Prospective Comparison of BioJoints versus Total and Unicompartmental Knee Arthroplasty

拟议的NIAMS临床试验规划补助金（R34）的目标是准备所有文件和活动 在提交U 01临床试验实施合作协议之前， 使用大型骨软骨同种异体移植物（BioJoint）进行生物关节修复的非劣效性 膝关节置换术BioJoint目前被批准用于55岁或以下的患者， BMI低于35，活跃（或在关节问题之前活跃），并且有局灶性全层软骨 缺陷我们的团队已经开发并验证了BioJoints的技术和手术进步， 为患者扩大这种关节修复选择的适应症。然而，从来没有一个头- 两种手术治疗晚期关节软骨疾病的方法比较 使用完整的临床试验研究设计。拟议的R34--以及未来的U 01--旨在承担这样的任务， 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， 提供了在两个患者人群中设计BioJoint临床试验的指导（45-55岁的患者与 55-65岁）和适应症（传统和BioJoint技术的单室与全室/广泛） 最终的临床试验设计。将在每个年龄组进行初步的虚拟模特招募 基于过去五年来我们诊所和我们潜在合作地点的既往患者。此外，本发明还 R34/U 01团队将完成临床试验程序每例受试者成本的初步成本分析， 开发临床试验材料-包括研究方案、IRB材料、数据收集资源， 患者教育和研究者手册，并为U 01制定预算。在R34结束时 期间，将与NIIMS合作提交U 01进行临床试验，该试验将改变临床选择， 晚期软骨疾病患者，从而影响医疗保健，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.