Blood metal ion sampling can help detect poorly functioning metal-on-metal hip arthroplasties (MoMHA's) requiring revision. Little is known about the variation in these levels following bearing exchange. This study aimed to determine the changes that occur in blood and urine metal ion concentrations following MoMHA revision.

A single-centre prospective cohort study was undertaken between 2005 and 2012 of patients with failing large-diameter MoMHA's and high blood metal ions requiring revision to non-metal-on-metal articulations. All patients had normal renal function. Whole blood and urine were collected for metal ion analysis preoperatively and regularly following revision.

Twenty-three MoMHAs (21 hip resurfacings and 2 total hip arthroplasties; mean age 56.0 years and 65% female) were revised at a mean time of 7.9 years (range 2.0–14.5 years) from primary surgery. All revisions were performed by the senior author using primary total hip implants (12 ceramic-on-polyethylene bearings, 10 oxinium-on-polyethylene bearings, and 1 metal-on-polyethylene bearing implanted). Mean (range) metal ion concentrations pre-revision were: blood cobalt 13.9µg/l (1.32–74.7µg/l), blood chromium 8.9µg/l (1.29–57.3µg/l), urine cobalt 104.6µg/24 hours (4.35–747.3µg/24 hours), urine chromium 33.2µg/24 hours (4.39–235.4µg/24 hours). After revision the mean metal ion concentrations (percentage of pre-revision values) were: blood cobalt at 2 days=10.7µg/l (77%), 6 days=7.7µg/l (55%), 2 months=3.4µg/l (24%), 1 year=1.0µg/l (7%), 2 years=0.42µg/l (3%); blood chromium at 2 days=8.7µg/l (98%), 6 days=5.5µg/l (62%), 2 months=2.2µg/l (25%), 1 year=1.5µg/l (16%), 2 years=0.97µg/l (11%); urine cobalt at 2 days=31.9µg/24 hours (30%), 6 days=21.5µg/24 hours (21%), 2 months=6.1µg/24 hours (6%), 1 year=0.99µg/24 hours (1%), 2 years=0.61µg/24 hours (1%); urine chromium at 2 days=34.4µg/24 hours (103%), 6 days=15.8µg/24 hours (48%), 2 months=9.3µg/24 hours (28%), 1 year=2.8µg/24 hours (8%), 2 years=1.9µg/24 hours (6%).

Following MoM revision cobalt levels decline rapidly in an exponential pattern with a single rate of decay through the 2 year period, reaching reference levels within the first year. Chromium follows a similar pattern but starts lower and takes longer. Renal response to cobalt returns to reference level within days of revision.

The use of modular systems adds versatility to the implant system, better restoration of hip biomechanics and lower inventory to the hospital. There have been reports of high metal ions, ARMD reactions and high implant failure rates due to potential problems from taper failures. These are more common in metal-on-metal hip replacements, but are being also reported in other bearings.

Between 2001 and 2010, we performed 383 consecutive metal-on-metal (MoM) THRs through a posterior approach, using a BHR cup and Birmingham modular head with one of three different stems, all with 12/14 tapers. The earliest 104 hips employed a cemented MS30 stem (Zimmer GmbH, Winterthur, Switzerland). Subsequent 256 were Synergy and then 23 Anthology (both uncemented and both Smith and Nephew Orthopaedics, Memphis TN USA). There was no significant difference in the average age at surgery (65.4 years cemented vs 65.6 uncemented, p = 0.69), gender ratio (1.68 vs 1.89, p = 0.64), or bearing diameter (46.7 vs 46.8, p = 0.31). The earlier 203 Synergy stems were monoblock heads, while the remaining uncemented stems included a tapered sleeve in addition.

There were 3 deep infections and 11 debris-related failures (overall revision rate 4.9%). The revision rate from aseptic failures (ALTR, effusion, osteolysis or component loosening) is 2.87%. Kaplan-Meier analysis of the entire cohort showed a 10-year implant survival of 96.8% with revision for any reason as the end-point. Cemented stems had a 100% survival at 10 years and 98.6% at 12 years. The uncemented stems had a 93.8% survival at 10 years. Within the uncemented group, the monoblocks had a 5 and 10-year survival of 99.0% and 96.4% respectively while the sleeved had 98.7% (5 years) and 96.3% (7 years) and 82.5% at 8 years. Retreival analysis showed clear evidence of taper failure.

