NCT04822558 3D Multisegment Foot Model Used for the Clinical Outcome After Ankle and Hindfoot Reconstruction
| NCT ID | NCT04822558 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Ankle and Hindfoot Alterations |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2013-03-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2013-03-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Giovanni Matricali
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT04822558 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ankle and Hindfoot Alterations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04822558 currently recruiting?
Yes, NCT04822558 is actively recruiting participants. Contact the research team at giovanni.matricali@uzleuven.be for enrollment information.
Where is the NCT04822558 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT04822558 clinical trial?
NCT04822558 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Giovanni Matricali at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 300 participants.