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Cemented total hip arthroplasty yields reliable results in short to medium term studies, but aseptic loosening remains a problem in long-term follow up, especially in young and active patients. Aseptic loosening has been related to wear, and in order to minimize wear various alternatives to the traditional metal on polyethylene have been proposed. Both ceramic on polyethylene (COP) and metal on metal (MOM) have been shown to produce less wear than metal on polyethylene (MOP). In order to study the effect of the bearing, we have utilized identical stems and cups while comparing the different bearings. Methods and material. 396 hips were randomized to MOP, COP or MOM using a cemented triple tapered polished stem (MS-30; Sulzer Orthopedics) with a cemented polyethylene cup (Weber; Sulzer, Orthopedics) and a 28 millimeter head. For the MOP and COP articulations, a all-polyethylene cup was used with a Protasul™ metal head or a Sulox™ alumina head, whereas a polyethylene cup with metal insert was used for the MOM articulations (Weber Polyethylene Cup with Metasul™ Insert) with a Metasul™ metal head. Harris Hip Score (HHS) and radiological evaluation was performed after two, five and seven years. Ethical approval was obtained. Results. HHS was available for 338 hips after seven years. The HHS in the MOP group (116 hips) was 93.7 (SD 9.0), 93.5 in the COP group (112 hips) (SD 8.8), and 91.0 (SD 13.4) in the MOM group (110 hips). Radiographic evaluation was available for 335 hips. Radiolucencies around the stem larger than one millimeter were found in five of 115 MOP hips, seven of 111 COP hips and in seven of 110 MOM hips. Periacetabular radiolucencies identified as larger than one millimeter were found in none of the 116 MOP hips, five of the 112 COP hips and in 19 of the 110 MOM hips. Ten revisions were performed. In the MOP group there were three revisions (infection, dislocation, pain); one in the COM group (infection), and six in the MOM group (three infections, two aseptic loosening and one septic loosening). Discussion. Clinically, the three bearing types perform equally well at seven years, and there are few signs of impending failure for the stem. However, there are an alarmingly high proportion of cups showing signs of loosening. Two hips have been revised in the MOM group for aseptic loosening as opposed to none in the two other groups, which adds to the concern. The MOM articulation used in this study should be monitored closely for signs of aseptic loosening


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 224 - 224
1 Sep 2012
Ebreo D Khan A El-Meligy M Armstrong C Peter V
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INTRODUCTION. The advantages of large diameter metal on metal total hip arthroplasty (MoM THA) and hip resurfacing arthroplasty are decreased wear rate, preservation of bone stock, anatomical restoration and enhanced stability. Large amounts of metal wear particles and metal ions are released which may induce adverse reactions including local soft tissue toxicity, hypersensitivity reactions, bone loss and risk of carcinogenesis. Aseptic loosening can be the result of a peri-prosthetic osteolysis generated as a result of a biological response to particulate wear debris. No reports in the literature exist as to whether circulating levels of Chromium (Cr) and Cobalt (Co) decrease upon removal of a symptomatic large diameter MoM implant or whether levels remain high due to the effect of metal ions debris left behind in the soft tissues after revision surgery. PATIENTS AND METHODS. Between June 2006 and June 2009 we undertook 44 revision surgeries of both large head MoM THAs (femoral head diameter 38mm) and metal-on-metal hip resurfacings for suspected metallosis. Mean time from original implant to revision was 4 years, 8 months (1yr 4mo–7yr 9mo). The mean follow up evaluation was 2 years and 2 months (1yr 2mo–4 years). Blood samples were taken for whole blood Cr and serum Co according to a recognised protocol and compared with reference levels indicated by the Medicines and Healthcare Regulatory Agency recommendation of less than 7ppb for Cr (130nM/L) and Co (119nM/L). RESULTS. 42 patients were found to have histological evidence of either metal allergy, metal toxicity or foreign body reaction. 2 patients had evidence of infection with no features of metal reaction. 3 patients suffered early dislocation requiring closed reduction. 1 patient had infective complications necessitating Girdlestones. 11 patients were lost to follow up, 8 patients were diagnosed pre operatively on Co and Cr levels in urine or synovial fluid aspirate alone. 23 patients had pre revision blood or serum metal ion level results available for direct comparison. Median serum Co level pre revision was 176.6nM/L, falling post revision to 5.1nM/L (p=<0.001∗). The median whole blood Cr level pre revision was 117nM/L and 19nm/L post revision (p=<0.001∗). Mean Oxford Hip Score was 23.7. DISCUSSION. This study demonstrates that at greater than one year post removal of a large diameter MoM hip implant for the indication of symptomatic metallosis or metal hypersensitivity, metal ion levels fall to almost normal levels and that outcome of revision surgery in terms of patient satisfaction is not adversely affected


