Clinical trial NCT06260813: Biomechanical and Morphological Characterization of PTTD
Official title: Biomechanical and Morphological Characterization of the Foot in Patients With Posterior Tibial Tendon Dysfunction.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posterior Tibial Tendon Dysfunction
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective interventional study that includes PTTD patients (PTTD I, II and III) and a healthy control group.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Kinematic characteristics during Gait analysis
timeFrame: 1 year
measure: Center of pressure during Gait analysis
timeFrame: 1 year
measure: Angular velocity during Gait analysis
timeFrame: 1 year
measure: Moment during Gait analysis
timeFrame: 1 year
measure: Power absorption during Gait analysis
timeFrame: 1 year
measure: Power generation during Gait analysis
timeFrame: 1 year
measure: Bone morphology
timeFrame: 1 year
Secondary outcomes:
measure: American Orthopaedic Foot & Ankle Society (AOFAS) score
timeFrame: 1 year
measure: European Foot and Ankle Society (EFAS) score
timeFrame: 1 year
measure: 36-item Short Form Health Survey (SF36)
timeFrame: 1 year
measure: Visual Analogue Scale (VAS) pain
timeFrame: 1 year
measure: Visual Analogue Scale (VAS) satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Sander Wuite
role: PRINCIPAL_INVESTIGATOR
References: