Third Place Award Off-label versus on-label outcomes of total joint arthroplasty

Jane, Liu; Small, Travis; Masch, Jessica; Goldblum, Andrew; Klika, Alison K.; Barsoum, Wael K.

doi:10.1097/bco.0000000000000396

Cited by 2 publications

(2 citation statements)

References 12 publications

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“…39 Given the inherent limitations of this study, the primary goal was to identify trends of off-label hip and knee arthroplasty on a national scale. Liu et al 40,33 reported off-label use in 154 of 225 (68%) of THA and TKA patients at a single, academic tertiary medical center. Despite potential inadequacies in identification, our results confirm widespread off-label use nationwide.…”

Section: Discussionmentioning

confidence: 99%

Prevalence and Perioperative Outcomes of Off-Label Total Hip and Knee Arthroplasty in the United States, 2000–2010

Malcolm¹,

Szubski²,

Schiltz³

et al. 2015

The Journal of Arthroplasty

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“ Off-label use” refers to medical device utilization for purposes or subpopulations other than those approved by the United States Food and Drug Administration. The primary goal of this study was to determine the current epidemiology of off-label total hip and knee arthroplasty (THA and TKA, respectively) in the United States and to project further off-label use through 2040. Over the past decade, the prevalence of off-label THA and TKA was 30.4% and 37.0%, respectively, growing ~70% from 2000 2010. By 2040, the majority of THA (86.1%) and TKA (91.5%) could be off-label. The high prevalence of off-label arthroplasty and the dramatically shifting patient profile illustrated by these results highlight the need for continued medical device surveillance among on-and off label patients.

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Section: Discussionmentioning

confidence: 99%

Prevalence and Perioperative Outcomes of Off-Label Total Hip and Knee Arthroplasty in the United States, 2000–2010

Malcolm¹,

Szubski²,

Schiltz³

et al. 2015

The Journal of Arthroplasty

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“…It was also reported that with increased incidence of comorbidities the off-label rate rose annually for each procedure type during the investigated decade. Liu et al, 8 in a single-institution study, evaluated the incidence and outcomes between patients with implants used on- and off-label. They found that, by current definition, of the 225 patients surveyed (92 hips and 133 knees), 154 patients (68.4%) had off-label implants.…”

Section: Recommendationsmentioning

confidence: 99%

EFORT recommendations for off-label use, mix & match and mismatch in hip and knee arthroplasty

Tucker¹,

Günther

Kjærsgaard‐Andersen

et al. 2021

EFORT Open Reviews

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Off-label use is frequently practiced in primary and revision arthroplasty, as there may be indications for the application of implants for purposes outside the one the manufacturers intended. Under certain circumstances, patients may benefit from selective application of mix & match. This can refer to primary hip arthroplasty (if evidence suggests that the combination of devices from different manufacturers has superior results) and revision hip or knee arthroplasty (when the exchange of one component only is necessary and the invasiveness of surgery can be reduced). Within the EFORT ‘Implant and Patient Safety Initiative’, evidence- and consensus-based recommendations have been developed for the safe application of off-label use and mix & match in primary as well as revision hip and knee arthroplasty. Prior to the application of a medical device for hip or knee arthroplasty off-label and within a mix & match situation, surgeons should balance the risks and benefits to the patient, obtain informed consent, and document the decision process appropriately. Nevertheless, it is crucial for surgeons to only combine implants that are compatible. Mismatch of components, where their sizes or connections do not fit, may have catastrophic effects and is a surgical mistake. Surgeons must be fully aware of the features of the components that they use in off-label indications or during mix & match applications, must be appropriately trained and must audit their results. Considering the frequent practice of off-label and mix & match as well as the potential medico-legal issues, further research is necessary to obtain more data about the appropriate indications and outcomes for those procedures. Cite this article: EFORT Open Rev 2021;6:982-1005. DOI: 10.1302/2058-5241.6.210080

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Third Place Award Off-label versus on-label outcomes of total joint arthroplasty

Cited by 2 publications

References 12 publications

Prevalence and Perioperative Outcomes of Off-Label Total Hip and Knee Arthroplasty in the United States, 2000–2010

Prevalence and Perioperative Outcomes of Off-Label Total Hip and Knee Arthroplasty in the United States, 2000–2010

EFORT recommendations for off-label use, mix & match and mismatch in hip and knee arthroplasty

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