Large-diameter Femoral Heads in Total Hip Arthroplasty an Evidence-based Review

Abstract

Full hip arthroplasty (THA) is widely considered one of the most successful surgical procedures in orthopaedics. It is associated with high satisfaction rates and significant improvements in quality of life following surgery. On the other hand, the main cause of late revision is osteolysis and wear, often a upshot of failure of bearing surfaces.
Currently, several options are available to the surgeon when choosing the bearing surface in THA (ceramic-on-ceramic (CoC), ceramic-on-polyethylene (CoPE), metal-on-polyethylene (MoPE)), each with advantages and drawbacks.
Very few studies have directly compared the diverse combinations of bearings at long-term follow-up. Randomized controlled trials show similar short- to mid-term survivorship among the all-time performing bearing surfaces (CoC, CoXLPE and MoXLPE). Selection of the bearing surface is often 'experience-based' rather than 'evidence-based'.
The aim of this paper is therefore to evaluate the main advantages and drawbacks of various types of tribology in THA, while providing practical suggestions for the surgeon on the nearly suitable bearing surface choice for each patient.

Cite this article: EFORT Open Rev 2018;3 DOI: 10.1302/2058-5241.3.180300.

Introduction

Total hip arthroplasty (THA) is widely considered to be ane of the about successful surgical procedures in orthopaedics. It is associated with high satisfaction rates and significant improvement in quality of life following surgery.^1,two According to recently published data from the British National Articulation Registry, the cumulative survival of THA at thirteen years is 93.2%, with 80% of implants surviving up to 20 years.^iii,4 Moreover, the number of THAs performed worldwide is increasing. Co-ordinate to the Australian Arthroplasty Registry, there was an increase of 5.5% betwixt 2015 and 2016, and an increase of 109.7% betwixt 2003 and 2016 in that country.⁵ In Italian republic, between 2001 and 2015, there was an annual increase charge per unit of 2.5% for THA performed.^half-dozen

While THA is a successful procedure in almost cases, failures are still recorded. Overall, excluding metal-on-metal (MoM) bearings from the analysis, failures due to articulating materials stand for around 5% of the full number of implants.^iii,5 When because just late failures, divers as the ones occurring after x years or more, osteolysis and implant wearable go the near common causes for revision when associated with aseptic loosening.^7,eight

The pathophysiological mechanisms of polyethylene article of clothing-induced osteolysis have been extensively studied.^nine-12 It has been shown that droppings particles tin induce a cellular response in periprosthetic tissues, with the upwards-regulation of cost-like receptors (TLRs) on macrophages. TLR signaling leads to up-regulation of many chemokines and cytokines, such equally TNF-α, IL-1β, MCP1 and others. The inflammatory response that ensues leads to the activation of osteoclasts and induction of local bone resorption.

Currently, several options are available to the surgeon when choosing the bearing surface in THA (Table 1). The nearly common material for acetabular liners is polyethylene (PE), either ultra-high molecular weight PE (UHMWPE) (the so-called 'standard' or 'conventional' PE) or cross-linked UHMWPE (XLPE), or ceramics or metallic; the latter nowadays abandoned and withdrawn from the market for THA.¹³ Heads can exist fabricated of ceramics or metallic alloys, usually CoCr (Cobalt-Chromium).^fourteen Thus, there are several combinations of liners and heads that tin be selected, each i with its own well-known advantages, but as well disadvantages (Table ane).¹⁵ Wear and osteolysis are described as occurring mainly with conventional PE bearings associated with metal or ceramic heads (MoPE or CoPE). XLPE has been reported with less article of clothing (MoXLPE or CoXLPE), but also with a subtract in mechanical proprieties; ceramic-on-ceramic (CoC) is related to much less wear and the highest bio-tolerability but carries the risk of breakage and noise from the implant following arthroplasty. Very few studies accept directly compared the various combinations of bearings at long-term follow-up. Randomized controlled trials (RCTs) show similar short- to mid-term survivorship amongst CoC, CoXLPE and MoXLPE in patients younger than 65 years.^sixteen Thus, clinical decisions on the choice of the bearing are still based on very express evidence.¹⁷

Table i.

