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Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_6 | Pages 31 - 31
1 May 2019
ANALYSIS OF 3D-PRINTED ACETABULAR COMPONENTS FOR TOTAL HIP ARTHROPLASTY: A COMPARATIVE RETRIEVAL STUDY WITH A CONVENTIONAL DESIGN
Dall'Ava L Hothi H Di Laura A Henckel J Shearing P Hart A
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Introduction

Three-dimensional (3D) printing of porous titanium implants marks a revolution in orthopaedics, promising enhanced bony fixation whilst maintaining design equivalence with conventionally manufactured components. No retrieval study has investigated differences between implants manufactured using these two methods. Our study was the first to compare these two groups using novel non-destructive methods.

Materials and methods

We investigated 16 retrieved acetabular cups divided into ‘3D printed’ (n = 6; Delta TT) and ‘conventional’ (n = 10; Pinnacle Porocoat). The groups were matched for age, time to revision, size and gender (Table 1). Reasons for revision included unexplained pain, aseptic loosening, infection and ARMD. Visual inspection was performed to evaluate tissue attachment. Micro-CT was used to assess clinically relevant morphometric features of the porous structure, such as porosity, depth of the porous layer, pore size and strut thickness. Scanning electron microscopy (SEM) was applied to evaluate the surface morphology.

Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 85 - 85
1 Apr 2019
RETRIEVAL ANALYSIS OF 3D-PRINTED TITANIUM ORTHOPAEDIC IMPLANTS
Dall'Ava L Hothi H Henckel J Cerquiglini A Laura AD Shearing P Hart A
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Introduction

The use of Additive Manufacturing (AM) to 3D print titanium implants is becoming widespread in orthopaedics, particularly in producing cementless porous acetabular components that are either custom-made or off-the-shelf; the primary design rationale for this is enhanced bony fixation by matching the porosity of bone. Analysis of these retrieved components can help us understand their performance; in this study we introduce a non-destructive method of the retrieval analysis of 3D printed implants.

Material and methods

We examined 11 retrieved 3D printed acetabular cups divided into two groups: “custom-made” (n = 4) and “off-the-shelf” (n = 7). A macroscopic visual analysis was initially performed to measure the area of tissue ongrowth. High resolution imaging of each component was captured using a micro-CT scanner and 3D reconstructed models were used to assess clinically relevant morphometric features of the porous structure: porosity, porous structure thickness, pore size and strut thickness. Optical microscopy was also used as a comparison with microCT results. Surface morphology and elemental composition of the implants were investigated with a Scanning Electron Microscope (SEM) coupled with an Energy Dispersive X-ray Spectroscope (EDS). Statistical analysis was performed to evaluate possible differences between the two groups.

Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_12 | Pages 16 - 16
1 Jun 2017
ASSESSMENT OF THE EQUIVALENCE OF A GENERIC TO A BRANDED FEMORAL STEM
Hothi H Henckel J Shearing P Atrey A Skinner J Hart A
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Several implants have a proven track record of durability and function in patients over many years. As manufacturers' patents expire it is understandable that cheaper generic copies would be considered. There is currently no established, independent method of determining design equivalence between generic and branded orthopaedic implants.

We acquired 10 boxed, as manufactured components consisting of the generic OptiStem XTR model (n=5) and branded Exeter (n=5) femoral stems. Two examiners were blinded to the implant design and independently measured the mass, volume, trunnion surface topography, roughness, trunnion cone angle, CCD angle and femoral offset using peer-reviewed methods. We then compared the stems using these parameters.

We found that the OptiStems (1) were lighter (p<0.001) (2) had a rougher trunnion surface (p<0.001) with a greater spacing and depth of the machined threads (p<0.001), (3) had greater trunnion cone angles (p=0.007) and (4) a smaller radius at the top of the trunnion (p=0.007). There was no difference for stem volume (p=0.643), CCD angle (p=0.788) or offset (p=0.993).

This study is the first independent investigation of the equivalence of a generic orthopaedic implant to its branded design. We found a clear difference in trunnion roughness, trunnion cone angle and radius, and implant mass when comparing the two generic and branded stem designs. All implants require standard regulatory processes to be followed. It does not appear feasible that generic implants can be manufactured to predictability guarantee the same performance as generic drugs.

We found a number of physical differences between the generic and branded implants. Whilst both designs are likely to work in clinical practice, they are different.

The Bone & Joint Journal
Vol. 99-B, Issue 3 | Pages 310 - 316
1 Mar 2017
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 Skinner J Hart A
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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.