
- Sponsor's protocol ID
- S55070
- Acronym
- 3D-MFM
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2021
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relevance of a 3D Multisegment Foot Model in Predicting and Determining the Clinical Outcome After Ankle and Hindfoot Reconstruction Procedures
- ClinicalTrials.gov ID
- NCT04822558
- Acronym / sponsor ID
- 3D-MFM / S55070
- Conditions
- Ankle and Hindfoot Alterations
- Keywords
- 3D multisegment foot model
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle and hindfoot reconstruction surgery | Other | Other: Plantar pressure measurement, Other: Gait analysis, Procedure: Ankle and hindfoot reconstruction surgeryPatients who underwent an ankle- or hindfoot reconstruction surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being routinely scheduled for a reconstructive surgical procedure for the following indications or involving the following type of procedure:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plantar pressure measurementBiomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model | Other | Ankle and hindfoot reconstruction surgery |
| Gait analysisBiomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model | Other | Ankle and hindfoot reconstruction surgery |
| Ankle and hindfoot reconstruction surgeryAnkle and hindfoot reconstruction surgery | Procedure or surgery | Ankle and hindfoot reconstruction surgery |
Primary outcome
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
4 secondary outcomes
3D motion analysis: Gaitlab parameters to determine biomechanical parameters
Time frame: Pre-operative and at 1 year
Foot Function Index (FFI)
Time frame: Pre-operative, at 6 months and at 1 year
Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: Pre-operative, at 6 months and at 1 year
Visual Analog Scale (VAS)
Time frame: Pre-operative, at 6 months and at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Deschamps contact
Giovanni Matricali principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plantar pressure measurement, Gait analysis and Ankle and hindfoot reconstruction surgery in people with Ankle and Hindfoot Alterations, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Matricali (+32 16 33 88 44, giovanni.matricali@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gaitlab parameters (time frame: Pre-operative and at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.