Main disadvantages for each begetting surface

Couplings	Main disadvantage
Metal-on-polyethelene	Wear and osteolysis
Ceramic-on-polyethelene	Wear and osteolysis
Metal-on-XLPE	Decreased mechanical properties
Ceramic-on-XLPE	Decreased mechanical backdrop
Ceramic-on-ceramic	Breakage and squeaking
Metal-on-metal	ARMD (ALVAL, high ion levels, osteolysis, pseudotumours)

Notes: XLPE, highly cross-linked polyethylene; ARMD, adverse reaction to metallic droppings; ALVAL, aseptic lymphocyte-dominant, vasculitis-associated lesion

This approach is reflected by trends and usage percentages of begetting surfaces in major geographical areas: in the Usa the utilise of ceramic heads increased between 2012 and 2016, while the use of metal heads decreased (60% metal and 36.8% ceramic in 2012, to 42.6% metal and 52.8% ceramic in 2016).^xviii In Italian republic, the but available data refer to a single region, Emilia-Romagna: between 2001 and 2013 a steep increase in CoC coupling was observed (20.5% compared with 62.1%), associated with a decrease in metal caput usage (41.2% to 10.3%).¹⁹ Conversely, in the Britain, since the decline in usage of MoM bearings in 2010, an increase in CoP has been observed (12.ii% in 2010 to 32.7% in 2016; information refer to uncemented prostheses), with a decrease in CoC (39.5% to 24.nine%), while MoP couplings remained abiding.³ These data highlight a substantial difference in trends and overall percentage of pick of various bearings.

In this newspaper, a brief review of the chief advantages and drawbacks of various types of tribology in THA will be discussed, while providing applied suggestions for the surgeon on the almost acceptable bearing surface option for each patient, based as well on the all-encompassing personal experience of the authors.

Some definitions

It is helpful at this bespeak to consider and to clarify some definitions when considering bearings.

Tribology

The science that studies friction, lubrication and wear between two surfaces which are in close contact and move one on the other. The proper name is derived from the Greek discussion 'Τριβος,' which ways rubbing.

Wear

The surface damage with progressive loss of material (debris) due to friction betwixt moving surfaces.

Debris

Particles of unlike material and size shed from the surface of the various parts of the implant due to wear.

Fretting

Relative low aamplitude movement (oscillation and sliding) between two mechanically joined parts, under load conditions (between 1 µm and 100 µm). All modular junctions are susceptible to the loading of the body. It provokes wear (droppings) and corrosion.

Corrosion

Surface degradation due to electrochemical interactions producing metallic ions and salts which applies merely to metals. Dissimilar distinct forms of corrosion have been described (galvanic, fretting, fissure, stress, etc).²⁰

Osteolysis

Bone resorption due to biological response to debris including osteoclast activation that can compromise the bone stock around the implant and lead to loosening of the prosthesis in the advanced stage.

Conventional and cross-linked polyethylene

Conventional and cantankerous-linked polyethylene PE liners are the almost common choice in THA. UHMWPE was introduced in the early 1960s by Charnley, and was widely used until the last decade, when it has been progressively replaced by XLPE.

When considering PE liners, not only the fabric, but also the blazon of sterilization is of major importance for the mechanical backdrop and for the biological effects. Until the mid-1990s, the almost mutual sterilization method for UHMWPE was gamma irradiation. Whilst this method increases cross-linking between PE molecules, generating a more vesture-resistant material, when performed in presence of oxygen, it too produces complimentary radicals. Free radical oxidation makes PE more brittle, with reduced resistance and increased wear. Several studies highlighted how the use of a different sterilization method improves PE wear resistance.^21-23 Thermal sterilization with gas plasma has been shown to meliorate vesture and oxidation resistance in vitro when compared with gamma irradiation in the presence of oxygen. On the other hand, sterilization with gamma irradiation in an air-free environment and oxygen-complimentary packaging could theoretically reduce the risk of complimentary radical oxidation, while maintaining the increased cross-linking between PE molecules. In a 10-year follow-upwards study past Engh et al,²⁴ PE liners sterilized by oxygen-gratis gamma irradiation showed less head penetration and less osteolysis when compared with both gas plasma and gamma irradiation in air. Thus, when choosing or revising a PE liner, a knowledge of the sterilization method is necessary. Oxygen-free packaging in gamma-irradiated PE should be the preferred method, together with PE sterilized in ethylene oxide; currently these show good clinical long-term results and are preferred past many sterilization stakeholders.

