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Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?

Concerns surrounding osteolysis near and around the modular junction of a stainless-steel intramedullary lengthening rod prompted a manufacturer recall from the United States market in early 2021. These actions were preceded by similar steps taken in Europe. A concomitant review of stainless-steel l...

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Autores principales: Sax, Oliver C., Hlukha, Larysa P., Kowalewski, Kyle A., Herzenberg, John E., McClure, Philip K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9221827/
https://www.ncbi.nlm.nih.gov/pubmed/35740797
http://dx.doi.org/10.3390/children9060860
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author Sax, Oliver C.
Hlukha, Larysa P.
Kowalewski, Kyle A.
Herzenberg, John E.
McClure, Philip K.
author_facet Sax, Oliver C.
Hlukha, Larysa P.
Kowalewski, Kyle A.
Herzenberg, John E.
McClure, Philip K.
author_sort Sax, Oliver C.
collection PubMed
description Concerns surrounding osteolysis near and around the modular junction of a stainless-steel intramedullary lengthening rod prompted a manufacturer recall from the United States market in early 2021. These actions were preceded by similar steps taken in Europe. A concomitant review of stainless-steel lengthenings at our institution demonstrated signs of adverse tissue reaction including periosteal reaction and osteolysis at the modular junction and/or male-sided locking screws. Nearly half of our patients presented with these findings on radiographic images. At the time of the previous review, only half of the nearly 60 implanted stainless-steel devices met a 6-month follow-up. At this juncture, many patients have had their devices explanted. Given the suspected adverse tissue reactions caused by a component of the internal device, we sought to examine the rate of osteolysis post-explantation following removal of a stainless-steel nail. We reviewed a consecutive series of patients who underwent implantation of a stainless-steel limb lengthening device in the femur and/or tibia at a single institution between December 2018 and December 2020. Patients were included if their device was explanted. Periosteal reaction and osteolysis was classified according to a novel and validated classification system, as analyzed by five fellowship-trained surgeons. In addition, changes observed prior to explantation were tracked post-explantation to assess for resolution. The incidence of periosteal reaction and osteolysis prior to explantation was 22/57 (39%) and 15/57 (26%), respectively. Of the 15 patients with osteolysis pre-explantation, 14 patients’ implants were explanted. Of these, eight patients had available follow-up films. Two patients were identified as having partial osteolysis resolution at mean 1-year follow-up, while six patients were identified as having complete osteolysis at mean 18-months follow-up. Periosteal tissue reaction and osteolysis largely resolved following explantation in a subset of patients. These results provide further support to the claim that the stainless-steel device contributed to the changes seen. Further follow-up is warranted to examine the longer-term effects of adverse tissue reaction in this patient population.
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spelling pubmed-92218272022-06-24 Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation? Sax, Oliver C. Hlukha, Larysa P. Kowalewski, Kyle A. Herzenberg, John E. McClure, Philip K. Children (Basel) Article Concerns surrounding osteolysis near and around the modular junction of a stainless-steel intramedullary lengthening rod prompted a manufacturer recall from the United States market in early 2021. These actions were preceded by similar steps taken in Europe. A concomitant review of stainless-steel lengthenings at our institution demonstrated signs of adverse tissue reaction including periosteal reaction and osteolysis at the modular junction and/or male-sided locking screws. Nearly half of our patients presented with these findings on radiographic images. At the time of the previous review, only half of the nearly 60 implanted stainless-steel devices met a 6-month follow-up. At this juncture, many patients have had their devices explanted. Given the suspected adverse tissue reactions caused by a component of the internal device, we sought to examine the rate of osteolysis post-explantation following removal of a stainless-steel nail. We reviewed a consecutive series of patients who underwent implantation of a stainless-steel limb lengthening device in the femur and/or tibia at a single institution between December 2018 and December 2020. Patients were included if their device was explanted. Periosteal reaction and osteolysis was classified according to a novel and validated classification system, as analyzed by five fellowship-trained surgeons. In addition, changes observed prior to explantation were tracked post-explantation to assess for resolution. The incidence of periosteal reaction and osteolysis prior to explantation was 22/57 (39%) and 15/57 (26%), respectively. Of the 15 patients with osteolysis pre-explantation, 14 patients’ implants were explanted. Of these, eight patients had available follow-up films. Two patients were identified as having partial osteolysis resolution at mean 1-year follow-up, while six patients were identified as having complete osteolysis at mean 18-months follow-up. Periosteal tissue reaction and osteolysis largely resolved following explantation in a subset of patients. These results provide further support to the claim that the stainless-steel device contributed to the changes seen. Further follow-up is warranted to examine the longer-term effects of adverse tissue reaction in this patient population. MDPI 2022-06-09 /pmc/articles/PMC9221827/ /pubmed/35740797 http://dx.doi.org/10.3390/children9060860 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sax, Oliver C.
Hlukha, Larysa P.
Kowalewski, Kyle A.
Herzenberg, John E.
McClure, Philip K.
Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?
title Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?
title_full Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?
title_fullStr Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?
title_full_unstemmed Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?
title_short Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?
title_sort does focal osteolysis in a precice stryde intramedullary lengthening nail resolve after explantation?
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9221827/
https://www.ncbi.nlm.nih.gov/pubmed/35740797
http://dx.doi.org/10.3390/children9060860
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