Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06260813 |
| Other study ID # |
S66277 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 22, 2022 |
| Est. completion date |
August 1, 2028 |
Study information
| Verified date |
December 2023 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
Sander Wuite |
| Phone |
+32 16 33 83 29 |
| Email |
sander.wuite[@]uzleuven.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
