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Bone & Joint Research
Vol. 9, Issue 8 | Pages 515 - 523
1 Aug 2020
Bergiers S Hothi H Henckel J Eskelinen A Skinner J Hart A

Aims. The optimum clearance between the bearing surfaces of hip arthroplasties is unknown. Theoretically, to minimize wear, it is understood that clearances must be low enough to maintain optimal contact pressure and fluid film lubrication, while being large enough to allow lubricant recovery and reduce contact patch size. This study aimed to identify the relationship between diametrical clearance and volumetric wear, through the analysis of retrieved components. Methods. A total of 81 metal-on-metal Pinnacle hips paired with 12/14 stems were included in this study. Geometrical analysis was performed on each component, using coordinate and roundness measuring machines. The relationship between their as-manufactured diametrical clearance and volumetric wear was investigated. The Mann-Whitney U test and unpaired t-test were used, in addition to calculating the non-parametric Spearman's correlation coefficient, to statistically evaluate the acquired data. Results. The hips in this study were found to have had a median unworn diametrical clearance of 90.31 μm (interquartile range (IQR) 77.59 to 97.40); 32% (n = 26) were found to have been below the manufacturing tolerance. There was no correlation found between clearance and bearing (r. s. = -0.0004, p = 0.997) or taper (r. s. = 0.0048, p = 0.966) wear rates. The wear performance of hips manufactured within and below these specifications was not significantly different (bearing: p = 0.395; taper: p = 0.653). Pinnacles manufactured from 2007 onwards had a greater prevalence of bearing clearance below tolerance (p = 0.004). Conclusion. The diametrical clearance of Pinnacle hips did not influence their wear performance, even when below the manufacturing tolerance. The optimum clearance for minimizing hip implant wear remains unclear. Cite this article: Bone Joint Res 2020;9(8):515–523


Bone & Joint Research
Vol. 7, Issue 11 | Pages 595 - 600
1 Nov 2018
Bergiers S Hothi HS Henckel J Eskelinen A Skinner J Hart A

Objectives. Previous studies have suggested that metal-on-metal (MoM) Pinnacle (DePuy Synthes, Warsaw, Indiana) hip arthroplasties implanted after 2006 exhibit higher failure rates. This was attributed to the production of implants with reduced diametrical clearances between their bearing surfaces, which, it was speculated, were outside manufacturing tolerances. This study aimed to better understand the performance of Pinnacle Systems manufactured before and after this event. Methods. A total of 92 retrieved MoM Pinnacle hips were analyzed, of which 45 were implanted before 2007, and 47 from 2007 onwards. The ‘pre-2007’ group contained 45 implants retrieved from 21 male and 24 female patients, with a median age of 61.3 years (interquartile range (IQR) 57.1 to 65.5); the ‘2007 onwards’ group contained 47 implants retrieved from 19 male and 28 female patients, with a median age of 61.8 years (IQR 58.5 to 67.8). The volume of material lost from their bearing and taper surfaces was measured using coordinate and roundness measuring machines. These outcomes were then compared statistically using linear regression models, adjusting for potentially confounding factors. Results. There was no significant difference between the taper and bearing wear rates of the ‘pre-2007’ and ‘2007 onwards’ groups (p = 0.67 and p = 0.39, respectively). Pinnacles implanted from 2007 onwards were revised after a mean time of 50 months, which was significantly earlier than the ‘pre-2007’ hips (96 months) (p < 0.001). A reduction in the time to revision was present year on year from 2003 to 2011. Conclusion. We found no difference in the wear rate of these implants based on the year of implantation. The ‘pre-2007’ hips had a two-fold greater time to revision than those implanted after 2007; this may be due to the increased surveillance of MoM hips following UK regulatory advice and several high-profile failures. Interestingly, we observed a decreasing trend in the mean time to revision every year from 2003 onwards. Cite this article: S. Bergiers, H. S. Hothi, J. Henckel, A. Eskelinen, J. Skinner, A. Hart. Wear performance of retrieved metal-on-metal Pinnacle hip arthroplasties implanted before and after 2007. Bone Joint Res 2018;7:595–600. DOI: 10.1302/2046-3758.711.BJR-2018-0143.R1


The Bone & Joint Journal
Vol. 99-B, Issue 5 | Pages 592 - 600
1 May 2017
Matharu GS Nandra RS Berryman F Judge A Pynsent PB Dunlop DJ

