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BION Treatment of Knee Osteoarthritis

2015年6月1日 更新者：Gerald E. Loeb, M.D.、University of Southern California

BION Implantable Microstimulator System

Osteoarthritic changes in the knee are a common cause of pain that restricts the subject's ability to move and may lead to surgical intervention with total knee replacement. Quadriceps muscle strengthening has been shown to improve the dynamic stability of the knee, decreasing pain during locomotion and increasing knee function. However, the gains associated with improved quadriceps strength have been difficult to achieve on a routine clinical basis because the currently available ways to increase muscle strength- through voluntary exercise or surface electrical stimulation- have significant practical problems that limit their use. The aim of this prospective study is to evaluate the safety and effectiveness of neuromuscular stimulation using implantable microstimulators called BIONs to improve the strength, range of motion, and health of the knee in patients with knee osteoarthritis. This investigation is expected to last 12 weeks for each study participant; the trial will be completed over a 3-year period. Patients recruited into the study will have advanced knee osteoarthritis for which total knee replacement surgery is being considered. The proposed study extends a feasibility study carried out in Milan, Italy on five patients with knee osteoarthritis, who were implanted with BIONs.

研究概览

地位

撤销

条件

干预/治疗

详细说明

Knee Osteoarthritis is a common problem with people over the age of 50 and is often debilitating because of the challenges it poses to normal walking function. Research has shown that exercise can lessen the effect of the osteoarthritis in the knee if done diligently. BION®s implanted in the thigh can produce contractions of the quadriceps muscles without much movement of the knee joint, an advantage if moving the knee is painful. In this study, teh subjects will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise.. In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises. All participants will be eligible to continue treatment following the initial 12 weeks if medically appropriate and resources permit.

研究类型

介入性

阶段

  • 阶段1

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

  • 美国
    • California
      • Los Angeles、California、美国、90033
        • USC University Hospital

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

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Subject presents with osteoarthritis of the knee with severity defined as Kellgren-Lawrence grade 3-4.
  2. Subject is between 18 and 75 years old.
  3. Attending physician considers the subject in general good health (other than knee joint osteoarthritis).
  4. Subject is mentally capable of understanding the goals and the application of therapy.
  5. Subject is able to apply the therapy (with or without help) in the home setting.
  6. Subject is willing and capable of giving informed consent.
  7. Subject is willing and capable of traveling to testing center at the schedule described above and detailed in Table 2.

Exclusion Criteria:

  1. Subject is pregnant, nursing, or planning to become pregnant in the next 12 months.
  2. Subject has an electronic implant (e.g. cardiac pacemaker, etc.).
  3. Subject has metallic implant (e.g. plates, hip joints) in the buttock or upper leg.
  4. Subject has a history of falling.
  5. Subject has medical conditions other than OA affecting the legs that could affect treatment or mobility.
  6. Subject is 40% or more above the ideal weight recommended by Metropolitan Life.
  7. Subject has cancer.
  8. Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention which would affect lower extremity mobility.
  9. Subject has bilateral knee osteoarthritis.
  10. Subject is taking pain medications with dosage not stable for one month.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：BION "twitch" stimulation
The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation.
设备：BION

They will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise.

In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises.
实验性的：BION tetanic-frequency stimulation
The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions.
设备：BION

They will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise.

In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises.
无干预：Standardized program
A third group of experimental subjects will have a standardized program of voluntary exercise.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
quadriceps isometric strength
大体时间：pre-exercise, 4w, 8w, 12w
pre-exercise, 4w, 8w, 12w

次要结果测量

结果测量
大体时间
Gait velocity Gait endurance Pain WOMAC
大体时间：pre-exercise, 8w, 12w
pre-exercise, 8w, 12w

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。

赞助

University of Southern California

调查人员

  • 首席研究员：Lucinda Baker, Ph.D、University of Southern California

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。

一般刊物

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

2008年4月1日

初级完成 (实际的)

2008年12月1日

研究完成 (实际的)

2008年12月1日

研究注册日期

首次提交

2008年5月29日

首先提交符合 QC 标准的

2008年5月29日

首次发布 (估计)

2008年6月3日

研究记录更新

最后更新发布 (估计)

2015年6月3日

上次提交的符合 QC 标准的更新

2015年6月1日

最后验证

2015年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BT5

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.

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条件

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