Performance of metal-on-metal (MOM) bearings was of great interest until recently. Major concerns emerged over high incidence of MOM-wear failures and initially there appeared greater risks with MOM total hip arthroplasty (THA) designs compared to resurfacing arthroplasty (RSA). Impingement of the metal neck against the THA cup was likely the differentiating risk. There is a major difference between RSA and THA in (i) size of femoral necks and (ii) risk of THA metal necks impinging on metal cups. For example, a 46mm THA with 12.5mm neck, a 3.68 head:neck (H/N) ratio, provides a suitably large range-of-motion (ROM). In contrast, an RSA patient with retained 31mm size of natural neck would only have H/N = 1.48, indicating even less ROM than a Charnley THA. However, the enigma is that RSA patients have as good or better ROM in majority of clinical studies. We studied this apparent RSA vs THA dilemma by examining MOM retrievals for signs of adverse impingement. We previously described CoCr stripe wear in failed THA bearings, notably alignment of polar and basal wear stripes coincident with the rim profiles of the cups (Clarke 2013). Our governing hypothesis was that RSA patients had to routinely sublux their hips to get ROM comparable to THA. Our THA impingement studies showed polar stripes within 15o of the polar axis in large heads. For the various RSA diameters, we calculated that wear stripes angled 40o from the femoral axis could indicate impingement with no subluxation, whereas smaller angles would indicate routine subluxation of RSA femoral-shell from cup. We compared explanted RSA (N=15) and THA (N=15) bearings representing three vendors (42–54mm diameters). Wear maps and head-stripes were ink-marked for visualization, photography, and analysis. Wear areas were calculated using spherical equations and wear-stripe angles measured by computer graphics.

The results showed that RSA femoral shells had wear areas circular in shape with areas varying 1,085- 3,121mm2. These averaged 14% larger than in matched THA heads but statistically significant difference was not proven. Polar stripes were readily identifiable on femoral components, 75% for RSA cases and 100% for THA. These contained identical linear scratches and all were sited within 30o of neck axis, confirming our hypothesis that RSA patients had to sublux their hips to achieve same motion as THA. Examination of cup wear areas revealed all showed ‘edge-loading’, but RSA cups had a significantly greater degree.

Retrieval studies are limited by uncontrolled case sources, varied brands, and small numbers. In this study, we were able to match RSA and THA cases by vendor and diameter. The RSA retrievals revealed polar stripes identical to THA by site, topography and inclination to femoral-neck axis. This confirmed our starting hypothesis and explained the large clinical ROM available in RSA patients. The larger wear areas on RSA femoral shells, although not statistically significant, and the larger ‘edge loading’ sites in RSA cups appeared as further support for routine subluxation of femoral-shells during hip impingement.

This study presents an unusual recurrent case of pigmented villonodular synovitis (PVNS) around a ceramic-on-metal (COM) hip retrieved at 9-years. PVNS literature relates to metal-polyethylene and ceramic-ceramic bearings. Amstutz reported 2 cases with MOM resurfacing and Xiaomei reported PVNS recurring at 14 years with metal-on-polyethylene THA. Friedman reported on PVNS recurrence in a ceramic THA. Ours may be the first reported case of recurrent PVNS of a ceramic-on-metal articulation.

This young female patient (now 38-years of age) had a total hip replacement in 2006 for PVNS in her left hip. In her initial work-up, this case was presumed to be a pseudotumor problem, typical of those related to CoCr debris with high metal-ion concentrations. She had an CoCr stem (AML), 36mm Biolox-delta head (Ceramtec), and a Pinnacle acetabular cup with CoCr liner (Ultramet, Depuy J&J). This patient had no concerns regarding subluxation, dislocation or squeaking. Three years ago she complained of mild to moderate groin and thigh pain in her left hip. This worsened in the past year. She noticed increased swelling now with an asymmetry to her right hip. She went to the emergency room in Dec-2014 and was referred to a plastic surgeon. In our consult we reviewed MARS-MRI and CT-scans that demonstrated multiple mass lesions surrounding the hip. Laboratory results presented Co=0.7, Cr=0.3 ESR=38 and Crp=0.3.

At revision surgery, the joint fluid was hemorrhagic/bloody with hemosiderin staining the soft tissues. Multiple large 4–5×5cm nodules were present in anterior aspect of the hip as well as multiple nodules surrounding posterior capsule and sciatic nerve. Pathology demonstrated a very cellular matrix with hemosiderin-stained tissue and multiple giant cells, which was judged consistent with PVNS. The trunnion showed no fretting, no contamination and no discoloration. The superior neck showed impingement due to low-inclination cup. There was minimal evidence of metal-debris staining the tissues. There was a large metallic-like stripe across the ceramic head.

This is a particularly interesting case and may be the first reported recurrent PVNS around a ceramic-on-metal bearing (COM). Data is scant regarding clinical results of COM bearings and here we have a nine-year result in a young and active female patient. She was believed to have a metalosis-related pseudotumor yet her metal-ion levels were not alarmingly high and there was no particular evidence of implant damage or gross wear products. In addition, the CoCr trunnion appeared pristine. Our work-up continues with analyses of wear and histopath-evidence. This case may demonstrate the need for a broadening of the differential diagnosis when dealing with hip failures.

Metal-on-metal retrieval studies indicated that MOM wear-rates could rise as high as 60–70mm3/year in short-term failures (Morlock, 2008). In contrast, some MOM and ceramic-on-ceramic (COC) devices of 1970's era performed admirably over 2–3 decades (Schmalzreid, 1996; Shishido, 2003). While technology has aided analysis of short-term MOM and COC failures (Morlock 2008; Lord 2011), information on successful THA remains scant. Lack of long-term data creates difficulties in setting benchmarks for simulator studies and establishing guidelines for use in standards. In this study we compared clinical and wear histories for a 30-year MOM and a 32-year COC to establish such long-term, wear-rates.