Aims. To determine ten-year failure rates following 36 mm metal-on-metal (MoM) Pinnacle total hip arthroplasty (THA), and identify predictors of failure. Patients and Methods. We retrospectively assessed a single-centre cohort of 569 primary 36 mm MoM Pinnacle THAs (all Corail stems) followed up since 2012 according to Medicines and Healthcare Products Regulation Agency recommendations. All-cause failure rates (all-cause revision, and non-revised cross-sectional imaging failures) were calculated, with predictors for failure identified using multivariable Cox regression. Results. Failure occurred in 97 hips (17.0%). The ten-year cumulative failure rate was 27.1% (95% confidence interval (CI) 21.6 to 33.7). Primary implantation from 2006 onwards (hazard ratio (HR) 4.30; 95% CI 1.82 to 10.1; p = 0.001) and bilateral MoM hip arthroplasty (HR 1.59; 95% CI 1.03 to 2.46; p = 0.037) predicted failure. The effect of implantation year on failure varied over time. From four years onwards following surgery, hips implanted since 2006 had significantly higher failure rates (eight years 28.3%; 95% CI 23.1 to 34.5) compared with hips implanted before 2006 (eight years 6.3%; 95% CI 2.4 to 15.8) (HR 15.2; 95% CI 2.11 to 110.4; p = 0.007). Conclusion. We observed that 36 mm MoM Pinnacle THAs have an unacceptably high ten-year failure rate, especially if implanted from 2006 onwards or in bilateral MoM hip patients. Our findings regarding implantation year and failure support recent concerns about the device manufacturing process. We recommend all patients undergoing implantation since 2006 and those with bilateral MoM hips undergo regular investigation, regardless of symptoms. Cite this article: Bone Joint J 2017;99-B:592–600


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 11 - 11
1 Jan 2016
Al-Khateeb H Mahmud T MacDonald S McAuley JP
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Objectives. Porous metal surfaces have been a popular option for acetabular component fixation in total hip arthroplasty (THA). New THA component designs are introduced periodically with the expectation of better wear properties and survivorship. Since its approval for use in 2002 there have been few clinical outcome studies published on the Pinnacle acetabular cup system. We hypothesised that the hemispherical porous coated Pinnacle acetabular cup system with a range of cup options and bearing surfaces would give us predictably good fixation and survivorship at five years post implantation. Materials and Methods. A total of 1391 Pinnacle acetabular cups (De Puy, a Johnson & Johnson company, Warsaw IN) were implanted between the period March 2003 to August 2011 by four senior surgeons. There were a total of 29 patients requiring revision surgery. Of these revisions, 23 were excluded from the final analysis. Sixteen were for early infection requiring debridement of the hip joint and exchange of the modular liner and femoral head. Five patients sustained femoral peri-prosthetic fractures requiring further surgery with retention of the acetabular component in all cases. Of the remaining 8 revision cases, only 6 had more than two years follow-up. All patients had pre and post-operative Harris hip scores, WOMAC and SF-12 scores. All patients were assessed with serial radiographs immediately post-operatively, 3 months, 1 year, 2 years, every 2 years thereafter. Component migration and revisions (excluding infection and peri-prosthetic fractures) are reported as failures. Post-operative radiographs were evaluated for component migration. Kaplan-Meier survivorship curves were drawn to show survivorship for cup type and bearing type. Results. A total of 894 Pinnacle acetabular components implanted into 796 patients were available for inclusion in the final analysis. There were 358 males with an average age of 63.70 years and 438 females with an average age of 64.55 years. The average period for follow-up was 44.95 months with 133 patients having more than five years of follow-up. Only one cup showed signs of aseptic loosening and component migration on plain radiographs, this patient had previously sustained an acetabular fracture requiring open reduction and internal fixation ans subsequently developed osteoarthritis. The cup failed to adequately in-grow and migrated medially to an intra-pelvic position, this was revised to a Trabelcular Metal cup with bone grafting to the acetabulum. There were two cases revised for instability. Three revisions were performed for aseptic loosening of the femoral components which were revised with retention of the acetabular cups. Conclusion. Published data on the performance of various porous coated cups have demonstrated varying degrees of osteolysis, however the Pinnacle cup has shown excellent midterm results postulated to be associated with the taper lock liner mechanism of the Pinnacle cups resulting in less micromotion and, therefore, reduced hydraulic pressure pumping polyethylene wear debris behind the cup. Our study confirms excellent overall survivorship of the Pinnacle acetabular porous coated cup system at a minimum of two years followup in over 790 patients