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 323 - 323
1 Sep 2012
Li C Hussain A Joseph P Kamali A
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INTRODUCTION. One of the recent advances in the hard-on-hard hip arthroplasty is the development of a new material of diffusion hardened oxidised zirconium (DHOxZr). The DHOxZr material consists of a ceramic layer on the top surface which is supported by a thick oxygen diffusion hardened (DH) zone underneath. With the desired properties of metal substrate, ceramic surface and a gradient structure of the oxygen diffusion zone, the DHOxZr-on-DHOxZr bearing combination is expected to produce low wear and minimal metal ions. This can possibly address the concerns associated with metal hypersensitivity associated with metal on metal bearings and fracture risk associated with ceramics. The aim of this study was to evaluate the wear of DHOxZr-on-DHOxZr as a possible hard on hard bearing combination in hips. METHODS. Three pairs of 50 mm DHOxZr prototype hip joint devices, each consisting of a DHOxZr modular head and a DHOxZr liner were wear tested in a ProSim hip joint simulator under standard testing conditions used by the Implant Development Centre (IDC), Smith & Nephew, Leamington Spa for 5 million cycles (Mc). The flexion/extension was 30° and 15°. The internal/external rotation was ± 10°. The force was Paul-type stance phase loading, with a maximum load of 3 kN and a standard ISO swing phase load of 0.3 kN. The test frequency was 1 Hz. Gravimetric analysis was carried out at 0, 0.5, 1, 2, 3, 4 & 5 million cycles. The lubricant was new born calf serum with 2 g/l sodium azide concentration diluted with de-ionised water to achieve average protein concentration of 20 g/l. Lubricant was changed every 0.25Mc during the first million cycles of the test and at every 0.33 Mc from 1 to 5Mc. RESULTS. A biphasic wear pattern was observed for the DHOxZr on DHOxZr devices during the test, with a running in phase from 0–1 Mc and a steady state phase from 1–5 Mc. At a confidence level of 95%, the mean wear rate was 0.21 ±0.06 mm3/Mc during the running-in stage, and the wear rate was reduced to 0.01 ±0.03 mm3/Mc during the steady state for the device tested. The wear volume loss of the DHOxZr on DHOxZr devices was significantly lower than that generated by CoCrMo metal on metal (MoM) devices (p < 0.05) under identical simulator test conditions


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 572 - 572
1 Sep 2012
Khan A Ebreo D El Meligy M Armstrong C Peter V
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Introduction. The advantages of metal on metal (MOM) hip replacement are decreased wear rate, preservation of bone stock, anatomical restoration and enhanced stability. Large amounts of metal wear particles and metal ions are released which may induce adverse reactions including local soft tissue toxicity, hypersensitivity reactions, bone loss and risk of carcinogenesis. Aseptic loosening can be the result of a peri prosthetic osteolysis generated as a result of a biological response to particulate wear debris. Our aim in this study was to determine whether a steeply inclined acetabular component would give rise to a higher concentration of metal ions. Patients and methods. Between April 2003 and June 2006, 22 patients had MOM hip replacement for osteoarthritis by a single Surgeon. There were 12 male and 10 female patients. The average age at the time of surgery was 56 years (Range: 44–69 years). We divided the 22 patients into 2 groups, one group (A) of 11 patients with the acetabular inclination angle more than 50 degrees and the other group (B) of 11 patients with the angle less than 50 degrees. The inclination of the acetabular cup was measured using a standard AP radiograph of the pelvis. The patients had metal ion levels (blood chromium and serum cobalt) measured at an average follow up of 3.2 years (Range 2.4 to 5 years). Results. Mean blood chromium level in the group A (146 nM/L) was significantly higher (p=0.005) than in Group B (92 