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临床试验/NCT03157141
NCT03157141Unknown不适用

Ankle Osteoarthritis and Its Treatments : Impact on Foot & Ankle Biomechanics

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Force-time impulses (N.s)

研究概览

简要总结

Ankle osteoarthritis is a progressive degenerative joint disease that is characterized by severe pain, loss of autonomy, diminished health-related quality of life, functional disability and diminished physical ability to fulfill occupational duties of life in its end-stage. Current surgical treatments for ankle osteoarthritis are ankle arthrodesis and total ankle replacement. Despite the good pain relief provided by these procedures, patients are still experiencing post-operatively important functional limitations in their activities of the daily living which affect their independency and quality of life. In order to remain capable of performing primary activities of the daily living, those patients have to make functional compensatory adaptations in the ipsilateral adjacent joints that will cause additional degenerative joint disease in those joints.

Currently, the outcome of foot and ankle surgery is primarily based on clinical, radiographic and questionnaire outcomes. However, these outcome measures have been criticized for not being sensitive enough to detect clinically meaningful change in foot function. To tackle these shortcomings, an advanced clinical examination platform integrating pressure-force-kinematic measurement devices was developed and showed its clinical value for the detection of intrinsic foot mobility impairments. Surprisingly, up-to-now, no study has included this integrated use of three-dimensional multi-segment foot models, plantar pressure platform and a force platform to report on the functional outcome of an ankle arthrodesis or a total ankle replacement.

Therefore, a multi-centre study will be conducted with two foot & ankle surgery centres. Both centres are equipped with the same advanced clinical examination platform. It is believed that proposed approach has the potential to provide further insight in the true functional changes related to ankle arthrodesis and total ankle replacement. This may in turn result in improved rehabilitation, less risk for post-operative complications, earlier discharge and quicker resumption of normal activities of the daily living, which would make ankle arthrodesis and total ankle replacement more cost-efficient and could potentially affect thousands of patients each year. Therefore, the hypotheses of the present study are:

  • Hypothesis (H1): Subjects with an ankle arthrodesis require a greater reorganization of foot and lower limb kinematic and kinetic patterns to respond to mechanical requirements of level walking compared to subjects with a total ankle replacement.
  • Null hypothesis (H0): Subjects with an ankle arthrodesis do not require a greater reorganization of foot and lower limb kinematic and kinetic patterns to respond to mechanical requirements of level walking compared to subjects with a total ankle replacement.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary osteoarthritis
  • post-traumatic osteoarthritis with an aligned or partially reducible deformity of the ankle and/or hindfoot

排除标准

  • history of orthopaedic lower limb surgery except for the ankle
  • neuromuscular disorders
  • vascular insufficiency
  • significant skin conditions such as skin ulcers or skin grafts

结局指标

主要结局

Force-time impulses (N.s)

时间窗: Change from baseline (preoperative) to 24 months post-operatively

Force-time impulse is used to evaluate the effectiveness of a treatment at a specific foot location

Joint moments (N.m/kg)

时间窗: Change from baseline (preoperative) to 24 months post-operatively

3D multisegment foot kinetic model will allow to quantify mechanical loading of intrinsic foot joints during barefoot walking.

Foot and lower limb kinematics (degrees).

时间窗: change from baseline (preoperative) to 24 months post-operatively

The Rizzoli 3D multi-segment foot model and the Rizzoli 3D lower limb model will be used to calculate changes pre-and post-operative foot and lower limb kinematics during barefoot walking.

Power (W/kg)

时间窗: Change from baseline (preoperative) to 12 months post-operatively

3D multisegment foot kinetic model will allow to quantify mechanical loading of intrinsic foot joints during barefoot walking.

次要结局

  • Demographic data(pre-operatively)
  • Mechanical axis of the foot and lower limb (degrees)(pre-operatively)
  • Position of the ankle arthrodesis or of the ankle prosthesis (degrees)(Change from baseline (preoperative) to 12 months post-operatively)
  • Health-related quality of life (SF-36)(Change from baseline (preoperative) to 24 months post-operatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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