In the terminal 15 years, conventional PE liners have been progressively abandoned in favour of XLPE liners. Currently, XLPE is used in the 98% of THAs in which a PE liner is selected.⁵ XLPE is divers as UHMWPE that has been irradiated with at to the lowest degree 50 kGy of gamma (or beta) or electron beam radiations. This treatment induces the cantankerous-linking between PE molecules, with the rationale of increasing wear resistance. In the last few years the first long-term follow-upwardly studies have been published, and reduced wear, together with a amend survival of XLPE when compared with standard PE were found.^25,26 The better long-term results with XLPE were confirmed by registry data in the 2017 Australian Registry report. The rate of revision at sixteen years for XLPE was 6.2%, compared with 11.seven% for not-XLPE.⁵ It is worth noting that a contempo study found an increment in habiliment charge per unit in XLPE compared with standard PE starting from the tenth twelvemonth of follow-up, thus raising a starting time business concern on the very long-term performance of XLPE.²⁷

The surgeon must keep in heed that not all XLPEs are the same, because that bated from irradiation, melting technique and annealing can also influence the in vivo proprieties of XLPE. XLPE liners annealed afterwards irradiation and below the melting temperature ordinarily show good wear and fatigue performances simply poor oxidation resistance; this happens because this process fails to neutralize all free radicals. On the other paw, XLPE liners re-melted after irradiation show expert oxidation resistance but less fatigue resistance.²⁸

The cross-linking procedure, while increasing the clothing properties of PE decreases the mechanical ones, making the liners more than at risk of fatigue fracture. The irradiation of PE generates complimentary radicals that can react with oxygen and could compromise the mechanical properties over time.²⁹ As a affair of fact, breakage of XLPE liners has been widely described in particular when one-time types of locking mechanism and designs were used.^30,31 Moreover, steep positioning of the acetabular component which leads to stresses concentration or impingement is considered a run a risk cistron.³²

Recently, XLPE liners with the addition of antioxidants such every bit Vitamin E were introduced into the market place with the aim of reducing the oxidation in vivo. The Vitamin E can be mixed in PE powder or added through diffusion afterward machining. The rationale for Vitamin E addition is to human action equally an antioxidant reacting with the free radicals that remain instead of oxygen.³³ In this way, re-melting is not necessary to avert the oxidation, and mechanical properties are saved. As a consequence, the liner can also be thinner and larger heads tin can be used, with a possible improvement in joint stability. While the early on clinical results are promising, with a low wear rate reported fifty-fifty with 36-mm diameter heads, the follow-up is all the same too curt to evaluate potential clinical advantages over regular XLPE liners^34-36 and registry data show no difference between XLPE and Vitamin E XLPE.^five

Because of the influence that the discussed elements have on in vivo performance of the PE liners, the surgeon must be enlightened of the called liner characteristics concerning sterilization and production processes, in guild to choose the optimal one for each patient.

Two other primary factors need to be considered when evaluating the long-term performance of a PE liner: the bore and the fabric of the femoral head. Larger diameter heads are associated with increased wear and revision rate for osteolysis when coupled with standard PE.^5,37 Interestingly, no increment in XLPE wear rate with the use of larger diameter heads (> 32 mm) was reported.³⁸ Moreover, skilful results with XLPE at a medium-term follow-upwards were reported even with the use of large diameter ceramic heads.³⁹ These observations were recently confirmed past registry data that reported a x-year survival of 95.3% of THA with XLPE and a femoral head > 32 mm.^five These data could allow surgeons to use larger femoral heads fifty-fifty when selecting a XLPE liner, but in standard routine cases no more than 36 mm is suggested co-ordinate to the acetabular component size for safety reasons, as there is a lack of information for head sizes larger than 36 mm. The thickness of XLPE should provide enough fatigue resistance to the components. For this purpose, the design must also exist considered. In our experience, we use larger femoral heads when we can select a XLPE liner with a minimum thickness of 6 mm, that means in acetabular components with a minimum size of 56 mm⁴⁰ (Fig. 1).

Concerning the choice of femoral caput, few data are bachelor, with only minor series and at short follow-up intervals^41,42 and no long-term follow-up RCTs directly comparing metallic versus ceramic heads coupled with XLPE.¹⁶ In a recent study past Cafri et al,³⁷ based on a systematic assay of registry data, an overall equal long-term operation was constitute between metallic and ceramic heads. Data from the Australian registry suggested a lower revision rate of CoXLPE when compared with MoXLPE.⁵ Theoretical advantages of the ceramic compared with the metal heads are: the higher hardness with less gamble of damage during implantation, the surface finishing with only negative peaks due to grains detachment rather than deformation, and the college wettability thus producing a better lubrication of ceramic which can lead to less friction and scratching and theoretically less liner clothing.⁴³ Moreover, alumina does non induce biological intolerance and it is considered to be the material with the best biocompatibility. On the other hand, several contempo studies reported the occurrence of adverse local tissue reactions to metal debris with the utilize of a metallic head coupled with PE liners, due to trunnionosis at the head/neck junction.^44-48 Patients adult soft-tissue impairment, pseudotumours, osteolysis and had higher blood metal ions levels. This occurrence is due to fretting at the taper/head junction, and was reported with implants of different manufacturers. In a retrieval study by Kurtz et al,⁴⁹ the fretting and corrosion at the taper/caput junction were evaluated either with ceramic and metal heads. Ceramic heads showed significantly less fretting and corrosion, independent of the stalk alloy used for the testing. Trunnionosis at the metal head-neck junction is a possible crusade of painful THA that needs to be excluded after ruling out other causes of failure such as infection, only at the moment the feeling is that information technology could be a somewhat overestimated event. No ane knows the real incidence of this phenomenon on a large scale and further research is needed.

Two potential limitations to the apply of ceramic heads are worth discussing: the run a risk of fractures and the increased costs. While a detailed caption of ceramic fracture mechanisms is given beneath, it must be noted that the hazard of caput fracture is lower than the risk of liner fracture and is reported as occasional and insignificant in combination with PE.⁵⁰ A clean date of the head in the stem taper is required to reduce fracture run a risk. Concerning the costs, ceramic heads are more expensive than metal heads. Notwithstanding, in a model that accounted for the increased chance of trunnionosis with metal heads, the routine use of ceramic heads has showed comparable cost-effectiveness to metal heads.⁵¹ No population-based studies have estimated the real-life cost-effectiveness of routine ceramic head use. With the increasing use of ceramic heads, we can expect that the price will decrease and, at the same price equally metallic heads, there should be no objections to the claim that CoXLPE could be preferable to MoXLPE.²

Ceramicized metal (Oxynium)/XLPE is the bearing surface with the highest survival at ten years in the Australian Registry,^v but the Registry written report advice is to interpret this result with caution. The reason is that this is a single company product, used with a modest number of cases. This may take a confounding effect on the effect, compared with the other begetting surfaces used in many different combinations.

In our clinical practice, XLPE liners with ceramic heads are the first selection in older patients, or in younger patients when a reliable correct positioning of the acetabular component cannot be obtained intra-operatively due to anatomical abnormalities.

Ceramic on ceramic

The other option among the best performing bearing surfaces is CoC. The beginning ceramic acetabular components were introduced in the 1970s by Pierre Boutin in France every bit cemented liners and in 1974 by Heinz Mittelmeier in Germany every bit cementless threaded liners and skirted heads. However, this generation of ceramics was characterized by a high rate of aseptic loosening and failure due to the poor fixation of both cemented and cementless implants, inadequate designs such as the bulky skirted heads and the forcefulness issues due to the grain size of the start generation of alumina. Modern ceramic acetabular components featured titanium shells with rough surface finishing in which a ceramic liner is located while in the 1990s the alumina farther improved to a higher purity class with more uniform and smaller grains. This type of implant has a large number of long-term follow-up studies, with adept to excellent clinical results.^52-54

Nowadays the most commonly used ceramic is the alumina matrix composite (AMC) (Biolox Delta; CeramTech AG, Plochingen, Germany). In 2016, AMC accounted for 92.0% of all procedures with CoC bearing surface in the Australian Registry.⁵ AMC, introduced in the early on 2000s, is the fourth generation of Biolox Ceramics, composed of 82% alumina and 17% zirconia, with the addition of chromium oxide (0.five%) to enhance hardness and strontium crystals (0.5%) to diffuse crack energy. This textile has a smaller grain size (< 0.8 µm) compared with previous ceramics, and was developed in order to reduce the chance of implant fractures. In the last few years mid- to long-term follow-up studies of AMC have been published, with a ten-year survival rate from 98% to 99.three% at ii to ten years.⁵⁵ These first-class results are confirmed by registry information: the Australian Registry reports a CoC survival of 92.8% at 15 years.^five

When compared with XLPE, CoC bearings have some advantages worth noting. The first advantage is the very low friction and very low wear rates. This is due to the hardness and high wettability of the surface, as mentioned above, of the ceramic heads. Moreover, the few wearable particles generated past ceramic components induce a less intense biological reaction compared with polyethylene debris. Histological analysis of long-term retrievals indeed found wear debris in private macrophages, but the inertness of such debris does not trigger the granulomatous reaction necessary to induce osteolysis. A second reward of CoC bearings is that article of clothing is not straight dependent on the head diameter. This allows the surgeon to select a larger diameter head with fewer concerns compared with PE liners. The AMC liner can too be thinner (3 mm to 4 mm) compared with XLPE ones. Registry data^three show that when using a CoC coupling, larger diameter heads (36 mm) have significantly better survival rates at xiv-twelvemonth follow-up when compared with smaller heads (32 mm), while 28 mm heads have the highest revision rate, mainly in the starting time years after surgery. The 40 mm heads accept a proficient survival, similar to 36 mm, just the follow-up is still too brusque, suggesting that these results should be interpreted with circumspection. These observations could be explained by a reduced risk of dislocation with the use of larger heads.

CoC bearings have some drawbacks that limit their widespread apply. The first limitation of ceramics is the brittleness of the material that increases the risk of fracture. Ceramic fracture is indeed a catastrophic complication that tin occur with the utilize of such material. With modern ceramics, studies report only occasional occurrence of fracture of the head, with higher run a risk of occurrence in the curt neck 28-mm head.⁵⁶ Liner fracture has been reported with a college frequency, with percentages betwixt 0.13% to 1.i%, with differences among metal-backed brands.^57,58 Liner fractures are almost never related to direct trauma, but rather depend on three principal mechanisms: misalignment during insertion of the liner, metal back damage or acetabular component malposition that leads to impingement and edge-loading. Excessive anteversion (> 25°) has been demonstrated as the chief clinical risk factor for liner fracture due to impingement.⁵⁹

Correct positioning and handling of the components is very sensitive in the case of CoC, which has a very low clothing bearing surface, but is less forgiving. Also, metal back deformation^lx during the insertion is critical every bit titanium shell can deform during impaction, consequently generating a 2-indicate support of the liner to which ceramics are vulnerable.⁶¹ Thus, careful preparation of the acetabulum and assessment with a trial insert is required when using a ceramic liner. Non all the metal backs are the aforementioned in terms of thickness, stiffness and tools for implantation. A pocket-sized alter tin crusade a big deviation during engagement of the taper of the ceramic liner in the beat. This could be due to a flawed blueprint of the components or to a surgical mistake. Over again, intra-operatively each implant must exist checked for right date of the liner in the metal back prior to the definitive reduction of the prosthesis.

The second disadvantage of CoC bearings can be the occurrence of noises such as squeaking. Similar to ceramic liner fractures, there is a nifty variety of incidence (from 0% to 35%) among different metallic back manufacturers reported in the literature.^62,63 Several gamble factors take been identified, such equally historic period, obesity, activeness level and acetabular component positioning.^64-66 The perception of European surgeons is generally that this event is overestimated past colleagues practising outside Europe. In our clinical practice, we observe frequent cases of post-operative noises caused past the separation of the head from the liner due to post-operative soft-tissue laxity, such as clicking, knocking, popping and snapping, that resolve spontaneously in a few weeks, with only a few occasional typical squeakers. In these cases, the racket is caused past the friction of the components. The retrievals show ceramic grains detached from the head and the liner, which means dulling of the surface, edge-loading and habiliment (45 times greater than silent retrievals).^67,68 The occurrence of a new delayed noise in a ceramic articulation, peculiarly if linked to pain and malposition, must be carefully considered every bit it can be acquired by breakage and habiliment of the ceramics that practise not normally improve.⁶⁹ Nonetheless, the phenomenon has a multifactorial origin, sometimes with conflicting features from published studies. The outcome and patient satisfaction are non affected.