nM/L). Mean serum cobalt level in the group A (245 nM/L) was significantly higher (p=0.002) than in Group B (110 nM/L). Discussion. The early to mid term published results of MOM hip replacements have been encouraging. There are, however, a number of concerns about the MOM bearing. Although its wear rate is low, it still releases metal ions into the body particularly cobalt and chromium since most metal on metal bearings are made of a cobalt chromium alloy. The long-term consequences of increased levels of these ions in the body are not known. High concentrations of Co and Cr are toxic and are known to interfere with a number of biological functions. There also have been recent reports of soft tissue reactions with MOM hip replacement. In the light of these concerns, it is important to examine factors which may influence the release of metal ions after MOM hip replacement. It has been reported in the recent literature that the position of the acetabular component will influence the bearing wear inturn leading to the release of metal ions after MOM hip replacement. Our findings indicate that steeply inclined acetabular components with an inclination angle greater than 50 degrees gives rise to higher concentration of metal ions


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 550 - 550
1 Sep 2012
Singisetti K Raju P Langton D Nargol A
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INTRODUCTION. A detailed clinical examination and investigations are required to evaluate the cause of persisting groin pain following a metal on metal (MoM) hip replacement. Adverse reaction to metallic debris (ARMD) is an emerging problem with MoM hip replacements. It is an umbrella term encompassing metallosis, pseudo-tumors and aseptic lymphocytic vasculitis associated lesions (ALVAL). The role of imaging in the diagnosis of this complex problem is still unclear. A study was undertaken to evaluate the efficacy of ultrasound in diagnosis of ARMD following a MoM hip replacement. METHODS. The study group included 35 patients with a clinical and histological diagnosis of ARMD, who had a preoperative ultrasound. All ultrasound procedures were performed on the anterior and lateral aspects of the painful hip with a high frequency probe of 9–13 MHz (Sonoline Antares – Siemens). RESULTS. All patients diagnosed with ARMD had abnormalities identified on ultrasound. Fluid inside the joint was noted in 30 out of 35 procedures (85.7 %). Fluid outside the joint was noted in 33 procedures (94.3 %). Amongst the patients with fluid outside the joint, 32 had iliopsoas and 30 had trochanteric bursitis. Echogenic reflections were noted in 31 out of 35 procedures (88.6 %). Considerable attenuation or absence of iliopsoas and gluteus tendon reflection was seen in many patients with echogenic fluid collections on the anterior and trochanteric aspects of hip. Progression of such changes was noted on further 5 patients, who had a repeat ultrasound within an interval of 3–6 months. 1 patient had a progression from anechogenic to echogenic joint effusion. DISCUSSION. Different radiological investigations including MRI scan have been used for evaluation of painful MoM hip arthroplasty. To our knowledge, this is the first study to demonstrate the efficacy of ultrasound in diagnosis of ARMD. Floating echogenic reflections and fluid collections around iliopsoas and gluteus medius/minimus tendons is highly suggestive of ARMD. Ultrasound is a cheap, non-invasive and dynamic investigation and has been shown to be reliable in diagnosis of ARMD


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 94 - 94
1 Sep 2012
Penny J Varmarken J Ovesen O Nielsen C Overgaard S
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Introduction. Metal on metal articulations produce chromium (Cr) and cobalt (Co) debris, particularly when the articulations are worn in. High levels in the peripheral blood are indicative of excess wear and may cause adverse effects. The present RCT investigates metal ion levels and the relationship of Co, Cr ions and lymphocyte counts during the running-in period. Materials and Methods. Following randomization to RHA (ASRTM, DePuy) or THA we obtained whole blood (wb), and serum (s) samples at baseline, 8 w, 6 m and 1 y. We measured the Co and Cr concentrations, the total lymphocyte count as well as the CD3+, CD4+, CD8+, CD19+ and CD16+/CD56+ sub populations. Cup inclination and anteversion angles came from conventional radiographs. Activity was measured as steps by pedometer and UCLA activity. Data are presented as median (range). Results. We had 19 patients in each group. Age 57 (46–64) y (RHA) and 55 (44–64) y (THA). RHA only: head size: 51 (47 to 57)mm, cup