NCT06260813 Biomechanical and Morphological Characterization of PTTD
| NCT ID | NCT06260813 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Posterior Tibial Tendon Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-08-22 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 100 participants in total. It began in 2022-08-22 with a primary completion date of 2028-08-01.
⚠ 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
Posterior tibial tendon dysfunction (PTTD) is a progressive condition of the tendon of the tibialis posterior muscle with symptoms of tendinopathy or even rupture. Functionally, it is associated with the inability to lock the mid foot and thus manifests itself as a main contributor to adult acquired flatfoot deformity. Concerning treatment, clinical decision making is currently based on a classification integrating various parameters as pain, flexibility of the foot joints, the condition of the posterior tibial tendon assessed through ultrasound imaging and radiographic assessment of arthritic changes. Surprisingly, this classification does not consider any morphologic characteristics (the shape of a bone or joint) or functional, biomechanical characteristics of the foot and ankle, i.e. based on kinematics (e.g. range of motion) and/or kinetics (center of pressure, angular velocity, moment, power absorption and power generation of a joint). Detailed biomechanical characteristics of the foot and ankle can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform. Kinematic studies in the field of PTTD typically considered the foot as a structure consisting of three segments: hind foot, forefoot and hallux. Consequently, the mid foot segment (the Chopart and Lisfranc joints) has been neglected, although it is this segment that is particularly affected in PTTD patients. The aim of this research is to overcome the limitations of the current classification system and treatment of PTTD patients, by complementing the current standard-of-care clinical assessment with better insight in the pathologic changes that occur in PTTD patients.
Eligibility Criteria
Inclusion criteria: * Patient groups: * Posterior tibial tendon dysfunction (all clinical stages) * Age 18-675 year * ICF obtained * Control group: * No pain complaints * No pes plano valgus, PTTD or pes cavo varus or other foot and ankle pathology * Age 18-75 year * ICF obtained Exclusion criteria patient and control groups: * Being younger than 18 years * Inability to walk without mobility aids * Inability to walk \< 100 meter * Difference in leg length \> 3cm * Subjects with BMI\>30 kg/m², due to less accurate gait analysis by absence of anatomical landmarks * Subjects unable to perform a gait analysis * Any medical condition possibly affecting normal gait. * Pregnancy: at the start or during the study
Contact & Investigator
Sander Wuite
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT06260813 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Posterior Tibial Tendon Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06260813 currently recruiting?
Yes, NCT06260813 is actively recruiting participants. Contact the research team at sander.wuite@uzleuven.be for enrollment information.
Where is the NCT06260813 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06260813 clinical trial?
NCT06260813 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Sander Wuite at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 100 participants.