This study reports the mid-term results of a large bearing hybrid metal on metal total hip replacement (MOMHTHR) in 199 hips (185 patients) with mean follow up of 62 months. Clinical, radiological outcome, metal ion levels and retrieval analysis were performed. Seventeen patients (8.6%) had undergone revision, and a further fourteen are awaiting surgery (defined in combination as failures). Twenty one (68%) failures were females. All revisions and ten (71%) of those awaiting revision were symptomatic. Twenty four failures (86%) showed progressive radiological changes. Fourteen revision cases showed evidence of adverse reactions to metal debris (ARMD). The failure cohort had significantly higher whole blood cobalt ion levels (p=0.001), but no significant difference in cup size (p=0.77), inclination (p=0.38) or cup version (p=0.12) in comparison to the non revised cohort. Female gender was associated with an increased risk of failure (chi squared p=0.04). Multifactorial analysis demonstrated isolated raised Co levels in the absence of either symptoms or XR changes was not predictive of failure (p=0.675). However both the presence of pain (p<0.001) and XR changes (p<0.001) in isolation were both significant predictors of failure. Wear analysis (n=5) demonstrated increased wear at the trunnion/head interface (mean out of roundness measurements of 34.5 microns +/−13.3 (+/−2SD, normal range 8-10 microns) with normal levels of wear at the articulating surfaces. There was evidence of corrosion at the proximal and distal stem surfaces. The cumulative survival rate, with revision for any reason was 92.4% (95%CI: 87.4-95.4) at 5 years. Including those awaiting surgery, the revision rate would be 15.1% with cumulative survival at 5 years of 89.6% (95% CI: 83.9-93.4). This MOMHTHR series has demonstrated unacceptable high failure rates with evidence of high wear at the head/trunnion interface and passive corrosion to the stem surface. This raises concern with the use of large heads on conventional 12/14 tapers. Female gender was an independent risk factor of failure. Metal ion levels remain a useful aspect of the investigation work up but in isolation are not predictive of failure.
Metal-on-metal hip resurfacing prostheses are a relatively recent intervention for relieving the symptoms of common musculoskeletal diseases such as osteoarthritis. While some short term clinical studies have offered positive results, in a minority of cases there is a recognised issue of femoral fracture, which commonly occurs in the first few months following the operation. This problem has been explained by a surgeon's learning curve and notching of the femur but, to date, studies of explanted early fracture components have been limited. Tribological analysis was carried out on fourteen retrieved femoral components of which twelve were revised after femoral fracture and two for avascular necrosis (AVN). Eight samples were Durom (Zimmer, Indiana, USA) devices and six were Articular Surface Replacements (ASR, DePuy, Leeds, United Kingdom). One AVN retrieval was a Durom, the other an ASR. The mean time to fracture was 3.4 months. The AVNs were retrieved after 16 months (Durom) and 38 months (ASR). Volumetric wear rates were determined using a Mitutoyo Legex 322 co-ordinate measuring machine (scanning accuracy within 1 micron) and a bespoke computer program. The method was validated against gravimetric calculations for volumetric wear using a sample femoral head that was artificially worn in vitro. At 5mm3, 10mm3, and 15mm3 of material removal, the method was accurate to within 0.5mm3. Surface roughness data was collected using a Zygo NewView500 interferometer (resolution 1nm). Mean wear rates of 17.74mm3/year were measured from the fracture components. Wear rates for the AVN retrievals were 0.43mm3/year and 3.45mm3/year. Mean roughness values of the fracture retrievals (PV = 0.754nm, RMS = 0.027nm) were similar to the AVNs (PV = 0.621nm, RMS = 0.030nm), though the AVNs had been in vivo for significantly longer. Theoretical lubrication calculations were carried out which found that in both AVN retrievals and in seven of the twelve cases of femoral fracture the roughening was sufficient to change the lubrication regime from fluid film to mixed. Three of these surfaces were bordering on the boundary lubrication regime. The results show that even before the femoral fracture, wear rates and roughness values were high and the implants were performing poorly.
Wear debris induced osteolysis is a recognized complication in conventional metal-on-polyethylene hip arthroplasty. One method of achieving wear reduction is through the use of metal-on-metal articulations. One of the latest manifestations of this biomaterial combination is in designs of hip resurfacing which are aimed at younger, more active patients. But, do these metal-on-metal hip resurfacings show low wear when implanted into patients? Using a Mitutoyo Legex 322 co-ordinate measuring machine (scanning accuracy less than 1 micron) and a bespoke computer program, volumetric wear measurements for retrieved Articular Surface Replacements (ASR, DePuy) metal-on-metal hip resurfacings were undertaken. Measurements were validated against gravimetric calculations for volumetric wear using a sample femoral head that was artificially worn in vitro. At 5mm3, 10mm3, and 15mm3 of material removal, the method was shown to be accurate to within 0.5mm3. Thirty-two femoral heads and twenty-two acetabular cups were measured. Acetabular cups exhibited mean volumetric wear of 29.00mm3 (range 1.35 - 109.72mm3) and a wear rate of 11.02mm3/year (range 0.30 - 63.59mm3/year). Femoral heads exhibited mean wear of 22.41mm3 (range 0.72 - 134.22mm3) and a wear rate of 8.72mm3/year (range 0.21 - 31.91mm3/year). In the 22 cases where both head and cup from the same prosthesis were available, mean total wear rates of 21.66mm3/year (range 0.51 - 95.50mm3/year) were observed. Revision was necessitated by one of five effects; early femoral neck fracture (4 heads), avascular necrosis (AVN) (2 heads, 1 cup), infection (1 head, 1 cup), adverse reaction to metal debris (ARMD) (19 heads, 18 cups) or ARMD fracture (6 heads, 2 cups). Mean paired wear rates for the AVN and infection retrievals were 0.51mm3/year and 3.98mm3/year respectively. In vitro tests typically offer wear rates for metal-on-metal devices in the region of 2-4mm3. Mean paired wear rates for ARMD and ARMD fracture were 17.64mm3/year and 68.5mm3/year respectively, significantly greater than those expected from in vitro tests. In the 4 cases of early fracture, only the heads were revised so a combined wear rate calculation was not possible. The heads exhibited mean wear rate of 8.26mm3/year. These high wear rates are of concern.
Bearing diameter and acetabular component orientation have been shown to be important variables effecting blood metal ion levels following hip resurfacing arthroplasty. So far no studies on bilateral hip resurfacings have taken into account these variables. We examined the serum ion results of patients under the care of two experienced hip resurfacing surgeons who carry out ion analysis as part of routine post operative care. Surgeon 1: Patients were implanted exclusively with a “third generation” resurfacing device. Surgeon 2: Patients were implanted with the same “third generation” device and also a low clearance “fourth generation” resurfacing device. Only ion results from patients who were 12 months post surgery were included. Bilateral patients were matched to unilateral patients according to the surgeon performing the operation; the resurfacing system implanted and cup inclination and anteversion angles. The ion data from each bilateral group was tested against the corresponding unilateral groups using the Mann Whitney U test for non parametric data. Significance was drawn at p<0.05. Surgeon 1: There were 310 patients with unilateral joints and 50 with bilateral joints. There were no significant differences with regard to time to follow up, activity levels, joint sizes or cup orientations. Serum chromium (Cr) and cobalt (Co) concentrations were significantly greater in the bilateral group (p<0.001). Median ion levels were greater in the bilateral group by a factor of >2 in the smallest joint sizes and <2 in the largest joints. Surgeon 2: There were 11 patients with bilateral third generation resurfacing joints and 50 with unilateral joints of the same design. The same relationship as described above was identified. There was a notable difference in the fourth generation implant group (n=13 bilateral, n=100 unilateral). Median ion levels for patients receiving bilateral joints of sizes <47mm were ten times greater than in the corresponding unilateral group. Bearing diameter and component design are critical factors in determining metal ion levels following bilateral hip resurfacings. Surgeons must consider the potential implications of gross increases in metal ion levels prior to performing bilateral hip resurfacings in smaller patients.
Cup orientation in vivo was compared to explant analysis of 60 retrieved resurfacing components using a coordinate measuring machine.
