Posterior Tibial Tendon DysfunctionPTTDNCT06260813
Biomechanical and Morphological Characterization of PTTD
A study testing Radiography, Ultrasound and MRI in people with Posterior Tibial Tendon Dysfunction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Tibial Tendon Dysfunction
- What is being tested?
- Radiography, Ultrasound and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Aug 2022to 1 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient groups:
- Posterior tibial tendon dysfunction (all clinical stages)
- Age 18-675 year
- ICF obtained
- Control group:
- No pain complaints
Show all 9Show fewer
- No pes plano valgus, PTTD or pes cavo varus or other foot and ankle pathology
- Age 18-75 year
- ICF obtained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Sander Wuite, +32 16 33 83 29, sander.wuite@uzleuven.be
Kevin Deschamps, +32 16 33 88 27, kevin.deschamps@uzleuven.be
About this study
Official title: Biomechanical and Morphological Characterization of the Foot in Patients With Posterior Tibial Tendon Dysfunction.
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).
Read more
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.
Read the detailed description
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. Importantly, this condition is associated with severe pain, inability to walk, collapse of the foot arch and dislocation and destruction of foot joints, causing serious disability with respect to activities of daily living and professional activities.
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. PTTD stage 1 is characterized by tendinopathy and is suggested to be mainly treated conservatively. Stage 2 is characterized by a flexible flat foot deformation, mostly combined with a tear of the posterior tibial tendon. Here, treatment is suggested through osteotomies and soft tissue surgery. Stage 3 encompasses a rigid flat foot deformity associated with a fully dysfunctional posterior tibial tendon and degenerative changes of the hind foot joints. At this stage fusion of the affected joints should be considered. During recent decades, this classification has been extended with additional subgroups as well as a stage 4 which adds onto stage 3 with excessive tibio-talar valgus and is mainly treated by a complementary fusion of the ankle joint.
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. While kinematic studies focus on joint motion, kinetic studies focus on the loading and impact associated with motion of the joints.
Besides documenting specific biomechanical characteristics of the different stages of PTTD, it is essential to explore the relation of these biomechanical characteristics with the bone morphology of the involved osseous structures.
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. This will be done by simultaneously acquiring kinematic, kinetic and morphologic characteristics in PTTD patients, with a special interest in the possible connection between these morphological and the biomechanics changes. Through these insights, we will be able to better classify these patients, using the developed biomechanical classification, as a first step towards an optimized, patient-tailored treatment plan which converts these individual pathological characteristics back to normal, giving the patients back their mobility and a live without pain, i.e. gaining back their quality of life.
- Conditions
- Posterior Tibial Tendon Dysfunction
- Being tested
- Radiography, Ultrasound, MRI, CT-scan, Gait analysis
- Medical subject headings
- Posterior Tibial Tendon Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiographyDiagnostic test
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.
UltrasoundDiagnostic test
Ultrasound of the posterior tibial tendon to see if there is an irritation, elongation or rupture.
MRIDiagnostic test
MRI when ultrasound is not conclusive to identify an irritation, elongation or rupture of the posterior tibial tendon.
CT-scanDiagnostic test
CT-scan to identify arthritis of the tibial-talar, subtalar and/or Chopart joints.
Gait analysisDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| PTTD patients (PTTD I, II and III) | Experimental | 75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III) Receives: Diagnostic Test: Radiography; Diagnostic Test: Ultrasound; Diagnostic Test: MRI; Diagnostic Test: CT-scan; Diagnostic Test: Gait analysis |
| Healthy control group | Experimental | 25 healthy volunteers Receives: Diagnostic Test: Radiography; Diagnostic Test: CT-scan; Diagnostic Test: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (5)
American Orthopaedic Foot & Ankle Society (AOFAS) score
Patients Reported Outcome Measures. It combines five patient-reported items concerning pain and function with four physician-determined items concerning function and alignment, on a 0 to 100-point scale with healthy ankles receiving 100 points.
Measured: 1 year
European Foot and Ankle Society (EFAS) score
Patients Reported Outcome Measures consisting of six questions on pain and function. A total of 24 points can be achieved on a 5-point scale (0-4), whereby a high score means a good result.
Measured: 1 year
36-item Short Form Health Survey (SF36)
Patients Reported Outcome Measures that measures health-related quality of life and health care needs. The instrument includes scales for physical functioning, social functioning, role limitations due to physical or emotional problems, mental health, energy, pain and general health perception. A high score corresponds to better health status.
Measured: 1 year
Visual Analogue Scale (VAS) pain
Patients Reported Outcome Measures to quantify the pain of a patient. The VAS pain score runs from 10 to 0, where 10 is "Worst possible pain" and 0 is "No pain".
Measured: 1 year
Visual Analogue Scale (VAS) satisfaction
Patients Reported Outcome Measures to quantify the satisfaction of a patient. The VAS satisfaction score runs from 10 to 0, where 10 is "Very satisfied" and 0 is "unsatisfied".
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start22 Aug 2022
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Tibial Tendon DysfunctionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective interventional study that includes PTTD patients (PTTD I, II and III) and a healthy control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sander Wuite, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260813
- Sponsor's protocol ID
- S66277
- Acronym
- PTTD
- Status last verified
- Jul 2026
- First submitted
- 8 Dec 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No