Biomechanical and Morphological Characterization of PTTD
- Conditions
- Posterior Tibial Tendon Dysfunction
- Interventions
- Diagnostic Test: RadiographyDiagnostic Test: UltrasoundDiagnostic Test: Gait analysisDiagnostic Test: MRIDiagnostic Test: CT-scan
- Registration Number
- NCT06260813
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy control group Radiography 25 healthy volunteers Healthy control group Gait analysis 25 healthy volunteers PTTD patients (PTTD I, II and III) Radiography 75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III) PTTD patients (PTTD I, II and III) Ultrasound 75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III) PTTD patients (PTTD I, II and III) Gait analysis 75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III) PTTD patients (PTTD I, II and III) MRI 75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III) PTTD patients (PTTD I, II and III) CT-scan 75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III) Healthy control group CT-scan 25 healthy volunteers
- Primary Outcome Measures
Name Time Method Power generation during Gait analysis 1 year 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.
Kinematic characteristics during Gait analysis 1 year 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.
Bone morphology 1 year 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.
Moment during Gait analysis 1 year 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.
Center of pressure during Gait analysis 1 year 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.
Angular velocity during Gait analysis 1 year 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.
Power absorption during Gait analysis 1 year 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.
- Secondary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) pain 1 year 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".
American Orthopaedic Foot & Ankle Society (AOFAS) score 1 year 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.
European Foot and Ankle Society (EFAS) score 1 year 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.
36-item Short Form Health Survey (SF36) 1 year 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.
Visual Analogue Scale (VAS) satisfaction 1 year 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".
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium