Using a 3D foot model to assess outcomes after ankle and hindfoot surgery
The Relevance of a 3D Multisegment Foot Model in Predicting and Determining the Clinical Outcome After Ankle and Hindfoot Reconstruction Procedures
This study is testing a new 3D foot model to see how well ankle and hindfoot surgeries work by looking at how people walk and how pressure is distributed on their feet after the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT04822558 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical outcomes of ankle and hindfoot reconstruction surgeries by utilizing a validated 3D multisegment foot model. The approach integrates gait analysis and plantar pressure measurements to provide a comprehensive understanding of biomechanical alterations in the foot and ankle region. By linking these two modalities, the study aims to improve the assessment of surgical interventions and their impact on biomechanical parameters. The research is conducted at UZ Leuven, where the advanced gait lab facilities are available for detailed analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals scheduled for reconstructive surgery for conditions such as Pes Planus, Pes Plano-valgus, or Posterior Tibial Tendon Dysfunction.
Not a fit: Patients who are under 18 years old or have significant mobility limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and rehabilitation strategies for patients undergoing ankle and hindfoot reconstruction.
How similar studies have performed: While the integration of gait analysis and plantar pressure measurements is a novel approach, similar studies have shown promise in improving surgical outcomes through biomechanical assessments.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Giovanni Matricali — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Giovanni Matricali
- Email: giovanni.matricali@uzleuven.be
- Phone: +32 16 33 88 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.