protocolSection identificationModule nctId: NCT06260813, orgStudyIdInfo id: S66277, briefTitle: Biomechanical and Morphological Characterization of PTTD, acronym: PTTD, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-22, primaryCompletionDateStruct date: 2028-08-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Posterior Tibial Tendon Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective interventional study that includes PTTD patients (PTTD I, II and III) and a healthy control group., primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: PTTD patients (PTTD I, II and III) and a healthy control group., whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Radiography, interventions name: Ultrasound, interventions name: MRI, interventions name: CT-scan, interventions name: Gait analysis, outcomesModule primaryOutcomes measure: Kinematic characteristics during Gait analysis, primaryOutcomes measure: Center of pressure during Gait analysis, primaryOutcomes measure: Angular velocity during Gait analysis, primaryOutcomes measure: Moment during Gait analysis, primaryOutcomes measure: Power absorption during Gait analysis, primaryOutcomes measure: Power generation during Gait analysis, primaryOutcomes measure: Bone morphology, secondaryOutcomes measure: American Orthopaedic Foot & Ankle Society (AOFAS) score, secondaryOutcomes measure: European Foot and Ankle Society (EFAS) score, secondaryOutcomes measure: 36-item Short Form Health Survey (SF36), secondaryOutcomes measure: Visual Analogue Scale (VAS) pain, secondaryOutcomes measure: Visual Analogue Scale (VAS) satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Sander Wuite, role: CONTACT, phone: +32 16 33 83 29, email: sander.wuite@uzleuven.be, contacts name: Kevin Deschamps, role: CONTACT, phone: +32 16 33 88 27, email: kevin.deschamps@uzleuven.be, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False