Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.

Alexander R Willis,Kathleen S Beebe,Joseph Benevenia,Francis R Patterson,Joseph A Ippolito

doi:10.1186/s40064-016-2696-1

Abstract

BackgroundCustomizable 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.PurposeThe 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.MethodsAn 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.ResultsThe 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.ConclusionsEstablishment 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.Level of evidenceRetrospective case series, Level IV. See the Guidelines for authors for a complete description of levels of evidence.

Highlights

Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems
An institutional protocol for obtaining Institutional Review Board (IRB) and Food and Drug Administration (FDA) approval for customizable orthopaedic implants was established with the IRB at our institution in 2013
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

Summary

Introduction

Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Malignant primary bone tumors are rare entities with an incidence of approximately 0.8/100,000 people per Willis et al SpringerPlus (2016) 5:967. When a malignant primary bone tumor is diagnosed, patients often require extensive surgery and removal of large portions of their skeletal structure along with the tumor. More recent advances have made limb salvage surgery feasible (Lewis 1985; Link et al 1986). These procedures require significant pre-operative planning, part of which includes obtaining an implant appropriate for the patient’s size, anatomy, and defect created by the surgery

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