Planning A Clinical Trial of Bio-enhanced ACL Repair versus ACL Reconstruction

计划生物增强 ACL 修复与 ACL 重建的临床试验

基本信息

  • 批准号:
    9233601
  • 负责人:
  • 金额:
    $ 44.45万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2017
  • 资助国家:
    美国
  • 起止时间:
    2017-03-01 至 2019-02-28
  • 项目状态:
    已结题

项目摘要

PROJECT SUMMARY ACL injuries affect over 400,000 patients each year. Our current best treatment is ACL reconstruction, where the torn ACL is removed and replaced with a graft of tendon harvested from another part of the knee. ACL reconstruction has a high rate of success in terms of returning patients to sport and activities of daily living. However, patients not only have to wait until the graft heals in, they also have to heal the area where the graft was harvested. Even with intense physical therapy, patients often still have as high as a 30% deficit in hamstring strength 6 months after a hamstring tendon graft is used. In addition, high rates of premature osteoarthritis - as high as 76% within 14 years of injury, are seen after ACL reconstruction, as well as high failure rates in adolescents. For this reason, new methods of treating ACL injuries are of interest. One such method is "Bridge-Enhanced ACL Repair (BEAR)", where a suture repair of the ACL is supplemented with a bioactive scaffold. In preclinical trials, this technique has shown equivalent results to ACL reconstruction in terms of mechanical stability of the joint and knees treated with bridge-enhanced repair had significantly less osteoarthritis than those treated with ACL reconstruction. With these promising preclinical results, we have obtained FDA approval and are currently conducting a 20-patient first-in-human study of the BEAR technique. With the promising results of that study, we now propose to conduct a 100-patient multicenter randomized controlled trial comparing the BEAR technique with ACL reconstruction. The work proposed in this U34 clinical trial planning grant application will allow us to select the appropriate number of sites to ensure timely enrollment, complete all protocols and regulatory materials, compete the self-report assessment tools, optimize the data management plan, enhance provider equipoise regarding enrollment and intervention delivery and complete surgical training for surgeons at all sites. The initial sites to be in the trial include Boston Children's Hospital, Ohio State University, Washington University St Louis and the Cleveland Clinic. Boston Children's Hospital is where the bridge-enhanced ACL repair technique has been developed and where the first-in-human trial is being conducted. Ohio State University, Washington University, and the Cleveland Clinic are all sites with a strong record of recruiting patients for ACL studies, including the Multicenter Orthopaedic Outcomes Network (MOON) studies. Through the collaborative effort of these sites, we will be able to design and prepare the documentation for a successful multi-site trial of a promising new treatment of bridge-enhanced ACL repair with our current gold standard of treatment, ACL reconstruction.
项目摘要 ACL损伤每年影响超过40万患者。我们目前最好的治疗方法是ACL 重建,其中撕裂的ACL被移除,并用收获的肌腱移植物替换 膝盖的另一部分。ACL重建在以下方面的成功率很高: 使患者恢复运动和日常生活活动。然而,患者不仅要等待 在移植物愈合之前,他们还必须治愈移植物被收获的区域。甚至 即使进行了强烈的物理治疗,患者的腿筋仍然有高达30%的缺陷, 使用腘绳肌腱移植物后6个月的强度。此外,早产率高, 骨关节炎-高达76%的14年内受伤,是看到后ACL重建, 以及青少年的高失败率。因此,治疗ACL损伤的新方法 很有意思一种这样的方法是“桥增强ACL修复(BEAR)",其中缝合线 ACL的修复补充有生物活性支架。在临床前试验中, 在关节的机械稳定性方面, 而接受桥接增强修复的膝关节骨关节炎明显少于接受桥接增强修复的膝关节, 进行ACL重建。 有了这些有希望的临床前结果,我们已经获得了FDA的批准,目前正在 进行了一项20名患者的BEAR技术的首次人体研究。随着有希望的结果 我们现在建议进行一项100例患者的多中心随机对照试验 比较BEAR技术与ACL重建。本U34临床研究中提出的工作 试验计划拨款申请将允许我们选择适当数量的网站,以确保 及时入组,完成所有方案和法规材料,完成自我报告 评估工具,优化数据管理计划,增强提供商在以下方面的平衡 所有研究中心的外科医生的入组和干预实施以及完整的手术培训。 最初的试验地点包括波士顿儿童医院,俄亥俄州州立大学, 华盛顿大学圣刘易斯和克利夫兰诊所。波士顿儿童医院 桥增强ACL修复技术已经开发出来, 审判正在进行中。俄亥俄州州立大学、华盛顿大学和克利夫兰诊所 是所有在ACL研究招募患者方面有良好记录的临床试验机构,包括多中心 骨科结局网络(MOON)研究。通过这些组织的共同努力, 研究中心,我们将能够设计和准备一个成功的多中心试验的文件, 一种有前途的新的治疗桥梁增强ACL修复与我们目前的黄金标准, 治疗ACL重建

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ monograph.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ sciAawards.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ conferencePapers.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ patent.updateTime }}