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_5 | Pages 39 - 39
1 Jul 2020
El-Bakoury A Parkar A Powell J
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Background. One of the potential complications of polyethylene liner (PL) is its dissociation from the metal shell. This is a rare but catastrophic complication of total hip replacement (THR). Objective. was to analyze the retrieved dissociated components (PL and shell) (Depuy Pinnacle, Warsaw, IN, USA) to evaluate the mechanism of failure. All these components were dissociated within four years of implantation. Methods. Components were retrieved from three different centers in Canada over the period from January 2011 to October 2016. The analysis was done at the Orthopaedic Innovation Centre (OIC) in Winnipeg Canada. Nine PLs were retrieved at the time of revision THR. Assessment using optical and scanning electron microscopies at magnification between 25× and 150× was performed. The following questions were asked: 1) were the liners correctly seated at the primary surgery? 2) Are there signs of impingement present which could have caused the liner to become dissociated? 3) Does the wear pattern indicate that the liner was failing prior to dissociation?. Results. All PLs dissociated in the inferior direction. Five PL were believed to have been seated properly at the time of indexed surgery. All PL displayed signs of post dissociation impingement. Only 1 PL had fractured resulting in failure prior to dissociation. Other PL showed signs of wear, however none of them reached thinness that would be a cause for concern. Eight PLs demonstrated shearing of the anti rotation tabs. Assessment of the anti rotation tabs revealed that a couple had sheared off suddenly while remaining anti rotation tabs sheared off in progressive fatigue resulting in the failure of the locking mechanism. Conclusions. Retrieval analysis was useful in identifying common patterns of failure such as anti-rotation tab damage. This was suggestive that the locking mechanism of the acetabular components has probably failed in 8 out of 9 of the retrieved liners


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_12 | Pages 50 - 50
1 Jun 2017
Bolland B Cook E Tucker K Howard P
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This study utilized data from the NJR dataset on all Corail/Pinnacle total hip replacements (THR) to determine (a) the level of unit variation of the Corail/Pinnacle 36mm Metal On Metal THR within England and Wales; (b) patient, implant and surgeon factors that may be associated with higher revision rates; (c) Account for the influence of the MHRA announcement in 2010. The national Revision Rate (RR) for the Corail / Pinnacle MOM THR was 10.77% (OR:1.46; CI:1.17–1.81). This was significantly greater than other articulation combinations (MOP 1.72%, COP 1.36%, COC 2.19%). The 2010 MHRA announcement did not increase rate of revision (X. 2. =1649.63, df=13, p<.001). Patient factors associated with significantly increased revision rates included, female gender (OR 1.38 (CI 1.17–1.63, p<.001) and younger age OR 0.99 (CI 0.98–0.99), p<.001). Implant factor analysis demonstrated an inverse relationship between cup size and revision. As head length increased RR increased – highest risk of revision +12.5 (OR 1.69 (CI 1.12–2.55), p=0.13). Coxa vara, high offset stems had a higher risk of revision compared to standard offset stems (OR:1.41 (CI 1.15–1.74; p<.001). As stem size increased risk of revision decreased (OR 0.89 (CI 0.85–0.93); p<.001). Surgeon grade did not influence RR. There was significant variation in RR between hospitals with 7 units (7/61 excluding low volume centres, <50 implants) identified as having significant higher rates of revision. However, for each of these units there was a greater proportion of higher risk patients (female, cup size 50–54, stem type). This study has provided insight into unit variation, risk factors and the long term outcome of the Corail/Pinnacle 36mm MOMTHR. Future aims are to use these results to develop a risk stratified algorithm for the long term follow of these patients to minimize patient inconvenience and excess use of limited NHS resources


