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临床试验/NCT04822558
NCT04822558招募中不适用

The Relevance of a 3D Multisegment Foot Model in Predicting and Determining the Clinical Outcome After Ankle and Hindfoot Reconstruction Procedures

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年3月1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
300
试验地点
1
主要终点
Gaitlab parameters

研究概览

简要总结

Most symptomatic pathologies of the ankle and hindfoot are determined by biomechanical alterations of this anatomical region. Surgical treatment of these pathologies is therefore aimed at improving the inferior biomechanical condition, and it can be expected that an improvement of the biomechanical parameters grossly parallels the targeted clinical improvement.

3D Multisegment Foot Models have been developed and validated to determine the clinical outcome. Such a validated 3D Multisegment Foot Model is now standard available in the gaitlab of UZ Leuven making it possible to study a huge amount of biomechanical parameters within the foot & ankle region itself.

详细描述

Most symptomatic pathologies of the ankle and hindfoot are determined by biomechanical alterations of this anatomical region. Surgical treatment of these pathologies is therefore aimed at improving the inferior biomechanical condition, and it can be expected that an improvement of the biomechanical parameters grossly parallels the targeted clinical improvement.

Unfortunately, in the past, biomechanical examination of the lower limb and foot consisted of two distinct study protocols: gaitlab and plantar pressure measurements.

First, these two study protocols were acquired completely independently. Therefore, it proved to be very hard to compare the results and get insight in the way altered biomechanics caused or continued to cause abnormal plantar pressure distributions. However, recently it was possible to integrate these two modalities, especially concerning the timing of the events, what makes it possible to reliably link the observed findings.

Second, virtually all gaitlab models considered the foot & ankle region as one single segment, making it impossible to evaluate any biomechanical parameter within the targeted region. 3D Multisegment Foot Models have been developed and validated since the beginning of this century. Such a validated 3D Multisegment Foot Model is now standard available in the gaitlab of UZ Leuven making it possible to study a huge amount of biomechanical parameters within the foot & ankle region itself.

Furthermore, only a paucity of information is available if the observed clinical changes are indeed paralleled by an equally directed biomechanical change.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Being routinely scheduled for a reconstructive surgical procedure for the following indications or involving the following type of procedure:
  • Any reconstructive procedure for Pes Planus, Pes Plano-valgus, or Posterior Tibial Tendon Dysfunction
  • Tibio-talar arthrodesis or prosthesis
  • Sub-talar -and/or (partial) Chopart - and/or Triple arthrodesis
  • Pantalar arthrodesis with or without inclusion of the Chopart joint

排除标准

  • Age under 18
  • Need of tools (eg walker or crutches) to walk less than 100m
  • Inability to walk less than 100 m anyway
  • Differences in leg length exceeding 3 cm (measured clinically)
  • Extreme in-or outtoeing
  • Subjects with BMI > 27.5 require very careful further consideration whether or not the obesity prevents the accurate palpation of anatomical landmarks necessary prior to marker placement. This will be judged on an individual basis.

研究组 & 干预措施

Ankle and hindfoot reconstruction surgery

Other

Patients who underwent an ankle- or hindfoot reconstruction surgery

干预措施: Plantar pressure measurement (Other)

Ankle and hindfoot reconstruction surgery

Other

Patients who underwent an ankle- or hindfoot reconstruction surgery

干预措施: Gait analysis (Other)

Ankle and hindfoot reconstruction surgery

Other

Patients who underwent an ankle- or hindfoot reconstruction surgery

干预措施: Ankle and hindfoot reconstruction surgery (Procedure)

结局指标

主要结局

Gaitlab parameters

时间窗: Pre-operative and at 1 year

To determine the correlation between the observed changes in gaitlab parameters and the observed changes at plantar pressure measurement and to determine if a clear correlation can be determined, comparing the pre- and post-operative results 3D multisegment foot model testing and clinical outcome

次要结局

  • 3D motion analysis: Gaitlab parameters to determine biomechanical parameters(Pre-operative and at 1 year)
  • Foot Function Index (FFI)(Pre-operative, at 6 months and at 1 year)
  • Short Form 36 Health Survey Questionnaire (SF-36)(Pre-operative, at 6 months and at 1 year)
  • Visual Analog Scale (VAS)(Pre-operative, at 6 months and at 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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