Biomechanical and Morphological Characterization of PTTD
PTTD
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
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 Start
First participant enrolled
August 22, 2022
CompletedFirst Submitted
Initial submission to the registry
December 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
April 15, 2025
April 1, 2025
5.9 years
December 8, 2023
April 10, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
Kinematic characteristics during Gait analysis
Range of Motion (ROM) of PTTD patient of each stage will be obtained and compared between the patient groups (PTTD 1-2-3) and a control group.
1 year
Center of pressure during Gait analysis
The center of pressure (kinetic characteristic) of PTTD patients of each stage will be obtained and compared between the patient groups (PTTD 1-2-3) and a control group. This information can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform.
1 year
Angular velocity during Gait analysis
The angular velocity (kinetic characteristic) of PTTD patients of each stage will be obtained and compared between the patient groups (PTTD 1-2-3) and a control group. This information can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform.
1 year
Moment during Gait analysis
The moment (kinetic characteristic) of PTTD patients of each stage will be obtained and compared between the patient groups (PTTD 1-2-3) and a control group. This information can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform.
1 year
Power absorption during Gait analysis
The power absorption (kinetic characteristic) of PTTD patients of each stage will be obtained and compared between the patient groups (PTTD 1-2-3) and a control group. This information can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform.
1 year
Power generation during Gait analysis
The power generation (kinetic characteristic) of PTTD patients of each stage will be obtained and compared between the patient groups (PTTD 1-2-3) and a control group. This information can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform.
1 year
Bone morphology
Morphological characteristics of PTTD patients of each stage will be obtained by CT-scan and statistical shape modeling and compared between the study groups and a control group.
1 year
Secondary Outcomes (5)
American Orthopaedic Foot & Ankle Society (AOFAS) score
1 year
European Foot and Ankle Society (EFAS) score
1 year
36-item Short Form Health Survey (SF36)
1 year
Visual Analogue Scale (VAS) pain
1 year
Visual Analogue Scale (VAS) satisfaction
1 year
Study Arms (2)
PTTD patients (PTTD I, II and III)
EXPERIMENTAL75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III)
Healthy control group
EXPERIMENTAL25 healthy volunteers
Interventions
X-rays of the ankle; anterior-posterior, lateral, Mortise view and hindfoot alignment view. Standard weight bearing x-rays of the foot; anterior-posterior, lateral and oblique view.
Ultrasound of the posterior tibial tendon to see if there is an irritation, elongation or rupture.
MRI when ultrasound is not conclusive to identify an irritation, elongation or rupture of the posterior tibial tendon.
CT-scan to identify arthritis of the tibial-talar, subtalar and/or Chopart joints.
This lab is equipped with a 10-meter walkway surrounded by a passive optoelectronic motion analysis system consisting of 10 cameras to track the motion of markers. In the middle of the walkway, a force plate is integrated, with a pressure plate placed on top.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sander Wuite
Universitaire Ziekenhuizen KU Leuven
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- PTTD patients (PTTD I, II and III) and a healthy control group.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2023
First Posted
February 15, 2024
Study Start
August 22, 2022
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
April 15, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share