title: Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  METHODS
  Retrospective case series, Level IV. See the Guidelines for authors for a complete description of levels of evidence.
authors.affiliation: Monmouth Medical Center, Long Branch, NJ 07740 USA.
authors.forename: Alexander R
authors.initials: AR
authors.lastname: Willis
authors.affiliation: Department of Orthopaedic Surgery, Rutgers New Jersey Medical School, 140 Bergen Street, ACC Building, Suite D-1610, Newark, NJ 07103 USA.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Ippolito
authors.affiliation: Department of Orthopaedic Surgery, Rutgers New Jersey Medical School, 140 Bergen Street, ACC Building, Suite D-1610, Newark, NJ 07103 USA.
authors.forename: Francis R
authors.initials: FR
authors.lastname: Patterson
authors.affiliation: Department of Orthopaedic Surgery, Rutgers New Jersey Medical School, 140 Bergen Street, ACC Building, Suite D-1610, Newark, NJ 07103 USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Benevenia
authors.affiliation: Department of Orthopaedic Surgery, Rutgers New Jersey Medical School, 140 Bergen Street, ACC Building, Suite D-1610, Newark, NJ 07103 USA.
authors.forename: Kathleen S
authors.initials: KS
authors.lastname: Beebe