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临床试验/NCT06260813
NCT06260813招募中不适用

Biomechanical and Morphological Characterization of the Foot in Patients With Posterior Tibial Tendon Dysfunction.

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Power generation during Gait analysis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

PTTD patients (PTTD I, II and III) and a healthy control group.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

PTTD patients (PTTD I, II and III)

Experimental

75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III)

干预措施: CT-scan (Diagnostic Test)

PTTD patients (PTTD I, II and III)

Experimental

75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III)

干预措施: Ultrasound (Diagnostic Test)

PTTD patients (PTTD I, II and III)

Experimental

75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III)

干预措施: MRI (Diagnostic Test)

PTTD patients (PTTD I, II and III)

Experimental

75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III)

干预措施: Gait analysis (Diagnostic Test)

Healthy control group

Experimental

25 healthy volunteers

干预措施: Radiography (Diagnostic Test)

Healthy control group

Experimental

25 healthy volunteers

干预措施: CT-scan (Diagnostic Test)

Healthy control group

Experimental

25 healthy volunteers

干预措施: Gait analysis (Diagnostic Test)

PTTD patients (PTTD I, II and III)

Experimental

75 patients with PTTD (25 patients in Stage I, 25 patients in Stage II, 25 patients in Stage III)

干预措施: Radiography (Diagnostic Test)

结局指标

主要结局

Power generation during Gait analysis

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Visual Analogue Scale (VAS) pain(1 year)
  • American Orthopaedic Foot & Ankle Society (AOFAS) score(1 year)
  • European Foot and Ankle Society (EFAS) score(1 year)
  • 36-item Short Form Health Survey (SF36)(1 year)
  • Visual Analogue Scale (VAS) satisfaction(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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