Biomechanical and Morphological Characterization of PTTD
ConditionPosterior Tibial Tendon Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Posterior tibial tendon dysfunction (all clinical stages)
Age 18-675 year
ICF obtained
No pain complaints
Disqualifiers
Being younger than 18 years
Inability to walk without mobility aids
Inability to walk < 100 meter
Difference in leg length > 3cm
Trial design
Design model
Parallel
Treatments tested in this trial
Radiography
Diagnostic testX-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
Diagnostic testUltrasound of the posterior tibial tendon to see if there is an irritation, elongation or rupture.
MRI
Diagnostic testMRI when ultrasound is not conclusive to identify an irritation, elongation or rupture of the posterior tibial tendon.
CT-scan
Diagnostic testCT-scan to identify arthritis of the tibial-talar, subtalar and/or Chopart joints.
Gait analysis
Diagnostic testThis 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PTTD patients (PTTD I, II and III)Experimental treatment 5 interventions
Group B: Healthy control groupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year2
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.
Time frame
1 year3
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.
Time frame
1 year4
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.
Time frame
1 yearSecondary outcomes
1
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.
Time frame
1 year2
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.
Time frame
1 year3
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.
Time frame
1 year4
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".
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov