3D printing acetabular cups offers the theoretical advantage of enhanced bony fixation due to greater design control of the porous implant surfaces. Analysing retrieved 3D printed implants can help determine whether this design intent has been achieved.

We sectioned 14 off-the-shelf retrieved acetabular cups for histological analysis; 7 cups had been 3D printed and 7 had been conventionally manufactured. Some of the most commonly used contemporary designs were represented in both groups, which were removed due to either aseptic loosening, unexplained pain, infection or dislocation. Clinical data was collected for all implants, including their age, gender, and time to revision.

Bone ingrowth was evaluated using microscopic assessment and two primary outcome measures: 1) bone area fraction and 2) extent of bone ingrowth.

The additively manufactured cups were revised after a median (IQR) time of 24.9 months (20.5 to 45.6) from patients with a median (IQR) age of 61.1 years (48.4 to 71.9), while the conventional cups had a median (IQR) time to revision of 46.3 months (34.7 to 49.1, p = 0.366) and had been retrieved from patients with a median age of 66.0 years (56.9 to 68.9, p = 0.999).

The additively and conventionally manufactured implants had a median (IQR) bone area fraction of 65.7% (36.4 to 90.6) and 33.9% (21.9 to 50.0), respectively (p < 0.001).

A significantly greater amount of bone ingrowth was measured into the backside of the additively manufactured acetabular cups, compared to their conventional counterparts (p < 0.001). Bone occupied a median of 60.0% and 5.7% of the porous depth in the additively manufactured and conventional cups, respectively.

3D printed components were found to achieve a greater amount of bone ingrowth than their conventionally manufactured counterparts, suggesting that the complex porous structures generated through this manufacturing technique may encourage greater osteointegration.

3D printing is rapidly being adopted by manufacturers to produce orthopaedic implants. There is a risk however of structural defects which may impact mechanical integrity. There are also no established standards to guide the design of bone-facing porous structures, meaning that manufacturers may employ different approaches to this. Characterisation of these variables in final-production implants will help understanding of the impact of these on their clinical performance.

We analysed 12 unused, final-production custom-made 3D printed acetabular cups that had been produced by 6 orthopaedic manufacturers. We performed high resolution micro-CT imaging of each cup to characterise the morphometric features of the porous layers: (1) the level of porosity, (2) pore size, (3) thickness of porous struts and (4) the depth of the porous layers. We then examined the internal cup structures to identify the presence of any defects and to characterise: (1) their total number, (2) volume, (3) sphericity, (4) size and (5) location.

There was a variability between designs in the level of porosity (34% to 85%), pore size (0.74 to 1.87mm), strut thickness (0.28 to 0.65mm), and porous layer depth (0.57 to 11.51mm). One manufacturer printed different porous structures between the cup body and flanges; another manufacturer printed two differing porous regions within the cup body.

5 cups contained a median (range) of 90 (58–101) defects. The median defect volume was 5.17 (1.05–17.33) mm3. The median defect sphericity and size were 0.47 (0.19–0.65) and 0.64 (0.27–8.82) mm respectively. The defects were predominantly located adjacent to screw holes, within flanges and at the transition between the flange and main cup body; these were between 0.17 and 4.66mm from the cup surfaces.

There is a wide variability between manufacturers in the porous titanium structures they 3D print. The size, shape and location of the structural defects identified are such that there may be an increased risk of crack initiation from them, potentially leading to a fracture. Regulators, surgeons, and manufacturers should be aware of this variability in final print quality.

Abstract

MAGnetic Expansion Control (MAGEC) rods are used in the surgical treatment of children with early onset scoliosis. The magnetically controlled lengthening mechanism enables rod distractions without the need for repeated invasive surgery. The CE certification of these devices was suspended in March 2021 due, primarily, to performance evidence gaps in the documents provided by the manufacturer to regulators and notified bodies. MAGEC rods are therefore not permitted for use in countries requiring CE marking. This was a survey of 18 MAGEC rod surgeons in the UK about their perception of the impact of the CE suspension on the clinical management of their patients. Unsurprisingly, virtually all perceived a negative impact, reflecting the complexity of this patient group. Reassuringly, these surgeons are highly experienced in alternative treatment methods.

Cite this article: Bone Jt Open 2022;3(2):155–157.

