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

• 批准号: 9233601
• 负责人: Braden C Fleming
• 金额: $ 44.45万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 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
• 来源: https://reporter.nih.gov/project-details/9233601
• 关键词: Activities of Daily Living; Adolescent; Affect; Anterior Cruciate Ligament; Applications Grants; Area; Assessment tool; Autologous Transplantation; Award; Boston; Cadaver; Clinic; Clinical Trials; Consent; Data; Databases; Degenerative polyarthritis; Development; Documentation; Eligibility Determination; Engineering; Enrollment; Ensure; Equipoise; FDA approved; Face; Failure; Family suidae; Funding; Gold; Grant; Harvest; Human; Injury; Institutional Review Boards; Intervention; Joints; Knee; Knee bone; Lead; Ligaments; Manuals; Mechanics; Methods; Modeling; Monitor; ORALIT; Ohio; Operative Surgical Procedures; Orthopedics; Outcome; Patient Outcomes Assessments; Patient Recruitments; Patient Self-Report; Patients; Pediatric Hospitals; Peer Review; Physical therapy; Physicians; Pilot Projects; Positioning Attribute; Postoperative Period; Preclinical Testing; Procedures; Protocols documentation; Provider; Publications; Questionnaires; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recovery; Reproducibility; Research; Research Personnel; Resources; Respondent; Safety; Site; Site Visit; Sports; Surgeon; Surgical sutures; System; Techniques; Tendon structure; Testing; Time; Tissue Engineering; Training; Training and Infrastructure; United States National Institutes of Health; Universities; Washington; Work; anterior cruciate ligament reconstruction; arm; bone; clinical research site; clinically relevant; cohort; data management; design; evidence base; graft healing; hamstring; healing; human study; innovation; instrument; interest; mechanical properties; meetings; multi-site trial; novel; patellar tendon; pre-clinical; preclinical trial; premature; prospective; quadriceps muscle; reconstruction; repaired; scaffold; standard care; success; tibia; trial comparing

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40万名患者。我们目前的最佳治疗方法是ACL 重建，其中撕裂的ACL被去除并用收获的肌腱接枝代替 从膝盖的另一部分。 ACL重建在 将患者返还运动和日常生活活动。但是，患者不仅需要等待 在移植物愈合之前，他们还必须治愈收获移植物的区域。甚至 通过严格的物理疗法，患者的腿筋差异通常还高30％ 使用腿筋肌腱移植后6个月的强度。此外，过早的率很高 骨关节炎 - ACL重建后14年内高达76％，如 以及青少年的高失败率。因此，治疗ACL损伤的新方法 很感兴趣。一种这样的方法是“桥梁增强的ACL修复（熊）”，其中缝合 ACL的维修补充了生物活性支架。在临床前试验中，这项技术 根据关节的机械稳定性，已显示出与ACL重建的等效结果 用桥梁增强修复治疗的膝盖的骨关节炎明显少于 用ACL重建治疗。 通过这些有希望的临床前结果，我们获得了FDA的批准，目前是 对熊技术进行20名患者的人类研究。有希望的结果 在这项研究中，我们现在建议进行100名患者多中心随机对照试验 将熊技术与ACL重建进行比较。 U34临床中提出的工作 审判计划赠款申请将使我们能够选择适当数量的站点以确保 及时入学，完成所有协议和监管材料，竞争自我报告 评估工具，优化数据管理计划，增强提供商的设备 所有部位的外科医生的注册和干预交付以及完整的外科手术培训。 审判中的最初站点包括​​俄亥俄州立大学波士顿儿童医院， 华盛顿大学圣路易斯和克利夫兰诊所。波士顿儿童医院是 桥梁增强的ACL维修技术已经开发 正在进行审判。俄亥俄州立大学，华盛顿大学和克利夫兰诊所 所有的地点都有招募患者进行ACL研究的良好记录，包括多中心 骨科结果网络（月球）研究。通过这些合作的努力 网站，我们将能够设计和准备文档，以成功地进行多站点试验 我们目前的金标准的有希望的新的桥梁增强ACL修复 治疗，ACL重建。