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Assessment of the equivalence of a generic to a branded femoral stem.

Hothi, H; Henckel, J; Shearing, P; Holme, T; Cerquiglini, A; Laura, AD; Atrey, A; ... Hart, A; + view all (2017) Assessment of the equivalence of a generic to a branded femoral stem. Bone Joint J , 99-B (3) pp. 310-316. 10.1302/0301-620X.99B3.BJJ-2016-1208.R1. Green open access

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Abstract

AIMS: The aim of this study was to compare the design of the generic OptiStem XTR femoral stem with the established Exeter femoral stem. MATERIALS AND METHODS: We obtained five boxed, as manufactured, implants of both designs at random (ten in total). Two examiners were blinded to the implant design and independently measured the mass, volume, trunnion surface topography, trunnion roughness, trunnion cone angle, Caput-Collum-Diaphyseal (CCD) angle, femoral offset, stem length, neck length, and the width and roughness of the polished stem shaft using peer-reviewed methods. We then compared the stems using these parameters. RESULTS: We found that the OptiStems were lighter (p < 0.001), had a rougher trunnion surface (p < 0.001) with a greater spacing and depth of the machined threads (p < 0.001), had greater trunnion cone angles (p = 0.007), and a smaller radius at the top of the trunnion (p = 0.007). There was no difference in stem volume (p = 0.643), CCD angle (p = 0.788), offset (p = 0.993), neck length (p = 0.344), stem length (p = 0.808), shaft width (p = 0.058 to 0.720) or roughness of the polished surface (p = 0.536). CONCLUSION: This preliminary investigation found that whilst there were similarities between the two designs, the generic OptiStem is different to the branded Exeter design. Cite this article: Bone Joint J 2017;99-B:310-16.

Type: Article
Title: Assessment of the equivalence of a generic to a branded femoral stem.
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1302/0301-620X.99B3.BJJ-2016-1208.R1
Publisher version: http://dx.doi.org/10.1302/0301-620X.99B3.BJJ-2016-...
Language: English
Additional information: © 2017 Hothi et al. This is an open-access article distributed under the terms of the Creative Commons Attributions licence (CC-BY-NC), which permits unrestricted use, distribution, and reproduction in any medium, but not for commercial gain, provided the original author and source are credited.
Keywords: Branded, Equivalence, Generic, Hip, Stem
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci > Department of Ortho and MSK Science
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Chemical Engineering
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Mechanical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/1543987
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