Comparative analysis of conventionally and additively manufactured acetabular shells from a single manufacturer.

BACKGROUND: The Trident II Tritanium acetabular shell is additively manufactured (3D printed), based on the established Trident 'I' Tritanium shell, produced using conventional methods; this study characterised their differences. METHODS: We obtained 5 Trident I (T1) and 5 Trident II (T2) shells sized 52 mm, 54 mm (n = 3) and 60 mm. We measured their: mass, shell-liner engaging surface roughness, roundness, wall thickness, the depth of the bone-facing porous layer, porosity, and the number, volume and location of structural voids. RESULTS: The mass varied by up to 13.44 g. The T1 and T2 shells had a median internal roughness of 0.18 µm and 0.43 µm, (p < 0.001) and the median departure from roundness was 6.9 µm and 8.9 µm, (p < 0.001). The 54 mm and 60 mm T2 shell walls were 37% and 29% thinner than their T1 counterparts (p < 0.01). The T2 shells had irregular porous structures, shallower in depth by 11-27% (p < 0.001) than T1 shells, which had repeating mesh units; the overall porosity was comparable (54%). All T2 shells had between 115 and 3415 structural voids, compared with two T1 shells containing 21 and 31 voids. There was no difference in the depth of the porous layer for the 54 mm T2 shells (p = 0.068), whilst T1 shells did show variability (p < 0.01). Both groups showed a variability in surface roughness and roundness (p < 0.01). CONCLUSION: This is the first study to compare shells from a single manufacturer, produced using conventional and additive methods. This data will help interpret the performance of the 3D printed Trident II as longer-term clinical data is generated.

Characterisation of 3D-printed acetabular hip implants.

Three-dimensional printing is a rapidly growing manufacturing method for orthopaedic implants and it is currently thriving in several other engineering industries. It enables the variation of implant design and the construction of complex structures which can be exploited in orthopaedics and other medical sectors. In this review, we develop the vocabulary to characterise 3D printing in orthopaedics from terms defined by industries employing 3D printing, and by fully examining a 3D-printed off-the-shelf acetabular cup (Fig. 1). This is a commonly used 3D-printed implant in orthopaedics, and it exhibits a range of prominent features brought about by 3D printing. The key features and defects of the porous and dense regions of the implant are clarified and discussed in depth to determine reliable definitions and a common understanding of characteristics of 3D printing between engineers and medical experts in orthopaedics. Despite the extensive list of terminology derived here, it is clear significant gaps exist in the knowledge of this field. Therefore, it is necessary for continued investigations of unused implants, but perhaps more significantly, examining those in vivo and retrieved to understand their long-term impact on patients and the effects of certain features (e.g. surface-adhered particles). Analyses of this kind will establish an understanding of 3D printing in orthopaedics and additionally it will help to update the regulatory approach to this new technology.

Surface adhered titanium particles on 3D printed off-the-shelf acetabular cups.

3D printing is a rapidly growing manufacturing method of medical implants. In orthopedics, this method enables the construction of complex porous structures with the aim of improved bone fixation. A known by-product of the 3D printing process is surface adhered particles which are often challenging to remove from the strut surfaces of the porous region. This study investigates the presence of these particles in the porous region of unused 3D printed off-the-shelf acetabular cup from five manufacturers. Scanning Electron Microscopy (SEM) and image analysis software were used to determine the frequency and diameters of particles present on these implants. Surface adhered particles were found in the porous structures of all implants with some exhibiting more particles at the subsurface level than the surface level. Implants manufactured via Selective Laser Melting (SLM) exhibited a higher number of surface adhered particles per mm2 at both the surface and subsurface levels than those manufactured by Electron Beam Melting (EBM). Additionally, and consistent with previous literature, the particle diameter of the SLM cups was found to be smaller than those on the EBM cups, as well as having a visually lower level of adherence which could raise concern about the likelihood of breakage of these particles in-vivo.

The analysis of defects in custom 3D-printed acetabular cups: A comparative study of commercially available implants from six manufacturers.

Three-dimensional (3D) printing is used to manufacture custom acetabular cups to treat patients with massive acetabular defects. There is a risk of defects occurring in these, often in the form of structural voids. Our aim was to investigate the presence of voids in commercially available cups. We examined 12, final-production titanium custom acetabular cups, that had been 3D-printed by six manufacturers. We measured their mass, then performed micro-computed tomography (micro-CT) imaging to determine their volume and density. The micro-CT data were examined for the presence of voids. In cups that had voids, we computed (1) the number of voids, (2) their volume and the cup volume fraction, (3) their sphericity, (4) size, and (5) their location. The cups had median mass, volume, and density of 208.5 g, 46,471 mm3 , and 4.42 g/cm3 , respectively. Five cups were found to contain a median (range) of 90 (58-101) structural voids. The median void volume and cup volume fractions of cups with voids were 5.17 (1.05-17.33) mm3 and 99.983 (99.972-99.998)%, respectively. The median void sphericity and size were 0.47 (0.19-0.65) and 0.64 (0.27-8.82) mm, respectively. Voids were predominantly located adjacent to screw holes, within flanges, and at the transition between design features; these were between 0.17 and 4.66 mm from the cup surfaces. This is the first study to examine defects within final-production 3D-printed custom cups, providing data for regulators, surgeons, and manufacturers about the variability in final print quality. The size, shape, and location of these voids are such that there may be an increased risk of crack initiation from them.

