Prospective Comparison of BioJoints versus Total and Unicompartmental Knee Arthroplasty

拟议的NIAMS临床试验计划补助金(R34)的目标是准备所有文件和活动 在提交U01临床试验实施合作协议之前是必要的 大段同种异体骨软骨移植(生物关节)修复生物关节的非劣势 膝关节置换术。BioJoint目前被批准用于55岁或以下的患者， 体重指数在35以下，活跃(或在关节问题之前活跃)，有局灶性全层软骨 缺陷。我们的团队已经开发并验证了BioJoints的技术和外科进展，这些进展 为患者扩大这种关节修复选择的适应症。然而，从来没有人有过头- 进展期关节软骨疾病两种手术治疗方案的比较 膝关节采用全临床试验研究设计。拟议的R34-以及未来的U01-旨在进行以下工作 比较，已经完成了必要的基础科学、临床前、临床和监管 显示材料和程序的安全性和有效性的组件。将召集一个专家小组，以 为在两个患者群体(45-55岁患者与 55-65岁)和适应症(传统和生物关节技术的单室/总/广泛) 最终的临床试验设计。将在每个年龄段进行初步的虚拟模特招募 基于过去五年我们诊所的先前患者和我们潜在的合作地点。另外， R34/U01团队将完成临床试验程序每个受试者成本的初步成本分析， 为临床试验开发材料-包括研究方案、IRB材料、数据收集资源、 患者教育和研究人员手册-并为U01制定预算。在R34的结束时 期间将与NIAMS合作提交U01进行临床试验，该试验将改变以下临床选择 患有晚期软骨疾病的患者，从而影响医疗、政策和实践。

The goal of the proposed NIAMS Clinical Trial Planning Grant (R34) is to prepare all documents and activities necessary prior to submitting a U01 Clinical Trial Implementation Cooperative Agreement investigating the non-inferiority of biologic joint restoration using large osteochondral allografts (BioJoint) to traditional arthroplasty in the knee. BioJoint is currently approved for use in patients who are aged 55 years or younger, have BMI under 35, are active (or were active prior to joint problems), and have focal full-thickness cartilage defects. Our team has developed and validated technologic and surgical advances for BioJoints that are expanding the indications for this joint restoration option for patients. However, there has never been a head- to-head comparison between the two surgical treatment options for advanced articular cartilage disorders of the knee using a full clinical trial research design. The proposed R34—and future U01—aim to undertake such a comparison, having already completed the necessary basic science, preclinical, clinical, and regulatory components showing safety and efficacy of the materials and procedures. An expert panel will be convened to provide guidance on designing a clinical trial on BioJoint in two patient populations (patients aged 45-55 versus 55-65 years) and indications (uni-compartmental versus total/extensive for traditional and BioJoint techniques) for the ultimate clinical trial design. Preliminary virtual model recruitment will be performed in each age group based on prior patients at our clinic and our potential collaborating sites over the past five years. Additionally, the R34/U01 team will complete a preliminary cost-analysis of per subject costs of the clinical trial procedures, develop materials for the clinical trial—including study protocols, IRB materials, data collection resources, patient education, and investigator brochures—and develop a budget for the U01. At the conclusion of the R34 period a U01 will be submitted in cooperation with NIAMS for a clinical trial that will alter clinical options for patients with advanced cartilage disease, thus affecting health care, policy, and practice.