The McKeeTM retrieval was cemented and made 100% of CoCr alloy (Fig. 1a). This patient had a right femoral fracture at 47 years of age, treated by internal-fixation, which failed. Her revision with a Judet implant also failed, leaving her right hip as a Girdlestone. At the age of 68, she had a McKee THA implanted in left hip, and used it until almost 98 years of age (Campbell, 2003). The COC case was a press-fit AutophorTM THA, head and cup made of alumina ceramic, with the only metal being the CoCr stem (Fig. 1c). This was implanted in a female patient 17-years of age active in sports (water-skiing). This modular THA was revised 32-years later due to hip pain from cup migration. Wear on these implants was identified by stereomicroscopy and stained red for photography (Fig. 1). Cup-to-neck impingement was denoted by circumferential neck notching, roughness was assessed by interferometry, and wear determined by CMM (Lord, 2011).

McKee head wear covered 1092mm2 area (Figs. 1a, 2: hemi-area ratio 58%). There was no stripe wear and head roughness was 36nm (Ra). Cup wear covered an area of 1790mm2 (hemi-area 63%). Circumferential damage was noted on the supero-posterior femoral neck with scuff marks also on posterior collar (Fig. 2c). Head and cup wear amounted to 37.7 and 25.2mm3, respectively. Total MOM wear was 62.9mm3, indicating a wear-rate of 2.1mm3/year.

Ceramic head wear consisted of two circular patterns (Fig. 1c), the major one of area 1790mm2 (hemi-area 79%). No wear stripes were identified. Non-worn and extensively worn surfaces had roughness (Ra) 17nm and 123nm, respectively. The cup showed 360o circumferential arc of rim wear with a small, non-wear zone inferiorly (Fig. 1c). Gray metallic transfer was evident, EDS revealing Co and Cr (Fig. 3a). Head and cup wear volumes were 77.2 and 54mm3, respectively. Total COC wear amounted to 131.2mm3 indicating a wear-rate of 4.1mm3/year.

These two THA functioned successfully over 3 decades. The McKee retrieval had minor signs of impingement but no adverse “stripe wear”. This MOM performed satisfactorily due to good positioning and patient's advanced age (68 to 98Yrs of age). The COC patient was 17 years of age at index surgery and active. The ceramic cup showed 360o of edge wear, CoCr transfer and a COC wear-rate double that of the MOM retrieval. Thus the high ceramic wear-resistance protected this youthful patient.

The purpose of this study was to determine the survivorship for a MOM implant series performed by a single community surgeon followed using a practical clinical model. A retrospective cohort of 104 primary MOM THA procedures (94 patients) were all performed by one surgeon at three local hospitals now with 10–13 years follow-up. Sixteen patients are deceased and 16 patients have been lost to follow-up. In the remaining 62 patients, 8 are bilateral providing a total of 70 THA for study. The clinical follow-up model included: hip scores, X-rays, ultrasound, and metal ion concentrations (Co, Cr, Ti). Due to the diversity of patient location, a variety of clinical labs were utilized for metal ions. Statistical methods included Kaplan-Meier survival curve and One-way ANOVA. Hip scores were available for 70 THA and of these 61 had a hip score (HHS) above 80 (87%). X-rays were available for 49 hips and of these 38 (78%) had lateral/version angles in the safe zone (Fig 1: inclination ≤ 55 and anteversion ≤ 35). Thirty-eight ultrasound exams were performed and of these three yielded fluid collections (8%). Metal ion concentrations were documented in 39 of 62 patients (63%, either serum or whole blood). Six outliers were identified with high concentrations of metal ions (Fig 2); Co 0.3–143.9 ppb (median 3.6), Cr 0.2–200.3 ppb (median 2.2) and Ti 2-110 ppb (median 54). Six patients were revised by the original surgeon. Three of six with elevated ions were documented as wear problems and the other three were revised for infection, femur fracture and metal-ion sensitivity. The survivorship of 92.5% at 10 years (Fig. 3) may be partly due to the exclusive use of antero-lateral approach performed by one surgeon with 78% of cups well placed and the MOM design used exclusively.

Retrieval studies of metal-on-metal (MOM) resurfaced hips revealed cup “edge wear” as a common failure mechanism [Morlock-2008]. Retrieval analysis of total hip arthroplasty (THA) also demonstrated extensive rim wear (Fig. 1: 190–220o arcs), typically across the superior cup [Clarke-2013]. Such wear patterns have not been demonstrated in hip simulator studies. The simulator “steep cup” models typically had motion arcs (flexion, etc.) input via the femoral head [Leslie-2008, Angadji-2009]. With fixed-inclination cups this produces constant loading of cup rim against the head (Fig. 2a). This is unlikely to be the physiological norm, unless patients walk constantly on the rims of mal-positioned cups. More likely the patients produce edge-wear intermittently due to functional and postural variations. Therefore a novel simulator model is proposed in which the cup undergoes edge-wear intermittently at one extreme of flexion (Fig. 2a). Our study objective using this new simulator model (Fig. 2a, b) was to (i) demonstrate MOM wear-rates and wear patches as a function of these dynamic-inclinations (40 o, 50 o, 70o), and (ii) compare the simulator data to MOM retrievals (Fig. 1).

Two simulator studies were run, both using 60mm MOM. Four bearings were run to 1-million cycles (1Mc) with cups peaking at 40 and 50° dynamic-inclinations, thus providing control data with no edge-wear. In 2nd study, 4 MOM were run with cups given a dynamic-inclination of 70° to produce edge-wear effects. In study-2 currently at 2.5Mc duration, the femoral heads showed the two classical wear phases with run-in at 1.7mm³/Mc and steady-state at 0.084mm³/Mc (Fig. 3a). Wear-rate for cups at 2.34mm³/Mc was 40% higher than heads and continued to rise linearly with time (Fig. 3a). At 2.5Mc, cup wear averaged ×5.7 greater than heads and resulting wear-patterns extended 85°−225° around cup rim (Fig. 3b: average 151°). In study-1, wear patches in cups with 40° dynamic-inclination approached within 12.4mm of the cup rim as denoted by circumferential grooves. This margin-of-safety (MOS) represented a 24°angle. The cup wear-patch averaged area of 1,760mm2. With cups run at 70o dynamic-inclination, the wear patches were transferred an additional 30o towards the rim thereby representing a 6° transfer across the rim.

This is the 1st wear study to use the new dynamic-inclination test mode to better simulate cup function in vivo. It was particularly satisfying to see the similarity in wear-patterns between retrieval (Fig. 1) and simulator cups (Fig. 3b). It is also the 1st study to monitor sites and magnitudes of cup wear areas and to purposely produce “edge wear”. The cups with 40° and 50° dynamic-inclinations had large margins of safety. With 70° dynamic-inclination the margin of safety was lost - effectively there was a 6° transfer of the wear patch across the cup rim. Even this apparently small effect at one location in each gait cycle sufficiently perturbed MOM performance that wear increased by an order of magnitude. Notably this was all cup wear and not by femoral head participation. The study continues but at 2.5Mc duration the cups revealed 5-fold greater wear than heads.

Metal-on-metal (MOM) retrieval studies have demonstrated that CoCr bearings used in total hip arthroplasty (THA) and resurfacing (RSA) featured stripe wear damage on heads, likely created by rim impact with CoCr cups.^1-3 Such subluxation damage may release quantities of large CoCr particles that would provoke aggressive 3^rd-body wear. With RSA, the natural femoral neck reduces the head-neck ratio but avoids risk of metal-to-metal impingement (Fig. 1).⁴ For this study, twelve retrieved RSA were compared to 12 THA (Table 1), evaluating, (i) patterns of habitual wear, (ii) stripe-wear damage and (iii) 3^rd-body abrasive scratches. Considering RSA have head/neck ratios much lower than large-diameter THA, any impingement damage should be uniquely positioned on the heads.

Twelve RSA and THA retrievals were selected with respect to similar diameter range and vendors with follow-up ranging typically 1–6 years (Table 1). Patterns of habitual wear were mapped to determine position in vivo. Stripe damage was mapped at three sites: polar, equatorial and basal. Wear patterns were examined using SEM and white light interferometry (WLI). Graphical models characterized the complex geometry of the natural femoral neck in coronal and sagittal planes and provided RSA head-neck ratios.⁴

Normal area patterns of habitual wear were similar on RSA and THA bearings. The wear patterns showing cup rim-breakout proved larger for RSA cups than THA. Polar stripes presented in juxtaposition to the polar axis in both RSA and THA (Fig. 1). As anticipated, basal stripes on RSA occurred at steeper cup-impingement angles (CIA) than THA. The micro-topography of stripe damage was similar on both RSA and THA heads. Some scratches were illustrative of 3^rd-body wear featuring raised lips, punctuated terminuses, and crater-like depressions (Fig. 2).

Neck narrowing observed following RSA procedures may be a consequence of impingement and subluxation due to the small head-neck ratios. However, lacking a metal femoral neck, such RSA impingement would not result in metal debris being released. Nevertheless it has been suggested that cup-to-head impingement produced large CoCr particles and also cup “edge wear” as the head orbits the cup rim.⁴ Our study showed that impingement had occurred as evidenced by the polar stripes and 3^rd-body wear by large hard particles as evidenced by the wide scratches with raised lips. We can therefore agree with the prior study, that 2-body and 3rd-body wear mechanisms were present in both RSA and THA retrievals.

Introduction

Over 40-years the dominant form of implant fixation has been bone cement (PMMA). However the presence of circulating PMMA debris represents a 3rd-body wear mechanism for metal-on-polyethylene (MPE). Wear studies using PMMA slurries represent tests of clinical relevance (Table 1). Cup designs now use many varieties of highly-crosslinked polyethylene (HXPE) of improved wear resistance. However there appears to be no adverse wear studies of vitamin-E blended cups.1–4 The addition of vitamin E as an anti-oxidant is the currently preferred method to preserve mechanical properties and ageing resistance of HXPE. Therefore the present study examined the response of vitamin-E blended liners to PMMA abrasion combined with CoCr and ceramic heads. The hip simulator wear study was run in two phases to compare wear with, (i) clean lubricants and (ii) PMMA slurries.

Introduction

Looking for optimal solutions to wear risks evident in total hip arthroplasty (THA), silicon nitride ceramic bearings (Si₃N₄) are noted for demanding high-temperature applications such as diesel engines and aerospace bearings. As high-strength ceramic for orthopedic applications, Si₃N₄ offers improved fracture toughness and fracture strength over contemporary aluminas (Al₂O₃). Our pilot studies of Si₃N₄ in 28mm diameter THA showed promising results at ISTA meeting of 2007.¹ In this simulator study, we compared the wear resistance of 40mm to 28mm diameter Si₃N₄ bearings.

The 28mm and 40mm bearings (Fig. 1) were fabricated from Si₃N₄ powder (Amedica Inc, Salt Lake City, UT).¹ Wear tests run were run at 3kN peak load in an orbital hip simulator (SWM, Monrovia, CA) and. The lubricant was standard bovine serum (Hyclone: diluted to 17 mg/ml protein concentration). Wear was measured by gravimetric method and wear-rates calculated by linear regression. SEM and interferometic microscopic was performed at 3.5-million cycles (3.5Mc) to 12Mc.

The simulator was run to 3.5Mc duration with no consistent weight-loss trends. The bearings could show either small positive or negative weight fluctuations in an unpredictable manner (Fig. 2). Surface analysis showed protein layers up to 3μm thick, furrowed due to abrasion by small particles (Fig. 3). The low ceramic wear was camouflaged by protein contaminants alternatively forming and shedding. From 3.5 to 12.8Mc duration we experimented with various detergents and wash-procedures, all to no avail. Protein coatings were also more prevalent on 44 mm heads, likely due to frictional heating by the larger diameter effect. Selected heads were washed with a mild acid solution - the cumulative effect appeared to be removal of some protein layers, but not in a predictable manner.

The Si₃N₄ ceramic is used in demanding industrial applications and it is therefore unfortunate that we are yet not able to quantify the actual wear performance of Si₃N₄/ Si₃N₄ bearings (COC). The contaminating protein layers combined with low-wearing silicon nitride obscured the actual wear data. This has also been a problem in prior studies with alumina and zirconia bearings. Considerable challenges still stand in the way of the optimal biomaterials choices that will result in reduced risk of failure while providing extended lifetimes. Thus important issues remain unsolved and call for innovative solutions. Searching for a more effective ‘wear-measurement’ remedy, we noted that abrasive slurries of bone cement (PMMA) used in contemporary simulator studies were effective in promoting adverse wear in polyethylene bearings. These investigations also revealed that PMMA debris did not damage CoCr heads^2,3, alumina heads^4,5 or diffusion-hardened zirconia heads (ZrDH).⁶ We can therefore speculate at this ISTA meeting of 2014 that future ceramic wear tests should incorporate PMMA slurries. Here a new hypothesis can be formulated, that PMMA particulates will provide a continual and beneficial removal of contaminating proteins from the ceramic surfaces (see Fig. 3) and thereby aid definition of low-wearing COC bearings such as Si₃N₄.

The application of non-oxide ceramics such as silicon nitride presented here may become a viable alternative for THA designs of next decade.

Introduction

Hip simulators proved to be valuable, pre-clinical tests for assessing wear. Preferred implant positioning has been with cup mounted above head, i.e. ‘Anatomical’ (Figs. 1a-c) ^1,2 while the ‘Inverted’ test (cup below head) was typically preferred in debris studies (Figs. 1d-f).^3,4 In an Anatomical study, wear patterns on cups and heads averaged 442 and 1668 mm² area, respectively, representing 8% and 30% of available hemi-surface (Table 1), i.e. the head pattern was ×3.8 times larger than cup. This concept of wear patterns is illustrated well in the ‘pin-on-disk’ test (Fig. 1) in which the oscillating pin has the ‘contained’ wear area (CWP) and the large wear track on the disk is the ‘distributed’ pattern (DWP). Hip simulators also create CWP and DWP patterns, site dependant on whether Anatomical (Fig. 1a-c) or ‘Inverted’ (Fig. 1d-f) test. However there is scant foundation as to clinical merits of either test mode. Retrieval studies of MOM bearings have indicated that cups have the larger wear patterns, i.e. contrary to simulator tests running Anatomical cups (Table 1).⁵ Therefore we compared Anatomical and Inverted cup modes using 38mm and 40mm MOM in two 5-million cycle simulator studies.

A 35-year-old female (age 35Yrs) had primary MOM total hip arthroplasty (THA) in 2008. At 8 months this patient postoperatively developed headaches, memory loss, vertigo, and aura-like symptoms that progressed to seizures. At 18 months review, she complained of progressive hip pain, a popping sensation and crepitus with joint motion. This patient weighed 284lbs with BMI of 38.5. Radiographs revealed the cup had 55° inclination, 39° anteversion (Fig. 1). Metal ion concentrations were high (blood: Co=126 mcg/L, Cr= 64mcg/L). Revision was performed in November 2010 A dark, serous fluid was observed, along with synovitis. The implants were well fixed and the femoral head could not be removed; thus the stem was removed by femoral osteotomy. With the head fused on this femoral stem, for the 1^st time it was possible to precisely determine the habitual patterns of MOM wear relative to her in-vivo function. We investigated (1) size and location of wear patterns and (2) signs of cup-stem impingement to help explain her symptoms developed over 32 months follow-up.

The retrieved MOM was a Magnum™ with head diameter 50mm and 50×56mm cup (Biomet). This was mounted on a Taperloc™ lateralized porous-coated stem. Components were examined visually and wear damage mapped by stereo-microscopy, interferometry, CMM, SEM, and EDS. Main-wear zone (MWZ) areas were calculated using standard spherical equations¹ and centroidal vectors determined.

The head-cup mismatch was 427um with the cup revealing a form factor of 228um. The cup showed wear area of 1275mm² that extended up to the cup rim over 150°arc. The cup rim was worn thin over a 90° arc with loss of cup bevel. The head showed an elliptical wear area of 2200mm² located centrally on the superior-medial surface (ellipsoidal ratio ×1.2). Compared to the hemispherical surface (50mm: hemi-area = 3927mm²), the worn area represented hemi-area ratio of 56%. The centroidal vectors measured 8° anterior and 24° superior to the head's polar axis (Fig. 2). Stripe wear damage revealed multiple impingement sites. SEM and EDS revealed stripes were contaminated by metal transfer from the stainless-steel instruments used at revision. The main impingement position was identified (Fig. 3) indicating the site of repetitive subluxations whereby the subluxing head thinned the cup, i.e. “edge wear”.

Cup and head wear patterns corresponded well, reinforcing our definition of the MWZ locations in vivo. The femoral MWZ was centrally located superiorly and medially with respect to the polar axis of the femoral neck and head. The noted impingement position indicated this patient had experienced repetitive subclinical subluxations (RSS).² The taper inside the fused head may also have been a contributory factor that we cannot ignore. Nevertheless her excessive cup thinning was likely a result of a steep cup and considerable anteversion allowing the femoral head to sublux over the cup rim, thus thinning the cup and wearing the rim bevel, and producing MOM wear debris.

The relevance of fluid-film lubrication, elasto-hydrodynamic lubrication and ‘tribolayers’ for hip bearings has been the subject of much debate (Fisher 2012). However, knowledge of the thickness and distribution of proteins in and around the wear zone of metal-on-polyethylene (MPE) bearings is scant. The efficacy of protein lubrication with metal-on-metal bearings (MOM) is in discovery. This simulator study was designed to analyze film formation on MOM bearings using varied protein concentrations. The hypotheses were that increasing protein concentrations in the serum lubricant would result in 1) greater thickness of protein films, and 2) reduced MOM wear.