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 43 - 43
1 Jan 2016
Hirayama T Sasaki K Takakubo Y Ito J Takagi M
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Background. Large head metal on metal total hip arthroplasty MOM THA have been consistently shown substantial improvement in wear performance compared with metal on polyethylene articulations. Large diameter femoral heads theoretically can reduce dislocation risk by increasing range of motion before impingement, increasing prosthetic jump distance. However, early failure associated with adverse local tissue reactions (ALTRs) to metal debris is an emerging problem after MOM THA. The purpose of this study was to evaluate mid-term results of MOM THA. Materials and Methods. Twenty-five patients, 28 hips were included in this study. The average age of the patients at the time of surgery was 66.9 years. Three patients were men and 22 were women. MOM THAs were performed using 28 PINNACLE Cup system (DepPuy) (C-STEM: 23, S-ROM: 5) with posterior approach and head size of 36mm. Twenty-five primary THAs due to osteoarthritis in 22 cases and rheumatoid arthritis (RA) in one, and two revisions due to recurrent dislocation THA patients, were performed. The average follow up was 56.7 months. Evaluation items are JOA score, cup anteversion /lateral opening angle, and complications. Indication of the system were applied for patients with high risk of dislocation such as recurrent dislocation in primary and/or THAs, posterior pelvic tilt, elderly, RA and mental disorders. Results. The average JOA score improved from 48.3 (range: 26–77) preoperatively to 88.3 (range: 55–100) postoperatively. The average cup anteversion was 21.7 degrees (range: 2–38) and average lateral opening was 45.5 degrees (range: 37–60). Three patients (12%) developed dislocation. Two patients (8%) required reoperations from the deep infection. One female patient (4%) remained hip pain and was suspected pseudotumor / ALTR, which was confirmed by computed tomography and magnetic resonance imaging. Conclusion. Large femoral head MOM THA was useful for patients with recurrent dislocation in revision THA. However, three patients developed dislocation in primary THAs (12% of primary cases), which suggested that the more accurate placement of the acetabular cup is important even in the large diameter cup. Although only one case (4%) revealed ALTR, however, continuous careful follow-up would be necessary in the MOM system


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_9 | Pages 29 - 29
1 May 2018
Hothi H Eskelinen A Henckel J Blunn G Skinner J Hart A
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Introduction. Numerous studies have reported on clinically significant volumes of material loss and corrosion at the head-stem junction of metal-on-metal (MOM) hips; less is understood about metal-on-polyethylene (MOP) hips. We compared the effect of bearing type (MOM vs MOP) on taper material loss for a hip system of a single design (DePuy Pinnacle). Methods. We recruited retrieved MOM (n=30) and MOP (n=22) bearing hips that were consecutively received at our centre. We prospectively collected associated clinical and imaging data. We measured the severity of corrosion and volumes of material loss at each head taper surface and used multivariate statistical analysis to investigate differences between the two bearing types. Results. The median rate of material loss for the MOM and MOP groups was 0.81 mm. 3. /year (0.01–3.45) and 0.03 mm. 3. /year (0–1.07) respectively (p<0.001). 29 out of 30 MOM hips were revised for adverse metal reactions, compared with 1 out of 22 MOP hips. Discussion. MOP hips lost significantly less material from their taper junctions than MOM hips. We suggest that the metal-metal interaction at the bearing surface of MOM hips enhances the corrosive environment at the head-stem junction. Conclusion. Our results can reassure patients with MOP Pinnacle hips that they are unlikely to experience clinically significant problems related to material loss from the taper junction


Bone & Joint Open
Vol. 2, Issue 5 | Pages 293 - 300
3 May 2021
Lewis PM Khan FJ Feathers JR Lewis MH Morris KH Waddell JP

Aims. “Get It Right First Time” (GIRFT) and NHS England’s Best Practice Tariff (BPT) have published directives advising that patients over the ages of 65 (GIRFT) and 69 years (BPT) receiving total hip arthroplasty (THA) should receive cemented implants and have brought in financial penalties if this policy is not observed. Despite this, worldwide, uncemented component use has increased, a situation described as a ‘paradox’. GIRFT and BPT do, however, acknowledge more data are required to support this edict with current policies based on the National Joint Registry survivorship and implant costs. Methods. This study compares THA outcomes for over 1,000 uncemented Corail/Pinnacle constructs used in all age groups/patient frailty, under one surgeon, with identical pre- and postoperative pathways over a nine-year period with mean follow-up of five years and two months (range: nine months to nine years and nine months). Implant information, survivorship, and regular postoperative Oxford Hip Scores (OHS) were collected and two comparisons undertaken: a comparison of those aged over 65 years with those 65 and under and a second comparison of those aged 70 years and over with those aged under 70. Results. Overall revision rate was 1.3% (13/1,004). A greater number of revisions were undertaken in those aged over 65 years, but numbers were small and did not reach significance. The majority of revisions were implant-independent. Single component analysis revealed a 99.9% and 99.6% survival for the uncemented cup and femoral component, respectively. Mean patient-reported outcome measures (PROMs) improvement for all ages outperformed the national PROMs and a significantly greater proportion of those aged over 65/69 years reached and maintained a meaningful improvement in their OHS earlier than their younger counterparts (p < 0.05/0.01 respectively). Conclusion. This study confirms that this uncemented THA system can be used safely and effectively in patient groups aged over 65 years and those over 69 years, with low complication and revision rates. Cite this article: Bone Jt Open 2021;2(5):293–300