Morphometric analysis of patient-specific 3D-printed acetabular cups: a comparative study of commercially available implants from 6 manufacturers.

BACKGROUND: 3D printed patient-specific titanium acetabular cups are used to treat patients with massive acetabular defects. These have highly porous surfaces, with the design intent of enhancing bony fixation. Our aim was to characterise these porous structures in commercially available designs. METHODS: We obtained 12 final-production, patient-specific 3D printed acetabular cups that had been produced by 6 manufacturers. High resolution micro-CT imaging was used to characterise morphometric features of their porous structures: (1) strut thickness, 2) the depth of the porous layer, (3) pore size and (4) the level of porosity. Additionally, we computed the surface area of each component to quantify how much titanium may be in contact with patient tissue. Statistical comparisons were made between the designs. RESULTS: We found a variability between designs in relation to the thickness of the struts (0.28 to 0.65 mm), how deep the porous layers are (0.57 to 11.51 mm), the pore size (0.74 to 1.87 mm) and the level of porosity (34 to 85%). One manufacturer printed structures with different porosities between the body and flange; another manufacturer had two differing porous regions within the body of the cups. The cups had a median (range) surface area of 756.5 mm2 (348 - 1724). CONCLUSIONS: There is a wide variability between manufacturers in the porous titanium structures they 3D print. We do not currently know whether there is an optimal porosity and how this variability will impact clinically on the integrity of bony fixation; this will become clearer as post market surveillance data is generated.

Augmented-Reality-Assisted K-Wire Placement for Glenoid Component Positioning in Reversed Shoulder Arthroplasty: A Proof-of-Concept Study.

The accuracy of the implant's post-operative position and orientation in reverse shoulder arthroplasty is known to play a significant role in both clinical and functional outcomes. Whilst technologies such as navigation and robotics have demonstrated superior radiological outcomes in many fields of surgery, the impact of augmented reality (AR) assistance in the operating room is still unknown. Malposition of the glenoid component in shoulder arthroplasty is known to result in implant failure and early revision surgery. The use of AR has many promising advantages, including allowing the detailed study of patient-specific anatomy without the need for invasive procedures such as arthroscopy to interrogate the joint's articular surface. In addition, this technology has the potential to assist surgeons intraoperatively in aiding the guidance of surgical tools. It offers the prospect of increased component placement accuracy, reduced surgical procedure time, and improved radiological and functional outcomes, without recourse to the use of large navigation or robotic instruments, with their associated high overhead costs. This feasibility study describes the surgical workflow from a standardised CT protocol, via 3D reconstruction, 3D planning, and use of a commercial AR headset, to AR-assisted k-wire placement. Post-operative outcome was measured using a high-resolution laser scanner on the patient-specific 3D printed bone. In this proof-of-concept study, the discrepancy between the planned and the achieved glenoid entry point and guide-wire orientation was approximately 3 mm with a mean angulation error of 5°.

Ten year survivorship after cemented and uncemented medial Uniglide® unicompartmental knee arthroplasties.

BACKGROUND: Results of knee replacement registries have shown that unicompartmental knee arthroplasty (UKA) has a significantly higher revision and failure rate than current state-of-the-art TKA. The aim of this prospective study is to evaluate the long-term outcomes and to calculate the 10 year survival of knees with medial osteoarthritis treated with Uniglide® UKA. METHODS: Two hundred thirty-four patients were assessed by an independent clinical observer using the American Knee Society Clinical Rating System, a validated outcome measure. Kaplan-Meier analysis was used to calculate the 10 year survival rates using revision surgery for any cause as the end point. RESULTS: There were no revisions due to progression of lateral osteoarthritis or polyethylene failure. There were one traumatic and three non-traumatic bearing dislocations and two revisions due to aseptic loosening of the tibial component. One joint was revised for traumatic ligament rupture, one for synovitis from bearing impingement, one due to femoral component mal-positioning and one for infection. A total of 10 cases were revised due to failures for any cause in the 61 patients withdrawn because they had died, thus giving a cumulative survival rate at 10 years of 95.57%. The knee (function) score showed an increase from 33.4 (54.7) pre-operatively to 94 (83.4) points post-operatively. The average range of motion increased from 107 to 122° (p<0.01). CONCLUSION: Based on our findings we believe that the Uniglide® unicompartmental knee prosthesis offers a safe and effective solution for the treatment of medial compartment osteoarthritis.

Large ball metal on metal hips obscure cup angle measurement on plain radiographs.

CT when compared to plain radiograph is known to be a more valid measure of acetabular component orientation. The validity of plain radiographs may be further compromised by large diameter metal femoral heads because of obscuration of the acetabular rim. We quantified this effect by measuring acetabular cup angles (inclination and version) of 49 metal on metal (MOM) hip resurfacings using plain radiographs and 3D CT based measurement. Bland-Altman plots revealed poor agreement between plain radiographic and CT based measurement with 2 standard deviation limits of agreements of: +7 to -15 degrees for cup inclination angle; and +16 to -31 degrees for cup version angle. The large differences between plain radiographic and CT measurement of cup positions are probably due to the large diameter metal femoral head that can obscure the cup margin. We have used a metal artefact reduction CT protocol with a 3D imaging software package to overcome this problem and measure cup position relative to the Anterior Pelvic Plane.