Willis Alexander R, Ippolito Joseph A, Patterson Francis R, Benevenia Joseph, Beebe Kathleen S
Monmouth Medical Center, Long Branch, NJ 07740 USA.
Department of Orthopaedic Surgery, Rutgers New Jersey Medical School, 140 Bergen Street, ACC Building, Suite D-1610, Newark, NJ 07103 USA.
Springerplus. 2016 Jul 4;5(1):967. doi: 10.1186/s40064-016-2696-1. eCollection 2016.
Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient's surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place.
The objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol.
An institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013-2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval.
The average patient age was 12 years old (7-21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7-21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7-19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act's expanded access provisions.
Establishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated process of obtaining customizable orthopaedic implants for orthopaedic oncology patients.
Retrospective case series, Level IV. See the Guidelines for authors for a complete description of levels of evidence.
由于独特的解剖结构或复杂的力学问题，原发性恶性骨肿瘤患者通常需要定制的骨科植入物。目前，为骨科肿瘤患者获取定制的骨科植入物可能是一项艰巨的任务，涉及向机构审查委员会（IRB）和食品药品监督管理局（FDA）提交审批申请。如果提交途径被误解或没有简化的方案，患者手术很可能会延迟，并且会产生不必要的文书工作。
本研究的目的是回顾FDA现有的定制植入物审批途径，并确定通过机构方案是否能改进这一过程。
2013年，我们机构与IRB制定了一项关于获得IRB和FDA对定制骨科植入物批准的机构方案。该方案经IRB批准，因此新患者只需提交对现有方案的修改并附上个体化患者信息。在2013 - 2014年的两年期间，回顾性确定8例患者在各种骨科肿瘤手术中需要定制植入物。记录IRB批准申请日期、FDA批准申请日期、手术总时间，以及FDA批准所采用的具体途径。
患者平均年龄为12岁（7 - 21岁）。对预先批准方案的修改获得IRB批准的平均时间为14天（7 - 21天）。向制造商提交IRB批准后获得FDA批准的平均时间为12.5天（7 - 19天）。根据《联邦食品药品和化妆品法案》扩大使用条款第561节，所有植入物均作为同情用药申请获得FDA批准。
建立经IRB预先批准的机构方案可以加快为骨科肿瘤患者获取定制骨科植入物这一原本耗时且复杂的过程。
回顾性病例系列，IV级。有关证据水平的完整描述，请参见作者指南。