Our experience suggests taper failure leading to ALTRs and its sequelae. Others have reported ALTR type reactions in metal on polyethylene and ceramic on polyethylene bearing types as well in bearing diameters ranging from 28mm to 40mm. There is a need to improve taper design especially for use with large heads, and in high demand patients.

The natural knee allows multi-planar freedoms of rotation and translation, while retaining stability in the antero-posterior direction. It allows flexion with roll back, and medial, lateral and central rotation movements. The natural femoral condyles of the knee are spiral, therefore inducing a side to side translatory movement during flexion and extension. Incorporating all these features is vital in successful knee replacement design.

The different knee designs currently in use demonstrate different deficiencies in knee function. A study of 150 Posterior Cruciate (PCL) Retaining Total Knee Replacements [1] has shown that in 72% of knees direct impingement of the tibial insert posteriorly against the back of the femur was responsible for blocking further flexion. The mean pre-operative range of flexion was 105° and post-operative was 105.9°. For every 2mm decrease in posterior condylar offset, the maximum flexion was reduced by 12.2°.

The major disadvantage of the Posterior Stabilised (PS) Total Knee Replacement is gross anterior to posterior mid-flexion instability [2]. The Medial Rotation Total Knee Replacement is good in mid-flexion but not in high flexion where the femur slides forward on the tibia leading to impingement.

The Birmingham Knee Replacement (BKR) is a rotating platform knee design which is stable throughout the range of flexion. In high flexion, the BKR brings the femur to the back of the tibia. The BKR also has spiral femoral condyles, matching the natural kinematics of the knee. The combined static and dynamic effect is 10mm lateral translation of the femur in flexion and vice versa in extension.

Results for seventy nine BKRs (in seventy two patients) show the best Oxford Knee Score of 12 at follow up – excluding ten patients whose inferior scores were due to other pathologies. Knee flexion results show a 21° post-operative improvement in range of flexion.

On objective independent testing, maximum walking speed is slower for patients with a standard knee replacement (6.5km/h) and the loading through the replaced side does not match the normal side. Comparatively, patients with a BKR have a faster maximum walking speed of 11km/h and the loading closely matches that of the normal knee.

Studies based on the National Joint Register PROMs data [2] show that nearly thirty percent of Total Knee Replacement patients are not much better since their operation. A lot of improvement is needed in the design of knee replacements in order to achieve better function for knee replacement patients.

Objectives

To examine mortality and revision rates among patients with osteoarthritis undergoing hip arthroplasty and to compare these rates between patients undergoing cemented or uncemented procedures and to compare outcomes between men undergoing stemmed total hip replacements and Birmingham hip resurfacing.

High short-term failure rates have been observed with a number of metal-on-metal (MoM) hip designs. Most patients require follow-up with blood metal ions, whichprovide a surrogate marker of in-vivo bearing wear. Given these results are used in clinical decision making it is important values obtained within and between laboratories are reproducible.

To assess the intra-laboratory and inter-laboratory variability of blood metal ion concentrations analysed by four accredited laboratories.

Whole blood was taken from two participants in this prospective study. The study specimen was obtained from a 42 year-old female with ceramic-on-ceramic hip arthroplasty failure resulting in unintended metal-on-ceramic wear and excessively high systemic metal ion levels. The control specimen was from a 52 year-old healthy male with no metal exposure. The two specimens were serially diluted to produce a total of 25 samples with different metal ion concentrations in two different anticoagulants each. Thus 50 samples were sent blinded in duplicate (total 100) to four accredited laboratories (A, B, C, D) to independently analyse blood metal ion concentrations. Ten commercially available reference specimens spiked with different amounts of metal ions were also obtained with known blood metal ion concentrations (range for cobalt 0.15µg/l-11.30µg/l and chromium 0.80µg/l to 37.00µg/l) and analysed by the four laboratories.

