Off-Label Use in Orthopaedic Surgery.

J Am Acad Orthop Surg · Sep 01 2019 · Review

Taylor BC, Triplet JJ, El-Sabawi T

From the Department of Orthopedic Surgery, Grant Medical Center (Dr. Taylor and Dr. Triplet), and the Division of…

General Orthopaedics

SUMMARY — THE REDUCTIONOff-label device use in orthopedics is common but faces regulatory and reimbursement barriers; surgeons must ensure scientific rationale.
Abstract, as published

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.

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