The hip simulator was run for 5 million cycles (5 Mc) duration using 28 mm MOM bearings (DJO Inc) run with the cups anatomical. Lubricant protein concentrations were 16.5, 33, and 66 mg/ml. At each test interval of 1 Mc, the proteins films on CoCr surfaces were analyzed by both interferometry and SEM imaging in main-wear, transition-wear and non-wear zones. Thickness of protein films was measured using non-contacting interferometry. Areas of wear zones were mapped and measured and the areas compared. MOM wear rates were assessed gravimetrically.

It was found that the proteins formed two types of film (Figure 1). Type-1 was visually hazy in appearance, grainy in structure, and most commonly found in the main-wear zone. This type of protein film was always present in the main-wear zone but its thickness (approximately 0.05 μm) did not increase with increase in the lubricant protein concentrations. Type-2 was visually rainbow-like in appearance, more gel-like with thick clumps appearing as islands on the CoCr surfaces, and more common in the transition zone. This type of film was always present (approximately 1 μm thick) and its thickness notably increased in cups with increased lubricant protein concentrations. This film remained relatively consistent on femoral heads and did not change with increased protein concentrations (Figure 2).

The type-1 protein films were always detectable in the actual wear zones but only the type-2 film showed a build-up with protein concentration and only inside the cups. This may be partially a response to the orbital simulator set up. In the Anatomical test mode, the cup is fixed with respect to the load axis and the head oscillates. Thus the main-wear zone on the head had a distributed type of wear patch and the main-wear zone in the cup was fixed. This configuration would allow the type-2 proteins to accumulate around the edge of the cup wear zone. In contrast, they would be scraped off the wear zone of the orbiting femoral head. This study showed that protein films endure even inside the main-wear zone of MOM bearings. In addition, collaborative studies have shown that the protein films are highly mobile and stream across the main-wear zones. Thus there is both an interaction with the CoCr surfaces and a degradation phenomenon that likely results in the protein-rich layers in the transition regions.

Figure 1: SEM images of type 1 and type 2 protein films.

Figure 2: Protein films on MOM bearings under three different protein concentrations.

Is is believed that 3rd-body wear of polyethylene, be it from particles of bone, bone-cement (PMMA), or metal, is an unavoidable risk in total hip arthroplasty (THA). Simulator studies have demonstrated that wear in conventional polyethylene (CXPE) and highly crosslinked polyethylene (HXPE) cups increased 6 and 20-fold respectively when challenged by circulating 3^rd-body PMMA particulates. There was no corresponding change in head roughness, i.e. the PMMA did not roughen CoCr surfaces. Many contemporary cup designs now use the vitamin-E process combined with higher crosslinking dosage (VEPE). However, little if anything is known about the VEPE debris. Therefore in this study we analyzed the morphology of VEPE particles from cups that had been run in, a) standard simulator test mode and b) adverse PMMA debris-challenge mode. The aim of this study was to determine how a clinically relevant challenge, such as addition of PMMA particles affected the wear debris. This had not been attempted previously due to contamination polyethylene by PMMA debris. The hypotheses were that, a) during the ‘clean’ test, VEPE would yield smaller debris of standard globular shape compared to controls (XPE) and b) in adverse PMMA challenge mode, VEPE debris size would increase and become more flake-like.

The XPE and vitamin-E blended cups (VEPE) cups were gamma-irradiated at 7.5 Mrad and 15 Mrad, respectively. Cups were run Inverted and mated with ceramic femoral heads of diameter 44 mm (Biolox-delta, Ceramtec). The three test phases included; ‘clean’ for 6 million cycles (6 Mc), abrasive slurry 6–8 Mc (concentration 10g/L), and ‘clean’ 8–10 Mc. The debris was isolated using standard procedure for ‘clean’ tests and a modified procedure for the abrasive slurries. Particles were imaged using SEM and the micrographs analyzed (Image J). Approximately 600 particles were analyzed from each sample (4.5 Mc and 8 Mc) and morphology defined via aspect ratio (AR), equivalent circular diameter (ECD), and circular shape factor (CSF).

The clean test revealed slight differences in shape factors for XPE and VEPE (AR, CSF within 30%: p <0.0001) but none with regard to size (p > 0.9999). The median ECD for both XPE and VEPE was approximately 0.55 μm. The abrasive test revealed a statistical difference (p < 0.0001) in shape compared to the clean test, but varied less than 25%. The greater change in debris morphology between the abrasive test and clean test was size, which increased 3.6 fold for VEPE particles (ECD = 2.0 μm) and 4.3 fold for XPE particles (ECD = 2.3 μm).

It was determined that addition of vitamin E to the PE did not change the size, but did change the shape of PE debris particles up to 30%. This study was the first to isolate debris particles during an abrasive slurry test and determine morphology under such conditions. Debris particles formed in abrasive conditions were found to be 4-fold larger in diameter, suggesting a larger volume of shreds in comparison to the mostly submicron population observed under standard testing conditions.

Figure 1: Boxplot of equivalent circular diameter values.

Figure 2: Boxplot of aspect ratio values.

Figure 3: Boxplot of circular shape factor values.

This study of retrieved 28 mm Metasul™ (cemented) revealed for the first time adverse wear effects created by impingement-subluxation in MOM. The 10 cases selected (with femoral stems) had annual follow-up 3–11 years. (1) Unequivocal evidence here shows that all heads routinely subluxed from the Metasul liners.

Femoral stems revealed well-demarcated notches (DN) on necks and trunnions (Fig. 1a: n = 6), shallow cosmetic blemishes (Fig. 1b CB: n = 4), and abrasion by cement (Fig. 1b: PMMA). As demonstrated by EOS radiographs, impingement locations varied with implant positioning, pelvic mobility and patient functionality – both anterior and posterior notching (Fig. 1). The first impingement notch occurred with head located (Fig. 2a), whereas the head had subluxed from the cup at 2^nd notch (Fig. 2b). The model demonstrated that patients gained 20° motion by such head-subluxation manoeuvres. It was surprising that there was no collateral damage evident on the liners. Even with severe notching of Ti6Al4V and CoCr stems, the cup rims generally appeared well-polished.