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 58 - 58
19 Aug 2024
Karachalios T Hasan Y Aqeel M
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Total hip arthroplasty (THA) has proved to be an effective treatment modality for sickle-cell hip arthropathy (mosaic-like dense bone due to infarcts). However, mode of failure, survival rates and challenges associated with revision hip arthroplasty in sickle-cell disease patients are mostly unknown. We retrospectively evaluated prospectively collected data from all patients with sickle-cell disease who underwent revision hip arthroplasty from 2016. Patient, surgery, medical and surgical complications related data were collected. The pinnacle and reclaim revision system with gription augments (JJ) was used in all patients. Pre-op and post-op clinical outcome data (both objective and subjective, HOOS Jr and OHS) were recorded. Cumulative success rates were recorded with re-revision surgery as an end point. We performed fifteen revision THAs on 13 patients (mean follow up of 6.6 years). The mean age of the patients was 48 years (range, 30–59). At final follow-up, a statistically significant improvement of mean OHS and HOOS JR scores eas found in all patients. reported (OHS: 34.0 and HOOS JR: 77.7). Cumulative success rate was 100% for re-revision for all reasons at 6 years. Five intensive care unit (ITU) admissions, two vaso-occlusive sickle cell crises, one transfusion-related complication and one acute chest syndrome (ACS) were recorded. On admission, the mean percentage of HbS was 75.25% (64.6–86.4%). Revision arthroplasty in sickle-cell disease patients poses increased risks, with medical and surgical challenges. However, with careful preparation, planning and a multi-disciplinary team approach, revision arthroplasty can result in excellent clinical outcomes and excellent functional scores in the majority of patients in the short and mid-term


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 57 - 57
11 Apr 2023
Etchels L Wang L Thompson J Wilcox R Jones A
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Variations in component positioning of total hip replacements can lead to edge loading of the liner, and potentially affect device longevity. These effects are evaluated using ISO 14242:4 edge loading test results in a dynamic system. Mediolateral translation of one of the components during testing is caused by a compressed spring, and therefore the kinematics will depend on the spring stiffness and damping coefficient, and the mass of the translating component and fixture. This study aims to describe the sensitivity of the liner plastic strain to these variables, to better understand how tests using different simulator designs might produce different amounts of liner rim deformation. A dynamic explicit deformable finite element model with 36mm Pinnacle metal-on-polyethylene bearing geometry (DePuy Synthes, Leeds, UK) was used with material properties for conventional UHMWPE. Setup was 65° clinical inclination, 4mm mismatch, 70N swing phase load, and 100N/mm spring. Fixture mass was varied from 0.5-5kg, spring damping coefficient was varied from 0-2Ns/mm. They were changed independently, and in combination. Maximum separation values were relatively insensitive to changes in the mass, damping coefficient, or both. The sensitivity of peak plastic strain, to this range of inputs, was similar to changing the swing phase load from 70N to approximately 150N – 200N. Increasing the fixture mass and/or damping coefficient increased the peak plastic strain, with values from 0.15-0.19. Liner plastic deformation was sensitive to the spring damping and fixture mass, which may explain some of the differences in fatigue and deformation results in UHMWPE liners tested on different machines or with modified fixtures. These values should be described when reporting the results of ISO14242:4 testing. Acknowledgements. Funded by EPSRC grant EP/N02480X/1; CAD supplied by DePuy Synthes