For the aforesaid risks linked to malposition and soft-tissue balancing, the use of CoC has a possible contra-indication in our do in young patients, in the few cases when it can exist hard to reach the right orientation of the acetabular component and off-set, such as astringent developmental dysplasia of the hip or mail service-traumatic acetabular deformity. Patients showing weakness of the pelvic muscles, soft-tissue laxity or excessive range of movement should likewise be considered at risk.^seventy In our clinical practise, CoC is the begetting of choice in younger and more active patients.

Metal on metal

Metal on metal THA has a long history which began in the 1950s and 1960s in the United Kingdom with McKee-Farrar. In the 1980s, small MoM heads (28 mm and 32 mm) by Weber and Semlitsh became quite popular, fifty-fifty if they never gained a major office in the market. Acceptable results are reported with pocket-sized MoM heads both by registries³ and clinical studies at medium- to long-term follow-upward.^71-74 Unfortunately, due to the high rate of failure and of agin reactions to metal droppings following the MoM big heads introduced in the heart of the 2000s and despite the early on favourable consequence of hip resurfacing, MoM THA is present almost entirely abandoned by surgeons and completely withdrawn from the market past manufacturers, including small heads. This bearing surface is no longer an option and the issue nowadays is how to follow-up patients implanted with MoM in the past.^xiii

Conclusions

THA is overall a very successful procedure. The long-term survival and satisfaction of patients is linked to the proper bearing surface choice. The surgeon has a responsibility to make a wise option, based on a comprehensive knowledge of the features of the selected bearing.

Based on the in a higher place-mentioned concepts and departmental feel, our choice of indication regarding the joint in primary standard cases of THA has not changed since 2004. It is:

below the historic period of 60 years: CoC (32 mm or 36 mm depending on the acetabular component size and on the metallic back thickness; 40 mm is selected nowadays only in cases of large acetabula at higher risk of dislocation in the middle-anile population but not in very immature patients);
over the age of 65 years: CoXLPE (28 mm, 32 mm or 36 mm depending on the acetabular component size and on the risk of dislocation of the patient. In high-risk patients, dual mobility acetabular components are used);
between 60 and 65 years: depending on the patient'due south activity; CoC is selected for more active and enervating patients;
weight and torso mass index do not influence the choice of the bearing, whilst in cases with major anatomical deformities, pre-operative high range of movement and soft-tissue laxity, CoC is used carefully – even if the patient is young.

MoXLPE is, of class, a valid alternative bearing option, since as nevertheless at that place is no long-term testify on the superiority of 1 bearing surface over the others among the three all-time performing PEs (MoXLPE, CoXLPE, CoC). We personally do not see whatsoever reason for using a metal head instead of a ceramic one other than cost.

When choosing the surface bearing, the surgeon must keep in mind that non all XLPEs are the same; the dimension changes with different acetabular components and head size but a minimum thickness must be preserved. Too, the ceramics are not always the same, and in the example of CoC the metallic-back features (thickness, shape, surface finishing, press fit) and implantation tools can brand a dandy divergence. These features differ from one brand to some other. Concerning hard bearings, clinical studies on large numbers and registry data are not all the same able to evaluate whether wear performances are influenced past surgical technique, the handling and the position of the components, the acetabulum size, the hardness of the os, the presence of osteophytes, the soft-tissue balancing or restoration of the beefcake. For these reasons, proper grooming for the surgeon who is willing to employ difficult bearings such as ceramics should be mandatory.⁷⁵

In determination, a comprehensive cognition of the characteristics, advantages and drawbacks of each bearing surface is essential for surgeons who routinely perform THA. This, forth with personal experience, will help in selecting the best coupling for each patient in lodge to provide the all-time long-term survivorship of the prosthesis. In our feel, CoC in young and active patients (for the college vesture resistance and biocompatibility) is a good pick. CoXLPE and MoXLPE are a valid option for 'older' patients (more 'forgiving' bearings, and skilful results are reported at xv years). Moreover, surgeons must remember that what makes the difference is not just the material, simply the right surgical technique and treatment of the components – mainly the positioning of the implant.

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