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Analysis of retrieved STRYDE nails.

Harry Hothi¹, Sean Bergiers¹, Johann Henckel¹

¹The Royal National Orthopaedic Hospital, London, UK.

Bone & Joint Open

|August 5, 2021

Summary

Retrieval analysis of PRECICE STRYDE nails revealed corrosion at the extendable junctions, associated with bone changes like osteolysis. Further research is needed to understand these findings in implant surveillance.

Keywords:

Energy dispersive x-ray spectroscopy Limb lengthening PRECICE lengthening nail Plain radiographs Retrieval analysis STRYDE nail blood metal ion chromium femoral nails infection osteolysis radiographs tibial bones tibial nails

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Area of Science:

Orthopedic surgery
Biomaterials science
Medical device analysis

Background:

PRECICE STRYDE intramedullary nails are recently introduced devices for bone lengthening.
Post-market surveillance is crucial for evaluating the long-term performance and safety of orthopedic implants.

Purpose of the Study:

To conduct the first retrieval analysis of PRECICE STRYDE intramedullary nails.
To investigate the presence and characteristics of corrosion and associated bone reactions in retrieved implants.

Main Methods:

Ten PRECICE STRYDE nails were retrieved from six patients after successful treatment.
Macro- and microscopic analyses, energy dispersive X-ray spectroscopy (EDS), and metrology were performed.
Corrosion was graded using validated semiquantitative scoring methods.

Main Results:

All retrieved nails showed evidence of corrosion, primarily at screw holes and extendable junctions.
Five of ten nails exhibited moderate to severe junctional corrosion.
EDS analysis indicated chromium-rich surface deposits.
Radiographs revealed cortical thickening and osteolysis adjacent to the junctions in six nails.

Conclusions:

Corrosion at the extendable junction of PRECICE STRYDE nails is associated with adjacent cortical thickening and osteolysis in united bone.
Further investigation with larger sample sizes is necessary to fully elucidate the relationship between corrosion and bony changes.
Understanding surgeon, implant, and patient factors influencing these outcomes is essential.