Femoral heads revealed macro-stripe damage on articular surfaces (Fig. 3), as did cups. Basal and polar macro-stripes on heads were always located at hip impingement positions. The equatorial stripes were formed at main-wear zone boundaries. Thus equatorial stripes were likely created by some form of rim-impact damage (micro-separation) or by local ingress of 3^rd-body wear particles under the cup rim.

Micro-grooving was evident within these macro-size stripes and frequently featured large raised lips (Fig. 3), interpreted as signs of adverse 3^rd-body wear mechanisms, and rarely described.(2) It would appear that large metal particulates were released during MOM impingement-subluxation manoeuvres and circulated the hip joint to producing severe 3^rd-body abrasion. Gradual decomposition of such large debris to nano-sized particulates under joint loading would then produce the often-referenced ‘self polishing’ effect of CoCr. EDS studies revealed metal smears on the CoCr surfaces containing the elements of titanium alloy (Ti, Al, V). This was further evidence of impingement-subluxation manoeuvres.(1, 3)

In-vivo cup wear patterns also appeared much larger than those produced in MOM simulators. Such differences likely reflected head-subluxation in vivo, whereby heads unconstrained by the subluxation maneuver were free to orbit up and even cross cup rims, i.e. “edge wear”. This appears to be the first study detailing the adverse wear mechanisms in MOM bearings. There are two limitations to our retrieval study, a) these wear results may not be representative for all MOM designs, and b) it is unknown whether such results have relevance to MOM cases continuing successfully.

Damage to metal-on-metal bearings (MOM) has been varyingly described as “edge wear,” third-body abrasive wear and “rim-damage” (1–4). However, no distinction has been made between any of these proposed wear mechanisms. The goal of this study was to discover what features might differentiate between surface damage created by either 2-body or 3-body wear mechanisms in MOM bearings. The hypotheses were that surface damage created by impingement of the cup rim (2-body wear) would be i) linear on the micro-scale, ii) reveal transverse striations (in direction of the sliding rim), iii) have either no raised lip or have a single lip along one side of the track, and iv) have an asymmetrical surface profile across the track width.

Five cases with 28 mm MOM, five of 34–38 mm MOM, and five of 50–56 mm diameter were studied (N = 15). The main wear zone (MWZ) was measured in each MOM head and the number of 2-body wear tracks recorded in the non-wear (NWZ) and main wear zone (MWZ). Bearing damage was examined using a white-light interferometer (Zygo Newview 600; 5x lens) and a scanning electron microscope (Zeiss MA15). The depths and slopes were assessed across the width of the damage tracks.

Thirteen of the 15 MOM bearings showed wear tracks that exhibited all four of the hypothesized 2-body wear characteristics. These wear tracks will be referred to as “micro-segments”. While micro-segments visually appeared linear, microscopically they revealed a semi-lunar edge coupled with transverse striations leading to a linear edge. This indicated that during impingement episodes, the cup rim ploughed material from the CoCr surface at the semi-lunar edge (Fig. 1), thereby creating the abruptly raised lip on the linear edge of the track. This “snow plough effect” and its distinct edge effect can account for the asymmetrical surface profile. A different type of 2-body wear was identified and referred to as “furrows”. Furrows also visually appeared linear visually, but microscopically revealed longitudinal striations and a symmetrical surface profile (Fig. 2). Furrows had lips raised on both sides of the track, but not circumscribing the terminal ends of the track. Instead, the ends of the furrows are tapered smooth transitions to the articular surface.

Thus, 2-body tracks were found to be distinguishable from 3-body tracks (micro-grooves) and were classified as either micro-segments or furrows. Micro-segements supported hypotheses 1–3 and provided a clearer definition for hypothesis-4, while furrows only supported hypothesis 1. The divergence in features between micro-segments and furrows allude to different interactions between the bearing and cup rim that led to each type of track. While these data represent a small set of cases (n = 15) this evidence shows for the first time what was previously only suspected (2), that the CoCr rim can routinely create 2-body wear damage mechanisms in MOM femoral heads.

Controversy exists over the role of fretting-corrosion in modular junctions of large-diameter metal-on-metal (MOM) heads given the many design plus alloy mix-and-match variations. Overall data was also scant regarding a) fitting stem trunnions to head tapers, b) role of taper angles, c) role of smooth vs threaded trunnion junctions, d) role of head neck-lengths and e) role of head diameters. While the “12: 14” taper has been used with small CoCr heads for 40 years, we could not find retrieval analyses on this European ‘gold-standard’. We therefore selected 10 femoral stems with 28 mm modular heads for analysis (3–8 years follow-up). Unique to this study were the threaded taper profiles on both stems and heads (Fig. 1).

Six stems were cemented Ti6Al4V (Alize, FH-Orthopedics, France) with 12/14 taper angle defined as 5° 42′. These represented Ti64: CoCr combinations from 2 vendors. The other four were CoCr stems including the CoCrMo (Protasul-2) and CoNiCrMo (Protasul-10) alloys (cemented and HA-coated; Sulzer, Switzerland). These CoCr: CoCr combinations from one vendor had “12/14” stem-taper defined as 5° 38′. Anatomical positioning of Metasul heads (Sulzer, Switzerland) was identified by main-wear zone maps. Femoral heads were then bi-valved in horizontal plane for direct imaging by interferometry (WLI) and SEM. Visual corrosion mapping (3) was recorded digitally in 4 anatomical views. Quantitative analysis used 1 to 5 taper zones with 6-replicate measurements per zone (Fig. 1).

