Off-Label Use in Orthopaedic Surgery

J Am Acad Orthop Surg. 2019 Sep 1;27(17):e767-e774. doi: 10.5435/JAAOS-D-18-00038.

Abstract

Surgeons frequently use orthopedic devices in an off-label manner. It is the responsibility of the surgeon to be familiar with the product and to use it based on scientific and clinical rationale. However, such practices are poorly publicized, and there remains paucity in the current literature surrounding the off-label use of orthopedic devices. Furthermore, the off-label use of devices is fraught with difficulty, including limitations in investigational studies and insurance reimbursement or coverage of use. Surgeons should be aware of the common off-label use in orthopedics. This review provides an overview of the off-label use in orthopedics and the obstacles associated with it; this review also offers clinical examples of its implementation.

Publication types

  • Review

MeSH terms

  • Device Approval
  • Evidence-Based Medicine
  • Humans
  • Joint Diseases / surgery*
  • Off-Label Use*
  • Orthopedic Equipment*
  • Orthopedic Procedures*
  • United States
  • United States Food and Drug Administration