NCT04822558

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Mar 2013Dec 2026

Study Start

First participant enrolled

March 1, 2013

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

13.8 years

First QC Date

March 17, 2021

Last Update Submit

March 12, 2026

Conditions

Ankle and Hindfoot Alterations

Keywords

3D multisegment foot model

Outcome Measures

Primary Outcomes (1)

  • 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

    Pre-operative and at 1 year

Secondary Outcomes (4)

  • 3D motion analysis: Gaitlab parameters to determine biomechanical parameters

    Pre-operative and at 1 year

  • Foot Function Index (FFI)

    Pre-operative, at 6 months and at 1 year

  • Short Form 36 Health Survey Questionnaire (SF-36)

    Pre-operative, at 6 months and at 1 year

  • Visual Analog Scale (VAS)

    Pre-operative, at 6 months and at 1 year

Study Arms (1)

Ankle and hindfoot reconstruction surgery

OTHER

Patients who underwent an ankle- or hindfoot reconstruction surgery

Other: Plantar pressure measurementOther: Gait analysisProcedure: Ankle and hindfoot reconstruction surgery

Interventions

Plantar pressure measurementOTHER

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

Ankle and hindfoot reconstruction surgery
Gait analysisOTHER

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

Ankle and hindfoot reconstruction surgery
Ankle and hindfoot reconstruction surgeryPROCEDURE

Ankle and hindfoot reconstruction surgery

Ankle and hindfoot reconstruction surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Giovanni Matricali

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Matricali

CONTACT

+32 16 33 88 44giovanni.matricali@uzleuven.be

Kevin Deschamps

CONTACT

kevin.deschamps@uzleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 30, 2021

Study Start

March 1, 2013

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)