Aims

Acetabular edge-loading was a cause of increased wear rates in metal-on-metal hip arthroplasties, ultimately contributing to their failure. Although such wear patterns have been regularly reported in retrieval analyses, this study aimed to determine their in vivo location and investigate their relationship with acetabular component positioning.

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.

Aims

The main advantage of 3D-printed, off-the-shelf acetabular implants is the potential to promote enhanced bony fixation due to their controllable porous structure. In this study we investigated the extent of osseointegration in retrieved 3D-printed acetabular implants.

Aims

The optimum clearance between the bearing surfaces of hip arthroplasties is unknown. Theoretically, to minimize wear, it is understood that clearances must be low enough to maintain optimal contact pressure and fluid film lubrication, while being large enough to allow lubricant recovery and reduce contact patch size. This study aimed to identify the relationship between diametrical clearance and volumetric wear, through the analysis of retrieved components.

Introduction

The achieved anteversion of uncemented stems is to a large extent limited by the internal anatomy of the bone. A better understanding of this has recently become an unmet need because of the increased use of uncemented stems.

We aimed to assess plan compliance in six degrees of freedom to evaluate the accuracy of PSI and guides for stem positioning in primary THAs.

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.

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.

Objectives

The Attune total knee arthroplasty (TKA) has been used in over 600 000 patients worldwide. Registry data show good clinical outcome; however, concerns over the cement-tibial interface have been reported. We used retrieval analysis to give further insight into this controversial topic.

Introduction

Modular-neck hips have twice the rate of revision compared to fixed stems. Metal related pathology is the second most common reason for revision of implants featuring titanium stems with cobalt chrome necks. We aimed to understand the in-vivo performance of current designs and explore the rationale for their continued use.

Introduction

Numerous studies have reported on clinically significant volumes of material loss and corrosion at the head-stem junction of metal-on-metal (MOM) hips; less is understood about metal-on-polyethylene (MOP) hips. We compared the effect of bearing type (MOM vs MOP) on taper material loss for a hip system of a single design (DePuy Pinnacle).

Dual mobility (DM) cups are designed to improve stability, however have been associated with increased risk of impingement that can ultimately result in intraprosthetic dislocation. It is speculated that the femoral neck plays a role in their performance. We investigated the effect of neck topography on the wear of new-generation liners.

This was a retrieval study involving 70 DM cups implanted with liners made of highly crosslinked polyethylene and paired with two neck types: either highly polished (n=35) or rough necks (n=35). The median time of implantation was 30 months.

The rim edge of all inserts was investigated by two examiners for evidence of contact with the femoral neck, presenting as deformation of the polyethylene. A high precision roundness machine and micro-CT scans of the components were used to measure the size of the deformations observed.

28 of the 35 (80%) DM liners paired with rougher necks had evidence of neck impingement resulting in a raised lip, whilst 8 out of 35 (23%) liners paired with smooth necks had a raised lip; this difference was significant (p<0.0001). The repeatability and the inter-observer reproducibility of the deformation scores was found to be substantial κ >0.70. The height of the raised rims of the DM cups paired with rough necks had a median (range) of 139 µm (72–255), whilst had a median (range) of 52 µm (45–90) with smooth necks, the difference between the groups was significant (p<0.0001).

Liner rim deformation resulting from contact with the femoral neck likely begins during early in-vivo function.

Rough necks can increase the damage on the polyethylene rim in dual-mobility bearing, which may lead to loss of the retentive power of these components over time.

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.

Introduction

The Precice nail is the latest intramedullary lengthening nail with excellent early outcomes. Implant complications have led to modification of the nail design. The aim of this study was to perform a retrieval study of Precice nails following lower limb lengthening. To assess macroscopic and microscopic changes to the implants and assess differences following design modification, with identification of potential surgical, implant and patient risk factors.

Dual-taper implants provide surgeons with options to optimise patients' anatomy intraoperatively but are at risk of early revision due to adverse tissue reactions to corrosion debris. Risk factors for failure and linkage with symptoms however are not fully understood. We related retrieval findings to clinical and implant variables.

This study involved 88 failed dual-taper implants with TMZF femoral stems and cobalt-chromium necks, revised for pain, elevated Co (median = 7.3μg/L) and Cr (median = 2.15μg/L) ions levels and fluid collection on MRI.

Stem-neck surfaces were assessed for: 1) severity of corrosion using a published visual method and 2) severity of material lost and location of damage with a roundness-measuring machine. Five traces were taken on each round section of the taper surface at 45° increments to compute the relative depth of damage. The total area of these traces provided a measure of surface damage for comparative purposes.