In our independent centre, from 2002 to 2009, 155 BHRs (mean F/U 60 months) have been implanted as well as 420 ASR resurfacings and 75 THRs using ASR XL heads on SROM stems (mean F/U 35) During this period we have experienced a number of failures with patients complaining of worsening groin pain at varying lengths of time post operatively. Aspiration of the hip joints yielded a large sterile effusion on each occasion. At revision, there were copious amounts of green grey fluid with varying degrees of necrosis. There were 17 failures of this nature in patients with ASR implants (12 females) and 0 in the BHR group. This amounts to a failure of 3.5% in the ASR group. Tissue specimens from revision surgery showed varying degrees of “ALVAL” as well as consistently high numbers of histiocytes. Particulate metal debris was also a common finding. The mean femoral size and acetabular anteversion and inclination angles of the ARMeD group/all asymptomatic patients was 45/49mm (p<
0.001), 27/20°(p<
0.001) and 53/48°(p<
0.08). Median blood chromium(Cr) and cobalt(Co) was 29 and 69 μg/L respectively in the ARMeD group versus 3.9 and 2.7 μg/L in the asymptomatic patients (n=160 with ion levels). Explant analysis confirmed greater rates of wear than expected. Lymphocyte proliferation studies involving ARMeD patients showed no hyper reactivity to Cr and Co in vitro implying that these adverse clinical developments are mediated by a toxic reaction or a localised immune response. Our overall results suggest that the reduced arc of cover of the fourth generation ASR cup has led to an increased failure rate secondary to the increased generation of metal debris. This failure rate is 7% in ASR devices with femoral components _47mm.
For the whole cohort, there was no significant difference in ion levels (Cr: p=0.092. Co=0.075) between cups positioned within Z3 (n=58) versus those outside (n=46 mean). Male patients with cups within Z3 (n=27) had lower ion levels in comparison to those outside Z3, which were significantly lower for Co (p=0.049) but not Cr (p=0.084). Female patients had similar levels within and out of Z3 for both ions (Cr: p=0.83, Co: p=0.84). However, patients with cups within Z1 (n=13) had significantly lower Co (p=0.005) and Cr (p=0.001) than those outside Z1 (n=95). Interestingly, Co levels were significantly lower in Z1 (n=13) in comparison to Z2 (n=33) (p=0.048) but Cr levels were not different (p=0.06).
This report documents the clinical and histological findings, the operative management and the explant analyses of patients with early aseptic failure of large metal-on-metal (MonM) bearing joints. Three hundred and fifty patients have been implanted with the ASR bearing surface (resurfacing or a modular THR) by a single surgeon at an independent centre since 2004. Six patients (all female) have been revised secondary to aseptic failure. All complained of severe groin pain exacerbated by straight leg raise and routine investigations were unable to establish a cause. Large amounts of sterile, highly viscous green fluid were aspirated from the hip joints in each case. Gross swelling of the pseudocapsule and a similar green fluid surrounding the implants were found at revision surgery. Histological examination of periprosthetic tissue samples showed changes consistent with ALVAL/metallosis, and analysis of the fluid revealed dense numbers of inflammatory cells. Symptoms in patients revised to ceramic-on-ceramic bearings improved post operatively. This was not the case with those reimplanted with MoM joints. Data from a subset of 76 patients (all unilateral resurfacings) showed that malaligned cups (anteverted >
20° +/− inclination angle >
45°) were associated with significantly higher whole blood metal ion levels than cups positioned within this range. All the patients with early aseptic failure had malaligned cups. Independent explant analysis revealed significant increases in the surface roughness values of the articular surfaces. Our results suggest that some patients develop a significant inflammatory reaction to metal implants. This may be due to high levels of metal debris around the implant as a result of accelerated wear. Poor component alignment was found in all our patients with early aseptic failure.