The intra-laboratory coefficients of variation for repeat analysis of identical patient specimens were 7.32% (laboratory A), 4.64% (B), 7.50% (C), and 20.0% (D). The inter-laboratory variability for the analysis of all 25 samples was substantial. For the unmixed study specimen the laboratory results ranged from a cobalt of 263.7µg/l (D) to 525.1µg/l (D) and a chromium of 13.3µg/l (D) to 36.9µg/l (A). For the unmixed control specimen the laboratory results ranged from a cobalt of 0.13µg/l (B) to 0.77µg/l (D) and a chromium of 0.13µg/l (D) to 7.1µg/l (A). For one of the mixed specimens the laboratory results ranged from a cobalt of 12.50µg/l (A) to 20.47µg/l (D) and a chromium of 0.73µg/l (D) to 5.60µg/l (A). Similar inter-laboratory variation was observed for the other mixed samples. The true mean (standard deviation) of the 10 commercial samples was 4.48µg/l (4.20) for cobalt and 8.97µg/l (10.98) for chromium. This was similar to the values obtained by all four laboratories: mean (standard deviation) cobalt ranged from 3.54µg/l (3.17) in laboratory A to 4.35µg/l (4.13) in laboratory D, and chromium ranged from 7.76µg/l (9.50) in laboratory B to 9.55µg/l (9.16) in laboratory A.

When testing patient samples, large variations existed both between and within four laboratories accredited to perform analysis of blood metal ion concentrations. However, this was not the case when assessing commercially spiked samples which are regularly used to validate laboratory testing. This is of great clinical concern and could lead clinicians to either recommend unnecessary revision or delay surgery, with both having the potential to adversely affect patient outcomes. It is recommended that laboratories use patient samples to assess the accuracy and reproducibility of the analyses performed. This may also assist in explaining the variations observed in this study.

Metal-metal surface replacement (MoMSRA) is increasingly used in the young. Systemic metal ion release and its effects cause concern. Do metal ions cross the placenta in pregnant women with potential mutagenic effects? The hypothesis is that metal ions pass freely through the placenta and there is no difference in maternal and cord metal levels.

This is a controlled cross-sectional study of women with MoMSRA. (n=25, mean age 32years, implantation 60months, 3 bilateral). The control group were 24 subjects with no metallic implant and not receiving cobalt/chromium supplements, mean age 31years. No patient was known to have renal failure. Whole blood specimens were obtained before delivery/ fluid-infusion and Cord blood specimens immediately after delivery.

Cobalt and chromium were detectable in all specimens in both cohorts. In the control group, the difference between maternal and cord levels was only 5 to 7% indicating free passage. Study group cord levels were significantly lower than maternal cobalt, p<0.05 and chromium p<0.0001 thus rejecting the null hypothesis.

The differences between maternal and cord metal ions in the controls indicate that normally the placenta allows an almost free passage of metal ions. The relative levels of metal ions in the maternal and cord blood in the study group reveal that the placenta exerts a modulatory effect on metal transfer.

Kinematics of the knee change during the full range of flexion [1]. The lateral femoral condyle (LFC) rolls back progressively through the entire range of flexion. The medial femoral condyle (MFC) does not move back during the first 110 degrees, but from 110 to 160 degrees it moves back by 10mm. This dual arc makes anatomical knee design a challenging task. In medial rotation, during flexion, the MFC stays in place, but the LFC moves forward in extension and backward in flexion. In lateral rotation the LFC stays still while the MFC moves back and forward in flexion and extension. During central rotation both condyles move reciprocally. However the knee is stable against an anteriorly or posteriorly directed force. It is important that all these degrees of freedom and stability are reproduced in total knee replacement (TKR) design.

Furthermore, the two femoral condyles together form a spiral. Like the threads of a screw in a nut they allow medio-lateral translation of the femur [2] in the tibial reference frame. During flexion the knee centre moves laterally nearly 20% of the width of the tibial plateau and in extension the femur translates medially. This medio-lateral translation occurs in the natural normal knee joint. This has special significance in knee design because the natural femur (along with the trochlea) moves laterally in flexion, allowing the patella to be sited laterally, while most regular TKRs drive the patella medially. In order to test this anomaly we studied patellar maltracking in vivo and in cadavers.

