Antero-Posterior Knee Stability
2017年12月29日 更新者：David F. Scott, MD
Antero-Posterior Knee Stability With Medial-Pivot, Cruciate-Substituting, and Posterior-Stabilized Total Knee Arthroplasty: A Retrospective Study
A retrospective one-time evaluation of total knee patients one year or more postoperative, to compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and clinical outcomes.
Multiple implant brand/models will be included in the study.
研究概览
研究类型
观察性的
注册 (实际的)
100
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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Washington
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Spokane、Washington、美国、99218
- Spokane Joint Replacement Center
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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
21年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Internal database of prior total knee replacement patients.
描述
Inclusion Criteria:
- Patients willing to sign the informed consent.
- Patients able to comply with study requirements including stress x-rays and self-evaluations.
- Male and non-pregnant females ages 21 - 80 years of age at the time of surgery.
- Patients who have undergone a primary total knee replacement, are one year or greater postoperative, and are not having any evidence of failure of their implants.
- Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- Patients with intact collateral ligaments.
- Range of motion within five degrees of full extension and a minimum of 120 degrees of flexion.
Exclusion Criteria:
- Patients with inflammatory arthritis.
- Patients that are morbidly obese, body mass index (BMI) > 40.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
- Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers.
- Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
- Patients with knee fusion to the affected joint.
- Patients with an active or suspected latent infection in or about the knee joint.
- Patients that are prisoners.
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
- 观测模型：队列
- 时间观点：其他
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Medial-Pivot Knee Prosthesis
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Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
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Posterior-Stabilized Knee Prosthesis
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Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
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Cruciate-Stubstituting Knee Prosthesis
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Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
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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 |
|---|---|---|
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Measurement of antero-posterior stability of the knee with stress x-rays.
大体时间：1 year post-operative
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Antero-posterior stability of the knee will be measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion.
Stress x-rays will be obtained during a single visit for subjects 1 year or greater post-operatively.
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1 year post-operative
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Knee Society Score (KSS)
大体时间：1 year post-operative
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Clinical outcomes will be evaluated via the Knee Society Score (KSS) obtained during a single visit for subjects 1 year or greater post-operatively.
The KSS is subdivided into a Knee Assessment score which rates only the knee joint itself, and a Functional Assessment score which rates the subject's ability to walk and climb stairs.
Both scores range from 0-100, with a higher score indicating a better outcome.
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1 year post-operative
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Lower Extremity Activity Scale (LEAS)
大体时间：1 year post-operative
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Clinical outcomes will be evaluated via the Lower Extremity Activity Scale (LEAS) obtained during a single visit for subjects 1 year or greater post-operatively.
The LEAS scale range is 1-18, with a higher value indicating a higher level of activity.
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1 year post-operative
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Forgotten Joint Score (FJS)
大体时间：1 year post-operative
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Clinical outcomes will be evaluated via the Forgotten Joint Score (FJS) obtained during a single visit for subjects 1 year or greater post-operatively.
The FJS total score range is 0-100, with higher scores indicating a higher degree of "forgetting" the artificial joint, that is, a lower degree of awareness.
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1 year post-operative
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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。
调查人员
- 首席研究员：David F Scott, MD、Spokane Joint Replacement Center
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)
2016年1月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2017年12月1日
研究注册日期
首次提交
2017年12月11日
首先提交符合 QC 标准的
2017年12月29日
首次发布 (实际的)
2018年1月2日
研究记录更新
最后更新发布 (实际的)
2018年1月2日
上次提交的符合 QC 标准的更新
2017年12月29日
最后验证
2017年12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.
Stress X-Ray的临床试验
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Bayer完全的
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Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Brain & Behavior Research... 和其他合作者招聘中
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World BankAddis Ababa University; Ethiopian Medical Association; Policy Studies Institute招聘中
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University Hospital, Clermont-Ferrand完全的
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The University of Hong KongLondon School of Hygiene and Tropical Medicine; Nagasaki University邀请报名