Analysis of retrieved STRYDE nails

Abstract

Aims The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices. Methods We collected ten nails removed from six patients, together with patient clinical data and plain radiograph imaging. We performed macro- and microscopic analysis of all surfaces and graded the presence of corrosion using validated semiquantitative scoring methods. We determined the elemental composition of surface debris using energy dispersive x-ray spectroscopy (EDS) and used metrology analysis to characterize the surface adjacent to the extendable junctions. Results All nails were removed at the end of treatment, having achieved their intended lengthening (20 mm to 65 mm) and after regenerate consolidation. All nails had evidence of corrosion localized to the screw holes and the extendable junctions; corrosion was graded as moderate at the junction of one nail and severe at the junctions of five nails. EDS analysis showed surface deposits to be chromium rich. Plain radiographs showed cortical thickening and osteolysis around the junction of six nails, corresponding to the same nails with moderate – severe junction corrosion. Conclusion We found, in fully united bones, evidence of cortical thickening and osteolysis that appeared to be associated with corrosion at the extendable junction; when corrosion was present, cortical thickening was adjacent to this junction. Further work, with greater numbers of retrievals, is required to fully understand this association between corrosion and bony changes, and the influencing surgeon, implant, and patient factors involved. Cite this article: Bone Jt Open 2021;2(8):599–610.

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

“…A similar report by Frommer et al [ 20 ] identified osteolytic changes in 20 of the 57 (35%) implanted nails at a mean 9.5 months after index lengthening surgery. They also found macroscopic corrosion at the modular junction in 83% of recipients, similar to that reported by our group in a previous publication [ 19 ] and a separate analysis of retrieved nails at another institution [ 30 ]. In a comparative study of multiple variations of an intramedullary limb lengthening nail, Iobst et al [ 29 ] observed a greater proportion of bone abnormalities at the modular junction of the STRYDE nail, as compared to the PRECICE or FITBONE (Orthofix Medical Inc., Lewisville, TX, USA).…”

“…Since a manufacturer recall in early 2021, multiple reports have demonstrated the presence of adverse tissue reactions in stainless-steel intramedullary lengthening nails [ 19 , 20 , 21 , 22 , 23 , 24 , 29 , 30 ]. In a report of three cases, Sax et al [ 19 ] demonstrated radiographic osteolysis in patients implanted with the stainless-steel nail with histologic confirmation of phagocytic activity of green-gold crystalline debris characteristic of metal debris.…”

A clinical and radiological matched-pair analysis of patients treated with the PRECICE and STRYDE magnetically driven motorized intramedullary lengthening nails

“…This reflects the observations of Iobst et al 15 who believed the finding to be STRYDE-specific, and one could speculate that mechanically assisted corrosion at the bolts weakened the material and made them more susceptible to breakage under full load. 8,9,12,15 There was no relevant difference in terms of distraction and consolidation indices between the STRYDE and PRECICE cohort, in contrast to the results of Galal et al, 14 who reported a statistically significant lower distraction rate and a statistically significant higher bone healing index for their STRYDE compared to their PRECICE cohort. However, bone healing seemed to be affected in patients treated with the STRYDE nail in our cohort, since these patients were more likely to undergo revision surgery due to delayed consolidation in comparison to the PRECICE cohort.…”

“…However, they are limited in terms of comparability to other intramedullary lengthening systems. [8][9][10][11][12][13]15,21 This study was designed to provide a comprehensive approach in terms of clinical and radiological outcome of treatment with the conventional PRECICE and the STRYDE intramedullary lengthening nail. Compared to previous studies, a large and homogenous group of patients using a 2:1 matched-pair design was examined.…”

Technical considerations and early results of magnetic compressive intramedullary nailing for humeral shaft delayed unions and nonunions

“…Fretting corrosion, or micromotion at the same site, as well as pitting corrosion have also been implicated. 7 , 12 , 15 , 18 However, further investigation regarding the incidence, consequence, and correction of this sequelae is needed.…”