Anterior Heel Wedge to Treat Flexion Contracture After Total Knee Arthroplasty
2026年5月26日 更新者:Abbey Thomas, PhD、University of North Carolina, Charlotte
Efficacy of Anterior Heel Wedge at Reducing Knee Flexion Contracture After Total Knee Arthroplasty: A Pilot Investigation
Total knee arthroplasty (TKA) remains the only treatment for end-stage knee osteoarthritis, whereby the diseased ends of the bones comprising the knee joint are removed and replaced with prosthetic joint components.
Approximately 500,000 of these procedures are performed annually in the United States.
Despite an otherwise successful procedure and post-operative rehabilitation process, about 5% of all individuals will develop a flexion contracture after TKA.
Flexion contracture limits the knee joint range of motion, which has negative impacts on activities of daily living and health-related quality of life.
Standard of care treatment for resolving flexion contracture requires more surgery or, at minimum, more exposure to anesthesia to manipulate the joint and improve range of motion.
The investigators have developed a non-invasive means for resolving flexion contracture, The investigators propose fixing a wedge to the sole of the patient's shoe such that the taller end of the wedge is located near the toes and the shorter end is closer to the heel.
Biomechanically, this forces the individual to make ground contact during walking closer to the heel rather than the toes (which is typically observed in patients with flexion contracture).
By forcing ground contact closer to the heel, patients gradually force their knee to extend (straighten) over time and resolve the flexion contracture.
The aim of this pilot investigation is to test the hypothesis that the anterior wedge worn on the shoe during all walking activities for 4 weeks will reduce the severity of the flexion contracture in patients after TKA.
研究概览
研究类型
介入性
注册 (实际的)
8
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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North Carolina
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Charlotte、North Carolina、美国、28269
- UNC Charlotte
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- over the age of 18 years
- underwent primary, unilateral TKA and approved for participation by surgeon
- present with flexion contracture in the operative limb (5 degrees or greater at least 3 months after surgery)
- body mass index <40kg/m^2
Exclusion Criteria:
- underwent revision TKA
- underwent bilateral TKA
- require use of assistive device to walk
- inability to consistently comprehend and repeat back directions, including for reasons of not understanding/speaking English
- current smoker
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Orthotic
Participants enrolled in this arm wear an anterior heel wedge, in the form of a shoe orthotic, to improve walking and reduce knee flexion contracture.
The wedge is worn continuously on the shoe for 1 month.
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A continuously-worn shoe anterior heel wedge that fits on the under surface of the shoe just under the toe box.
When worn during walking, the anterior heel wedge may help to increase knee joint range of motion and reduce knee flexion contracture in patients after total knee arthroplasty.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gait biomechanics
大体时间:From enrollment to the end of treatment at 4 weeks
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Participants will walk over level ground at a self-selected pace and one equivalent to average older adult walking speed.
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From enrollment to the end of treatment at 4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-reported outcomes
大体时间:From baseline to the end of the intervention at 4 weeks
|
Participants will complete the Knee Osteoarthritis Outcomes Survey (0-100, higher scores are better).
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From baseline to the end of the intervention at 4 weeks
|
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Patient-reported outcomes
大体时间:From baseline to the end of the intervention at 4 weeks
|
Participants will complete a Global rating of change (-7 to 7, higher scores indicate more positive changes).
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From baseline to the end of the intervention at 4 weeks
|
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Patient-reported outcomes
大体时间:From baseline to the end of the intervention at 4 weeks
|
Participants will complete the VR-12 (0-100 with higher scores indicating more optimal physical and mental well-being) .
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From baseline to the end of the intervention at 4 weeks
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Patient-reported outcomes
大体时间:From baseline to the end of the intervention at 4 weeks
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Participants will complete the International Physical Activity Questionnaire- Short Form (0- no max possible, higher scores indicate greater levels of physical activity).
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From baseline to the end of the intervention at 4 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年3月16日
初级完成 (实际的)
2025年12月31日
研究完成 (实际的)
2025年12月31日
研究注册日期
首次提交
2024年12月19日
首先提交符合 QC 标准的
2026年5月26日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年5月26日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.