Metal ion concentrations following metal on metal hip resurfacing arthroplasty remain a concern. Variables associated with increased metal ion concentrations need to be established. This study provides metal ion data from a consecutive cohort of the first 76 patients implanted with a fourth generation hip resurfacing prosthesis. All patients agreed to post-operative blood metal ion sampling at a minimum of one year. Post-operative radiographic measurements of cup inclination and anteversion were obtained using the EBRA software. Mean whole blood chromium (Cr) and cobalt (Co) concentrations in patients receiving the smallest femoral implants (Ł51mm) were greater than in the patients implanted with the largest prostheses (ł53mm) by a factor of 3 and 9 respectively. Ion concentrations in the small femoral group were significantly related to acetabular inclination (R=0.439, P<
0.001 for Cr, R=0.372, P=0.004 for Co) and anteversion (R=0.330, P=0.010 for Cr, R=0.338, P=0.008 for Co). This relationship was not significant in the large implant group. Mean Cr and Co concentrations in patients with accurately orientated cups (inclination <
45°, anteversion <
20°) were 3.7μg/l and 1.8 μg/l respectively, compared to 9.1μg/l and 17.5μg/l in malaligned cups. A reduced surface contact area caused by cup malalignment may increase contact stresses, resulting in a high wear rate if fluid film lubrication is inadequate. Improved fluid film lubrication has previously been found in larger heads in vitro. Accurate acetabular component positioning is essential in order to reduce metal ion concentrations following hip resurfacing.
Five blinded orthopaedic registrars then used EBRA (Einzel-Bild-Roentgen-Analysis, University of Inns-bruck, Austria) software to determine the radiological anteversion from the AP films. Twenty-five ASR and twenty-five BHR images were analysed. At the same time each observer was asked to grade the cups as “1” (<
10°) “2” (10–20°) “3” (20–30°) or “4” (>
30°) depending on the appearances of the cup vertices.
Cups graded as “1” or “4” showed high sensitivity and specificity for the true grade as determined on the lateral radiographs.
In our independent centre, in the period from January 2003 to august 2008, over 1100 36mm MoM THRs have been implanted as well as 155 Birmingham Hip Resurfacing procedures, 402 ASR resurfacings and 75 THRs using ASR XL heads on SROM stems. During this period we have experienced a number of failures with patients complaining of worsening groin pain at varying lengths of time post operatively. Aspiration of the hip joints yielded a large sterile effusion on each occasion. At revision, there were copious amounts of green grey fluid with varying degrees of necrosis. There were 11 failures of this nature in patients with ASR implants (10 females) and 2 in the 36 MoM THR group (one male one female). Tissue specimens from revision surgery showed varying degrees of ‘ALVAL’ as well as consistently high numbers of histiocytes. Metal debris was also a common finding. A fuller examination of our ASR cohort as a whole has shown that smaller components placed with inclinations >
45° and anteversions <
10 or >
20° are associated with increased metal ion levels. The 11 ASR failed joints were all sub optimally positioned (by the above definition), small components. Explant analysis using a coordinate measuring machine and out of roundness device confirmed greater than expected wear of each component. The lower number of failures in the 36mm MoM group, as well as the equal sex incidence, suggests that the majority of these failures are due to the instigation of an immune reaction by large amounts of wear debris rather than adverse reactions to well functioning joints. It is likely that small malpositioned ASRs function in mixed to boundary lubrication, and this, combined with the larger radius of these joints compared to the 36mm MoM joints, results in more rapid wear.
Optimal cup orientation for metal-on-metal hip resurfacing has yet to be established. Guidance is based on hip replacement data and in vitro studies. We sought to determine the influence of component size and positioning on early clinical outcome. This study comprises a consecutive series of 200 hip resurfacings. All had Harris Hip Scores (HHS) at one-year review. Acetabular inclination angles were measured on pre-operative radiographs, and cup inclination/anteversion angles on 3-month post-operative films using EBRA. Restoration of anatomy was defined as placement of the cup within +/−5 degrees of pre-operative inclination. The difference between pre-operative acetabular and post-operative cup inclination was termed cup-angle difference (CAD). HHS inversely correlated with CAD (P=0.023) and anteversion (P=0.003), and directly correlated with femoral head size (P<
0.001). In patients with restoration of inclination anatomy mean HHS at one year was significantly higher at 98.7 compared with cups placed outside the normal anatomy restoration limits (93.8, P=0.003). Patients with anteversion >
20 degrees had a significantly lower HHS (P=0.010) compared with cups anteverted <
20 degrees. 96% of patients with HHS <
90 had malaligned cups (inclination over 45 degrees, anteversion over 20 degrees). Restoring pre-operative cup inclination, anteverting the cup <
20 degrees and using large femoral heads improves early clinical outcome following MonM hip resurfacing. We recommend accurate pre-operative planning and meticulous attention to intra-operative cup positioning with these results in mind.