inclination: 45.0 (40- 56)° and anteversion: 23 (7–38)°. The ion concentrations stayed below 0.2 ppb for THAs. For RHAs the Co and Cr concentrations generally rose markedly in the initial 8 weeks, followed by a slower ascent up to 1 year to wb Co: 1.0 (0.6–5.2), s Co: 1.3 (0.7–6.5), wb Cr: 1.3 (0.4–8.0) and s Cr: 1.7 (0.6–15) ppb. A high ion level was correlated to a small head size (p<0.03) and a cup inclination around 45° (p<0.04). We could not correlate the ion concentrations to the anteversion or the activity levels. The absolute lymphocyte counts were not always identical in the groups (eg. lower CD8+ for RHA) but there was no group difference when we analysed the change from baseline. We did not demonstrate any correlation between metal ion levels and lymphocyte subpopulations. Discussion. The findings of this study does not support the theory that metal ions suppress the lymphocytes or the CD8+ in particular (Hart et al., 2009). Our conclusions are limited by low numbers, but we suspect the theory could be biased by missing baseline values. Our study did not demonstrate the same 6–9 months ion peak found in other running-in studies (Back et al., 2005, Heisel et al., 2008), but rather a slow continuous rise with lower median ion concentrations. It could indicate lower wear or perhaps a longer running in period in our slightly older population. Contrary to our expectations we found that cups placed in optimal inclination displayed a higher ion level. Most of the smallest cups were found in this group, and the majority of the steep cups had very large heads. For this implant head size may be more important than cup position


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 177 - 177
1 Sep 2012
Christofilopoulos P Lübbeke A Berton C Lädermann A Berli M Roussos C Peter R Hoffmeyer P
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Introduction. Large diameter metal on metal cups have been used in total hip arthroplasty advocating superior results with respect to dislocation rates, range of motion and long term survival. The Durom cup used as part of the Durom hip resurfacing system has been incriminated with poor short term results sometimes correlated to incorrect positioning of either the femoral or acetabular component. Our objective was to evaluate short term results of the Durom cup used in conjunction with standard stems. Methods. We prospectively followed all patients with a large diameter metal-on-metal articulation (Durom) and a standard stem operated upon between 9/2004 and 9/2008. Patients were seen at follow-up for a clinical (Harris hip score=HHS, UCLA scale and patient satisfaction), radiographic and questionnaire assessment. Results. 89 primary THAs in 80 patients (74% men) with a mean age of 52 (±12) years were included. Main diagnoses were primary osteoarthritis in 47% and aseptic necrosis in 35%. An uncemented stem was used in 79%. Overall, 80 THAs were controlled at a mean follow-up of 39 months (range 16–67 months), 4 patients were lost to follow-up and 5 patients refused or were unable to attend the visit. However, none of the 5 underwent revision. Overall, 8 THAs (8/85, 9.4%) were revised in mean 28 months (range 8–60) after the operation. One additional patient was awaiting revision for aseptic loosening of both cup and stem. The reasons for revision were aseptic loosening in three cases, presence of a granuloma (histological diagnosis of ALVAL) in three, deep infection in one and impingement in one case. Radiographic analysis revealed linear (n=2) and focal (n=3) osteolysis as well as early cup migration (n=2). In 5 revised patients no radiographic changes were found. 56 (70%) of the 80 patients with follow-up had a HHS between 80 and 100. Among those who were not revised, the mean HHS improved from 55.2 to 88.4 (mean increase 33.2, 95% CI 27.7; 38.7). The mean activity level (UCLA scale) at follow-up was 6.4 (±1.8). Overall, mild to severe pain was reported in 14 cases and occasional pain in 22. Groin pain was present in 18 patients (22.5%), 7 of them belonged to the revised group. 61 (76.3%) of the 80 patients with follow-up were satisfied. Mean patient satisfaction on the VAS scale among those who were not revised was 9.0 (±1.3). Conclusion. This study confirms the increased short-term revision rate of the large diameter metal-on-metal couple (Durom) reported by others. In all revision cases the retrieved cups showed no osteo-integration and were removed easily. The operative indication for revision was based upon groin pain and patient dissatisfaction. Radiographic signs of implant loosening were not always present even though in all revised cases except for one the cup was found loose