The stem-neck taper junctions were severely corroded; the deepest areas of damage were on the inferior-proximal and superior-distal part of the necks, compatible with cantilever bending. Elemental analysis revealed chromium rich deposits indicative of corrosion processes and metal transfer from the stem to the neck.

There was a positive correlation between the severity of damage and time of implantation (p<0.0001). Co and Cr levels in the blood were also strongly correlated (p<0.0001, p=0.0002). No other implant or patient variables were linked.

The stem-neck junction was severely corroded in all cases. The severity and location of the areas of surface damage did not link with implant or patient characteristics in this big cohort suggesting that the design and material combination is the predominant source of failure in these designs.

Dual-taper hips are severely corroded at the stem-neck junction; this appears to be due to the use of a TMZF alloy stem paired with CoCrMo necks.

Trunnionosis, due to mechanical wear and/or corrosion at the head stem taper junction, can occur in metal on polyethylene (MOP) hip implants. In some patients this results in severe soft tissue destruction or Adverse Reaction to Metal Debris (ARMD). The amount of material required to cause ARMD is unknown but analyses of retrieved hips may provide the answer to this clinically important question.

We collected implants from 20 patients with failed hips with MOP bearings, revised due to ARMD. We collected clinical, imaging and blood test data. We graded the severity of taper corrosion (1 to 4), and quantified the volume of material loss from this junction. We compared our results with previous data collected for metal-on-metal (MOM) hips.

The median time to revision of the MOP hips was 51.3 (23.1–56.4) months. All head tapers were moderately to severely corroded with a median corrosion score of 4. The median (range) of total material loss at the taper of the MOP hips was 3.9 mm³ (2.96 – 7.85 mm³) and the material loss rate was 1.4 mm³ / year (0.56 – 1.82).

Comparison with MOM hips revealed no significant difference in taper material loss (p=0.7344) with a median rate of 0.81 mm³ / year (0.01–3.45).

We are the first to quantify the volume of material loss at the head taper of hip implants with MOP bearings that were revised due to trunnionosis. This data indicates that a clinically significant dose of cobalt and chromium to induce ARMD is approximately 1.4 mm³ / year.

We have identified a clinically significant volume of taper material loss in MOP hips.

Total hip arthroplasties are known to corrode predominantly at the taper junctions between Cobalt Chromium Molybedenum (CoCrMo) and Titanium (Ti) alloy components.

We aimed to understand the modes underlying clinically significant tissue reactions to metals from corroded implants by determining: (1) what type of metal is present in the tissues, (2) which cells contain the metal species and (3) how this compares with results from metal-on-metal (MOM) hip resurfacings (HRs).

This study involved periprosthetic tissue from patients that had undergone revision surgery due to adverse reactions to metal debris (ARMD) from dual-taper prostheses consisting of Ti-based alloy stems paired with CoCrMo necks. We used Synchrotron micro X-ray Fluorescence Spectroscopy (µXRF) and micro X-ray Absorption Near Edge Spectroscopy (µXANES) for detection of Co, Cr and Ti, and determination of their oxidation state.

Synchrotron radiation has shown that the chromium in tissues is Cr₂O₃ when derived from corroded CoCrMo/Ti junctions beside the CrPO₄ species found when hip implants release CoCrMo nanoparticles from their bearing surfaces (MoM HRs). Presence of Cr₂O₃ was associated with titanium oxide TiO₂. This may be the outcome of the chemical interaction between the two species. Histological examination showed corrosion products present within viable macrophages and in the extracellular connective tissue, Figure 1.

Understanding corrosion at taper junctions and the pathogenesis of the biological response is of significant clinical importance. This is the first study to co-register histology and metal distribution maps and to explore the potential synergy effect of CoCrMo with Ti alloy.

This study provides guidance for toxicological studies on wear/corrosion particles, how they stimulate the host response and the cellular mechanisms involved in the pathogenesis of ARMD.

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Objectives

The use of ceramic femoral heads in total hip arthroplasty (THA) has increased due to their proven low bearing wear characteristics. Ceramic femoral heads are also thought to reduce wear and corrosion at the head-stem junction with titanium (Ti) stems when compared with metal heads. We sought to evaluate taper damage of ceramic compared with metal heads when paired with cobalt chromium (CoCr) alloy stems in a single stem design.