Braden C Fleming其他文献

Braden C Fleming的其他文献

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

{{ truncateString('Braden C Fleming', 18)}}的其他基金

Knee Arthrosis after ACL Reconstruction: A Long-term Cohort Study with Matched Controls
ACL 重建后的膝关节病:一项具有匹配对照的长期队列研究
  • 批准号:
    10159846
  • 财政年份:
    2019
  • 资助金额:
    $ 44.45万
  • 项目类别:
Knee Arthrosis after ACL Reconstruction: A Long-term Cohort Study with Matched Controls
ACL 重建后的膝关节炎:具有匹配对照的长期队列研究
  • 批准号:
    10424422
  • 财政年份:
    2019
  • 资助金额:
    $ 44.45万
  • 项目类别:
Non-invasive assessment of ligament healing in vivo
体内韧带愈合的无创评估
  • 批准号:
    8928046
  • 财政年份:
    2014
  • 资助金额:
    $ 44.45万
  • 项目类别:
Non-invasive assessment of ligament healing in vivo
体内韧带愈合的无创评估
  • 批准号:
    8759439
  • 财政年份:
    2014
  • 资助金额:
    $ 44.45万
  • 项目类别:
Non-invasive assessment of ligament healing in vivo
体内韧带愈合的无创评估
  • 批准号:
    9136641
  • 财政年份:
    2014
  • 资助金额:
    $ 44.45万
  • 项目类别:
RI COBRE: BIOENGINEERING CORE
RI COBRE:生物工程核心
  • 批准号:
    8360473
  • 财政年份:
    2011
  • 资助金额:
    $ 44.45万
  • 项目类别:
RI COBRE: BIOENGINEERING CORE
RI COBRE:生物工程核心
  • 批准号:
    8168033
  • 财政年份:
    2010
  • 资助金额:
    $ 44.45万
  • 项目类别:
Biologically Enhanced Healing of Autograft ACL Reconstruction.
自体移植 ACL 重建的生物增强愈合。
  • 批准号:
    8020913
  • 财政年份:
    2009
  • 资助金额:
    $ 44.45万
  • 项目类别:
Biologically Enhanced Healing of Autograft ACL Reconstruction.
自体移植 ACL 重建的生物增强愈合。
  • 批准号:
    8213690
  • 财政年份:
    2009
  • 资助金额:
    $ 44.45万
  • 项目类别:
RI COBRE: BIOENGINEERING CORE
RI COBRE:生物工程核心
  • 批准号:
    7959901
  • 财政年份:
    2009
  • 资助金额:
    $ 44.45万
  • 项目类别:

相似海外基金

Understanding How Adolescent Bullying Experiences Affect Traumatic Stress,Sexual Health and STI Risk among Men Who Have Sex with Men (MSM)
了解青少年欺凌经历如何影响男男性行为者 (MSM) 的创伤性压力、性健康和性传播感染风险
  • 批准号:
    10553263
  • 财政年份:
    2022
  • 资助金额:
    $ 44.45万
  • 项目类别:
Understanding How Adolescent Bullying Experiences Affect Traumatic Stress,Sexual Health and STI Risk among Men Who Have Sex with Men (MSM)
了解青少年欺凌经历如何影响男男性行为者 (MSM) 的创伤性压力、性健康和性传播感染风险
  • 批准号:
    10347813
  • 财政年份:
    2022
  • 资助金额:
    $ 44.45万
  • 项目类别:
Visuocortical Dynamics of Affect-Biased Attention in the Development of Adolescent Depression
青少年抑郁症发展过程中情感偏向注意力的视觉皮层动力学
  • 批准号:
    10380686
  • 财政年份:
    2019
  • 资助金额:
    $ 44.45万
  • 项目类别:
Visuocortical Dynamics of Affect-Biased Attention in the Development of Adolescent Depression
青少年抑郁症发展过程中情感偏向注意力的视觉皮层动力学
  • 批准号:
    9888437
  • 财政年份:
    2019
  • 资助金额:
    $ 44.45万
  • 项目类别:
Visuocortical Dynamics of Affect-Biased Attention in the Development of Adolescent Depression
青少年抑郁症发展过程中情感偏向注意力的视觉皮层动力学
  • 批准号:
    10597082
  • 财政年份:
    2019
  • 资助金额:
    $ 44.45万
  • 项目类别:
Targeting maladaptive responding to negative affect in adolescent cannabis users
针对青少年大麻使用者的负面影响的适应不良反应
  • 批准号:
    9371970
  • 财政年份:
    2017
  • 资助金额:
    $ 44.45万
  • 项目类别:
Childhood positive affect and anger as predictors of adolescent risky behavior
童年积极影响和愤怒是青少年危险行为的预测因素
  • 批准号:
    9139461
  • 财政年份:
    2015
  • 资助金额:
    $ 44.45万
  • 项目类别:
Do State Marijuana Policies Affect Adolescent Marijuana and Alcohol Use?
州大麻政策会影响青少年大麻和酒精的使用吗?
  • 批准号:
    8783159
  • 财政年份:
    2014
  • 资助金额:
    $ 44.45万
  • 项目类别:
Do State Marijuana Policies Affect Adolescent Marijuana and Alcohol Use?
州大麻政策会影响青少年大麻和酒精的使用吗?
  • 批准号:
    8853783
  • 财政年份:
    2014
  • 资助金额:
    $ 44.45万
  • 项目类别:
Assessment of Affect Instability in Adolescent Girls with BPD Features
具有 BPD 特征的青春期女孩的情绪不稳定评估
  • 批准号:
    8122499
  • 财政年份:
    2011
  • 资助金额:
    $ 44.45万
  • 项目类别:
{{ showInfoDetail.title }}

作者:{{ showInfoDetail.author }}

知道了