The WLI and SEM studies showed that non-contacting taper zones inside CoCr heads (Fig. 2) were threaded with pitch of 70 μm (PV: peak-valley depth = 5–7 μm). The non-contact zones on Sulzer stems had 130 μm pitch (PV = 4–8 μm) whereas Alize stems had 210 μm pitch (PV = 10–12 μm). Threads on both stem types were much coarser than CoCr heads; Ti64 stem threads were much coarser than CoCr stems. In contact zones, the Metasul threads had flattened (avg. roughness = 0.45 μm Ra). With CoCr stems there was little difference. Difference in pitch of stem-threads vs head-threads indicated there was no imprinting onto head tapers. Nor were there statistically significant differences evident in the contact zones along CoCr or Ti64 tapers. Small damaged areas (Fig. 3: arrows) may have been due to alternatively; initial machining, surgical impaction, in-vivo cold-welds, fretting, corrosion, or from surgical-removal. The as labeled “corrosion damage” was well within the “mild” grade for all implants.(3) Thus even with this considerable variety of design and material parameters, we were satisfied that these gold-standard taper junctions with threaded interfaces had performed very well with 28 mm MOM at 3–8 years follow-up.

Controversy has existed for decades over the role of fretting-corrosion in modular CoCr heads used with stems of CoCr vs Ti6Al4V. Since retrieval data on taper performance remains scant, we report here an18-year survivorship of a Ti6Al4V: CoCr combination (APR design; Intermedics Inc). Unique to this study were the threaded profiles present on both stem and head tapers (Fig. 1).

This female patient was revised for pain, osteolysis and recurrent hip dislocation at 17 years, 10 months. A prior MPE hip replacement performed for her severely dysplastic right hip had lasted 11 years. At this 2nd revision, the 28 mm CoCr head was found dislocated posteriorly and superiorly. Metallosis was evident in the tissues. The polyethylene liner showed extensive rim damage on both anterior and posterior aspects. The neck of her APR Revision stem (Intermedics Inc) had worn through the polyethylene rim and impinged on the metal cage. The cage was found loose, the liner had disassociated, and the peri-trochanteric areas were compromised by massive osteolysis. The femoral stem and head were removed together without disassembly. The femoral stem and acetabular construct were replaced by an ARCOS revision system using 36 mm head with a Freedom cup (cemented to Max-Ti cage; Biomet Inc.).

The complete femoral neck and head were bi-valved assembled in horizontal plane for direct imaging by interferometry and SEM (Fig. 1a). After sectioning the head separated from the stem. Quantitative imaging used 1 to 5 regions with 6-replicate measurements per region and differentiation into contact and non-contact zones (Fig. 1b). Visual corrosion mapping (3) was recorded digitally in 4 anatomical views (Figs 1b–f).

The thread profile on contact zone inside the head (Fig. 2a) had a pitch of approximately 40 μm and a peak-to-valley depth of 4 μm overall (Fig. 2b profile section of thread: PV = 2 μm). The thread profile on stem trunnion (Fig. 3a) had a pitch of approximately 125 μm and a peak-to-valley depth of 3.5 μm overall (Fig. 2b profile section of thread: PV = 1 μm). Thus the stem trunnion thread was much coarser than the head. Overall corrosion grading was judged very mild. Overall we were satisfied that this Ti6Al4V: CoCr combination taper junction with threaded interfaces had performed very well for 18 years. Nevertheless, our visual grading was subject to opinion and thus unrewarding. The continuing project will quantify the contacting and non-contacting regions of head and stem (Fig. 1b).

It has come to light that one significant mechanism for MOM failure may be repeated subluxation or impingement episodes leading to edge wear and release of 3^rd body particles. This MOM debris-challenge model simulates a patient who experienced one subluxation or impingement event and then continues to walk normally until the next event occurs one week later. Our model assumes that 100–200 particles (debris size 100–200 μm) would be released into the joint space at each subluxation or impingement event. The question then becomes: what is the effect of the patient walking on that single dose of particulates over the next week (or 500,000 cycles in simulator test mode).

Nine 38 mm CoCrMo bearings (DJO Inc., Texas) were run inverted in a12-station hip simulator (SWM, Monrovia, CA). The test was run in standard simulator mode (Paul gait load cycle: 0.2–2 kN, frequency 1 Hz) with the addition of 5 mg of debris particles for the first 3 Mc, followed by 10 mg of debris particles from 3–5 Mc. Commercially available CoCr (ASTM F75) and titanium alloy (ASTM F136) particles and broken polymerized bone cement particles were used in the size range 50–200 μm. Serum was changed out every 500,000 cycles and a fresh dose of debris added. All bearings were ultrasonically cleaned and examined using white light interferometry (WLI, Zygo Corp) and SEM (EVO MA15, Zeiss). Wear rates were determined gravimetrically and serum discoloration was noted at each test interval.

Titanium alloy and CoCr debris produced darkened serum within the first hour of the test and remained so for the duration (500,000 cycles). Serum color with cement debris remained an opaque golden color throughout the test run. The debris challenge provoked the largest MOM wear response using Ti6Al4V particulates (6.7 mm³/Mc), slightly milder with CoCr particulates (4.5 mm³/Mc) and minimal with PMMA particulates (0.5 mm³/Mc). Compared to bone cement debris chambers (which had wear rates comparable to non abrasive MOM bearing tests), CoCr debris created a 9-fold higher MOM wear and titanium alloy debris created a 14-fold higher MOM wear. These observations indicated that only the metal debris elicited an ‘Adverse’ wear response with MOM bearings.

There is a consensus that impingement, subluxation, and dislocation are major risks that can lead to failure in total hip arthroplasty (1). As well as producing edge-wear, such clinical events also may create additional loads of particulate debris (2). It has been suggested that the release of metal debris with collateral damage on metal-on-metal (MOM) bearings creates a particularly severe abrasive wear, hitherto not understood, and recently termed ‘micro-grooving’ (3,4). Perhaps related to this micro-grooving, large surface depressions have also been observed. These we labeled ‘Dongas’, from the South African term for a steep-sided gully created by erosion. The goal of this study was to examine Dongas found on retrieved MOM bearings and to correlate factors such as cause of revision, MOM diameter and Donga locations with respect to regions of normal and stripe wear. Our hypotheses were: (1) Dongas will be most visible in non-wear zones (NWZ) adjacent to the main-wear zone boundary (MWZ), (2) the 28 mm MOM, being inherently less stable compared to large-diameter MOM, will show a higher Donga frequency and (3) patients with subluxation or dislocation complaints will reveal a higher Donga frequency.