In vivo tracking studies using a patellar tracker during total knee replacement demonstrated average patellar maltracking of 10mm with regular TKR designs. Experiments on 22 cadaveric limbs using loaded quadriceps mechanism and trackers on the femur, tibia and patella, showed that in the natural knee the patella tracked medially by an average of 5mm. In regular TKRs the patella tracked medially. Compared to a normal knee, the patella in these designs maltracked on average by 10mm. Spiral condyles applied to the same bone cuts in the cadavers allowed the patella tracking to return to the expected lateral position in flexion.

This has application to total knee replacement design. Unless the spiral design is incorporated in the condyles, patellar maltracking is inevitable and is likely to cause lateral knee pain and stiffness post-operatively.

The modern era of hip resurfacing was initiated over two decades ago to address the poor results of existing hip replacement devices in young patients. High failure rates have been reported with certain resurfacings. This is a 1 to 17-year review of a single surgeon series of resurfacings in patients under the age of 50 years.

Between July 1997 and June 2014, 3627 hip resurfacing arthroplasties were implanted at our Centre in 2878 patients using a posterior approach. Of these 863 patients (1063 hips, 754 in men and 309 in women) were under the age of 50 years at the time of operation. They were followed up with postal questionnaires for up to 10 years through independent Outcomes Centres initially and are currently followed up by our own Centre.

18 patients (24 hips) died 5.9 (0.02 – 11) years after surgery due to unrelated causes, including one patient (1 hip) who was revised and died 5 years after revision. Mean follow-up is 11.9 years (0.8 to 17.8 years). There were 22 revisions altogether (2.1%) at a mean of 6.2 years (0.01 to 14.6 years) including one malpositioned cup in a female patient with developmental dysplasia who dislocated post-operatively and had to be repositioned. 9 hips failed from collapse of the femoral-head and 3 hips from femoral-neck fractures, giving rise to 12 femoral failures in all. There were six deep infections and three bearing-related failures including one pseudotumour, one for osteolysis and one for unexplained pain with neither metallosis nor pseudotumour.

With revision for any reason as the end-point Kaplan-Meier survival analysis showed 98.9%, 98.6% and 97.2% implant survival at 5, 10 and 17 years. Men had better survival (99.1% and 98.1% at 10 and 17 years respectively) than women (97.3% and 95.3%).

17-year cumulative revision rates were higher in patients with a pre-operative diagnosis of dysplasia (6.1%) and AVN (7.6%) compared to all other diagnoses combined (1.5%). Patients with osteoarthritis had the best results (99.5%, 99.3%, 98.4% at 5, 10 and 17 years respectively).

Our study shows that resurfacing arthroplasty is a viable option for hip arthritis in the young with a low incidence of wear-related failures in the long-term.

Introduction

Little is known about variations in blood metal ions following bearing exchange for poorly functioning metal-on-metal hip replacements (MoMHRs). This study aimed to determine the changes that occur in blood and urine metal ion concentrations following MoMHR revision.

Introduction

Metal-metal surface replacement (MoMSRA) continues to be used in young women. Systemic metal ion release and its effects cause concern. Do metal ions crossing the placenta in pregnant women have potential mutagenic effects? The hypothesis is that metal ions pass freely through the placenta and there is no difference in maternal and cord metal levels.

Introduction

Large diameter metal-on-metal hip arthroplasty (LDMMTHA) provides benefits of reduced dislocation rates and low wear. The use of modular systems allows better restoration of hip biomechanics. There have been reports of modular LDMMTHAs with tapered sleeves generating excessively high metal ions, due to possible mismatch between the titanium stem and the cobalt-chrome sleeve and the dual Morse tapers involved. We evaluated metal ion levels in LDMMTHA patients with and without a cobalt-chrome (CoCr) tapered sleeve.

Introduction

Modern metal-on-metal bearing resurfacings have been in use for nearly two decades. Local and systemic metal ion exposure continues to cause concern. We could not find a prospective metal ion study in such patients with a 10-year follow-up. This is the first ten year prospective study of metal ion levels in blood and their release in urine following hybrid fixed metal-on-metal surface arthroplasty.

Introduction

This is a retrospective review of the incidence of deep venous thrombosis (DVT) in 679 consecutive unilateral primary hip arthroplasty procedures performed between January 2007 and December 2010 managed with no anticoagulants. Mean age at operation was 58 years. Mean BMI was 26. The prophylaxis regimen included hypotensive epidural anesthesia, compression stockings, intermittent calf compression, early mobilization and an antiplatelet agent.

