Premature Consolidation with Resultant Implant Failure Using PRECICE Femoral Nail Lengthening

Morrison, Todd A.; Sontich, John K.

doi:10.2106/jbjs.cc.o.00059

Cited by 11 publications

(7 citation statements)

References 16 publications

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“…Though these studies demonstrate preservation of treatment successes with relative elimination of external fixation related complications, inadvertent consequences undoubtedly arise. The earlier intramedullary lengthening devices were associated with mechanical failures, including intra-operative disassembly, failure to activate the device, and breakage of the device [ 10 , 26 ]. A more recent iteration of a lengthening device made of stainless steel has drawn recent negative attention given its reports of adverse tissue reaction surround its modular junction.…”

Section: Discussionmentioning

confidence: 99%

“…These devices have successfully addressed many of the limitations of external fixation, though other inadvertent complications have arisen. A titanium magnetic intramedullary construct (PRECICE, Nuvasive, San Diego, CA, USA) was introduced in 2011, but intra-operative disassembly at the modular junction and limited weight bearing resulted in hesitancy with its adoption [ 10 ]. The latest stainless-steel iteration (PRECICE, STRYDE Nail System, Nuvasive) approved in 2018 offered theoretical advantages of early weight bearing and earlier consolidation.…”

Section: Introductionmentioning

confidence: 99%

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

Sax¹,

Hlukha²,

Kowalewski³

et al. 2022

Children

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Concerns surrounding osteolysis near and around the modular junction of a stainless-steel intramedullary lengthening rod prompted a manufacturer recall from the 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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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Sax¹,

Hlukha²,

Kowalewski³

et al. 2022

Children

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“…Since gaining United States Food and Drug Administration approval for lengthening of the femur and tibia in 2011, failures have been reported resulting in modification in the design of the nail. 16 , 17 The initial modular implant is now manufactured as a monobloc nail due to breakages occurring between the initial connecting segment welds and the internal mechanisms have been changed to produce a stronger, more robust device with an increase in the size of the actuator driving pin. The derotation ‘crown’ following breakage has also been removed in the latest design.…”

Section: Introductionmentioning

confidence: 99%

A retrieval analysis of the Precice intramedullary limb lengthening system

Panagiotopoulou

Davda

Hothi

et al. 2018

Bone & Joint Research

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ObjectivesThe Precice nail is the latest intramedullary lengthening nail with excellent early outcomes. Implant complications have led to modification of the nail design. The aim of this study was to perform a retrieval study of Precice nails following lower-limb lengthening and to assess macroscopical and microscopical changes to the implants and evaluate differences following design modification, with the aim of identifying potential surgical, implant, and patient risk factors.MethodsA total of 15 nails were retrieved from 13 patients following lower-limb lengthening. Macroscopical and microscopical surface damage to the nails were identified. Further analysis included radiology and micro-CT prior to sectioning. The internal mechanism was then analyzed with scanning electron microscopy and energy dispersive x-ray spectroscopy to identify corrosion.ResultsSeven male and three female patients underwent 12 femoral lengthenings. Three female patients underwent tibial lengthening. All patients obtained the desired length with no implant failure. Surface degradation was noted on the telescopic part of every nail design, less on the latest implants. Microscopical analysis confirmed fretting and pitting corrosion. Following sectioning, black debris was noted in all implants. The early designs were found to have fractured actuator pins and the pin and bearings showed evidence of corrosive debris. The latest designs showed evidence of biological deposits suggestive of fluid ingress within the nail but no corrosion.ConclusionThis study confirms less internal corrosion following modification, but evidence of titanium debris remains. We recommend no change to current clinical practice. However, potential reuse of the Precice nail, for secondary limb lengthening in the same patient, should be undertaken with caution.Cite this article: V. C. Panagiotopoulou, K. Davda, H. S. Hothi, J. Henckel, A. Cerquiglini, W. D. Goodier, J. Skinner, A. Hart, P. R. Calder. A retrieval analysis of the Precice intramedullary limb lengthening system. Bone Joint Res 2018;7:476–484. DOI: 10.1302/2046-3758.77.BJR-2017-0359.R1.

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“…Además, permite su introducción en el fémur de manera anterógrada (a través del trocánter mayor o vía piriforme) o retrógrada; y anterógrada en el caso de la tibia. 11,14 Diferentes estudios concluyen en la utilización en adolescentes de la vía anterógrada a través del trocánter mayor, ya que presenta menor tasa de necrosis avascular de la cabeza femoral. 13,15,16 El clavo de segunda generación aporta modelos para el fémur con diámetros de 8.5, 10.7 y 12.5 mm, con longitudes entre 195 y 365 mm y con patrones de orificios para los tornillos distales en dos planos diferentes que permiten la adaptación a la variedad anatómica de los pacientes.…”

Section: Discussionunclassified

Primera serie de casos de alargamiento femoral mediante clavo intramedular Precice® en nuestro centro

Marquina¹,

Novoa²,

Badía³

et al. 2022

Acta Ortopédica Mexicana

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Premature Consolidation with Resultant Implant Failure Using PRECICE Femoral Nail Lengthening

Cited by 11 publications

References 16 publications

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

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

A retrieval analysis of the Precice intramedullary limb lengthening system

Primera serie de casos de alargamiento femoral mediante clavo intramedular Precice® en nuestro centro

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