Five cases with 28 mm MOM, five of 34–38 mm, and five of 50–56 mm diameter were studied (N = 15). The MWZ was measured in each MOM head and the number of NWZ and MWZ Dongas recorded. Bearing damage was examined using a white-light interferometer (Zygo; 5x lens).

Dongas were mainly elliptical in shape, but sometimes highly irregular. They were commonly circumscribed by raised lips (Fig. 1). Donga “trails” were also found, appearing as a linear series of similar-sized Dongas (Fig. 2). Donga trails exhibited some variability with raised lips either lining only the opposite sides or circumscribing most of the perimeter. The Dongas were commonly found in NWZ, with less than 20% found in MWZ. For this set of 15 MOM bearings, large-diameter bearings showed the largest number of Dongas and the greatest frequency of Dongas resulted from either loose or migrating cups.

The high occurrence of dongas in the non-wear zone (supporting hypothesis-1) may be a result of particles swept into the bearing interface (2,5). The size of the Dongas and their frequent association to local micro-grooves indicated that these were the impact sites of circulating particles. Such large surface depressions (40–200 μm) have not been described previously and may be unique to MOM bearings (3,4). The observation that Dongas were most prevalent in cases with loose or migrating cups left hypothesis-2 unsatisfied. The much higher incidence of Dongas in the large-diameter MOM was surprising and negated hypothesis-3. Overall these new data relating Dongas and micro-grooves gives new credence to a hitherto unsuspected 3^rd-body abrasive wear mechanism due to repetitive subluxation or impingement.

The MOM controversy continues with many prevailing opinions as to the causes of failure in contemporary designs. There has been a great deal of focus on breakdown in fluid-film lubrication with respect to cup positioning and edge wear at its rim. However there has been very little discussion on the problems of 3^rd body abrasion. In only one study was there a description of unusually large abrasive marks on retrieved femoral heads (McKee Farrar MOM), revealing 100 μm wide scratches, attributed to circulating particles fractured during impingement episodes. With contemporary MOM devices, there is the potential for abrasion by particulates of CoCr, PMMA and Ti6Al4V. However it has been difficult to formulate a coherent simulator model for 3^rd-body abrasive wear, given the unpredictable nature of impingement damage releasing abrasive particles into the patient's hip joint. Thus this study sought to identify if metal or cement particulates were capable of creating 100 μm wide scratches as seen on retrieved MOM and develop a simulator model for 3^rd body abrasive testing on MOM bearings.

Six 38 mm CoCrMo bearings (DJO Inc., Texas) were run in a12-station hip simulator (SWM, Monrovia, CA) with cups mounted both anatomically and inverted (3 MOM each). The tests were run in standard simulator mode (Paul gait load cycle: 0.2–2 kN, frequency 1 Hz) with the addition of 5 mg of debris particles. Commercially available CoCr (ASTM F75) and titanium alloy (ASTM F136) particles and broken polymerized bone cement particles were used in the size range 50–200 μm. The simulator was run for only 10 cycles and the MOM parts removed for study. All bearings were ultrasonically cleaned and heads were examined using white light interferometry (WLI, Zygo Corp). Grooves were characterized using surface profiles to measure width, depth, and rim height. SEM imaging (EVO MA15, Zeiss) and EDS imaging (X flash detector 4010, Bruker AXS) was performed in areas of grooving and suspected transfer layers.

CoCr debris produced broad, curvilinear grooves with widths ranging from 20–170 μm, depths from 0.3–1.5 μm, raised rims, longitudinal striations and chatter marks. Titanium alloy debris produced arrays of very shallow scratches accompanying larger grooves. These larger grooves measured 20–110 μm wide and 0.4–1.9 μm deep.

EDS imaging showed the smears and islands contained the elements Ti, Al and V representative of the Ti6Al4V alloy. WLI imaging showed these metal deposits (250–900 um wide) were raised >10 um above the surface. Particularly conspicuous was evidence of considerable smearing on CoCr surfaces, with linear streaks ranging 150–300 μm wide. Bone cement debris proved incapable of grooving the CoCr surface, the only scratches observed were those comparable to normal carbide scratches.

The purpose of this study was to determine the survivorship for a single MOM implant series and create an affordable clinical follow-up model. A retrospective cohort of 104 primary MOM THA procedures (94 patients) were all performed by one surgeon at three local hospitals and have reached 7–12 years follow-up. Fifteen patients are now deceased and 16 patients have been lost to follow-up. In the remaining 63 patients, 8 are bilateral providing a total of 71 THA for study. The clinical follow-up model included: hip score, X-rays, ultrasound, and metal ion testing. Due to the diversity of patient location, a variety of clinical labs were utilized for metal ion analysis. Statistical methods included a Kaplan-Meier survival curve. Hip scores were available for all 71 THA and of these 61 had a hip score (HHS) above 80 (86%). Fifty-three X-rays were available and of these 42 (79%) were in the safe zone (inclination ≤55 and anteversion ≤35). Thirty-six ultrasounds were performed and of these two yielded fluid collections (6%). Metal ion concentrations in either whole blood or serum have been documented for 32 of 63 patients (51%). Three outliers were identified within the metal ion concentrations; Co ranged 0.3–71.1 ppb (average 7.9, median 3.6), Cr ranged 0–26.9 ppb (average 4, median 2.1) and Ti ranged 2–100 ppb (average 51.8, median 52). Three patients have been revised by the original surgeon and two patients are currently scheduled to undergo revision surgery. Of the three patients revised, only one had a documented wear problem resulting from anterior subluxation, while the other two were revised for femur fracture and infection. These results represent survivorship of 94.7% at 9 years and may be a result of anterior lateral approach performed by one surgeon in which 79% of cups were well placed.