Introduction

High early failure rates have been reported with certain metal-metal surface arthroplasties and good results have been reported with others. This is a minimum 10-year review of the first 1000 consecutive resurfacings including all ages and diagnoses from one centre.

Introduction

Wear and corrosion of metal-on-metal (MM) bearings releases (a) soluble metal ions which collect locally and pass into the systemic circulation and (b) insoluble particles which undergo local deposition and lymphoreticular dissemination. Debris-related failures from osteolysis, metallosis and pseudotumours warrants revision of these MM bearing devices to non-MM bearing arthroplasties with the expectation that both the systemic and local effects will be reversed with time since the source of metal ion release is removed.

The purpose of the present study is to determine (a) whether metal ion levels in blood and urine decrease after revision of a MM bearing arthroplasty to a non-MM bearing device and (b) the rate at which this decrease is effected.

Introduction

Hip simulator studies show that metal-on-metal bearing wear can be reduced by reducing the diametral clearance of the bearing. We present the six-year follow-up results of a prospective clinico-radiological and metal ion study in patients with a low clearance metal-metal surface arthroplasty. The results are compared to published results of similar design bearings with conventional clearance.

Introduction

The results of the Birmingham Hip Resurfacing (BHR) device in several series reveal that the predominant mode of failure is femoral neck fracture or femoral head collapse and that careful patient selection and precise operative technique are vital to the success of this procedure. In this report we consider the results of BHR in patients with severe arthritis secondary to femoral head AVN.

Introduction

Large diameter metal-metal total hip replacements (MM THRs) offer the advantages of low wear and low dislocation risk and are being increasingly used in high-demand patients whose bone quality rules out the possibility of a hip resurfacing. However suggests that large headed MM devices may result in greater systemic metal exposure compared to small diameter bearings. This raises fresh concerns of elevated systemic metal levels.

Introduction

Secondary osteoarthritis in a dysplastic hip is a surgical challenge. Severe leg length discrepancies and torsional deformities add to the problem of inadequate bony support available for the socket. Furthermore, many of these patients are young and wish to remain active, thereby jeopardising the long-term survival of any arthroplasty device.

For such severely dysplastic hips, the Birmingham Hip Resurfacing (BHR) device provides the option of a dysplasia component, a hydroxyapatite-coated porous uncemented socket with two lugs to engage neutralisation screws for supplementary fixation into the solid bone of the ilium more medially. The gap between the superolateral surface of the socket component and the false acetabulum is filled with impacted bone graft.

Evidence with respect to conventional hip arthroplasties suggests that device wear is related to patient activity rather than duration of usage. Activity level questionnaires appear to suggest that subjects with resurfacing arthroplasties continue to remain active after the procedure. However there is a paucity of objective evidence relating to the step rates of these patients in their daily lives and its effect on metal ions generated. The aim of this investigation is to assess

the activity levels of hip resurfacing patients as follow up progresses and

Twenty-five consecutive male patients (average age 56 years) who underwent a unilateral 50 mm diameter hip resurfacing carried out by a single surgeon (DJWM) were recruited after informed consent. Patient step activity (Step Activity Monitor, SAM, Cymatech. Seattle WA, USA) was recorded at 1, 2, and 4-year follow-up stages and at the same time patient whole blood samples were collected and analysed using High Resolution Inductively Coupled Mass Spectroscopy (HR-ICPMS).

All patients in this study had well functioning hips at the four year follow up stage. All femoral components implanted were within the desired range of neutral to 10°. The mean acetabular component inclination angle was 42° (33° – 55°). Patient overall step activity remains unchanged up to the 4-year follow-up period.

At one year follow up, the whole blood cobalt and chromium concentrations show no correlation to mean number of steps taken per day by each patient (r2=0.02).

The correlation between whole blood cobalt and chromium concentration versus a function of body weight and peak index is not significant (r2=0.11).

This study provides objective evidence of the activity rates of patients at different stages of follow-up after a MoM surface replacement arthroplasty. It should be emphasised that the walking speeds of these patients on average was significantly slower than 1 Hz, which is generally used in laboratory hip simulator studies.