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 5 - 5
1 Sep 2012
Smith J Railton P Kinniburgh D Faris P David L Marshall D Burkart B Powell J
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In a cross sectional cohort study three different metal on metal total hip systems were assessed. Two monoblock acetabular designs; the Durom socket (Zimmer, Warsaw, In) and the Birmingham socket (Smith and Nephew, Memphis, TN), and one modular metal on metal total hip system (Pinnacle, Depuy Orthopaedics, Warsaw, In) in patients who have received these implants in the our region. 56 patients were recruited in total. All patients were assessed clinically, radiologically and biochemically. Whole blood Cobalt, Chromium and titanium levels were tested. The median head size used in the Birmingham group was 52mm (Range 44mm to 56mm), and in the Durom group, 48mm (Range 42 to 54mm). The median head size used in the modular Pinnacle group was 40mm (Range 36–44mm). The blood metal ions levels in the larger non modular acetabular sockets were significantly raised compared to the Pinnacle group. For Co 1.95 µg/l and 2.70 µg/l in the Durom and Birmingham groups respectively compared to only 0.52 µg/l in the Pinnacle group (P< 0.001). Mean Cr levels were the same for the two monoblock systems, 1.9 µg/l compared to the Pinnacle sockets 1.2 µg/l (P< 0.001). Our study clearly demonstrates that there is a significant difference in metal ion levels in patients following a monobloc large head arthroplasty system compared to a smaller modular metal on metal hip arthroplasty. The smaller head size appears to produce less metal ions whilst at the same time a 36mm–44mm head size is large enough to increase hip stability and range of movement as well as decreasing the risk of impingement. In our practice we are no longer using this design and the safest strategy, when considering metal on metal bearings, is to use a modular, smaller head system such as the Pinnacle


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 44 - 44
1 Dec 2022
Turgeon T Bohm E Gascoyne T Hedden D Burnell C
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This study used model-based radiostereometric analysis (MBRSA) to compare migration of a recently introduced cementless hip stem to an established hip stem of similar design. Novel design features of the newer hip stem included a greater thickness of hydroxyapatite coating and a blended compaction extraction femoral broach. Fifty-seven patients requiring primary total hip arthroplasty (THA) were enrolled at a single centre. Patients were randomized to receive either an Avenir collarless stem and Trilogy IT cup (ZimmerBiomet) or a Corail collarless stem and Pinnacle cup (DePuy Synthes) via a posterior or lateral approach. Both stems are broach-only femoral bone preparation. RSA beads (Halifax Biomedical) were inserted into the proximal femur during surgery. Patients underwent supine RSA imaging a 6 weeks (baseline), 6, 12, and 24 months following surgery. The primary study outcome was total subsidence of the hip stem from baseline to 24 months as well as progression of subsidence between 12 and 24 months. These values were compared against published migration thresholds for well-performing hip stems (0.5mm). The detection limit, or precision, of MBRSA was calculated based on duplicate examinations taken at baseline. Patient reported outcome measures were collected throughout the study and included the Oxford-12 Hip Score (OHS), EuroQoL EQ-5D-5L, Hip Osteoarthritis Score (HOOS) as well as visual analogue scales (VAS) for thigh pain and satisfaction. Analysis comprised of paired and unpaired t-tests with significance set at p≤0.05. Forty-eight patients (30 males) were included for analysis; 7 patients received a non-study hip stem intra-operatively, 1 patient suffered a traumatic dislocation within three weeks of surgery, and 1 patient died within 12 months post-surgery. RSA data was obtained for 45 patients as three patients did not receive RSA beads intra-operatively. Our patient cohort had a mean age of 65.9 years (±;7.2) at the time of surgery and body mass index of 30.5 kg/m2 (±;5.2). No statistical difference in total stem migration was found between the Avenir and Corail stems at 12 months (p=0.045, 95%CI: −0.046 to 0.088) and 24 months (p=0.936, 95% CI: −0.098 to 0.090). Progression of subsidence from 12-24 months was 0.011mm and 0.034mm for the Avenir and Corail groups which were not statistically different (p=0.163, 95%CI: −0.100 to 0.008) between groups and significantly less than the 0.5mm threshold (pNo statistically significant differences existed between study groups for any pre-operative function scores (p>0.05). All patients showed significant functional improvement from pre- to post-surgery and no outcome measures were different between study groups with exception of EQ-5D-5L health visual analogue scale at 12 months which showed marginally superior (p=0.036) scores in the Avenir group. This study was not powered to detect differences in clinical outcomes. This study has demonstrated no statistical difference in subsidence or patient-reported outcomes between the Corail hip stem and the more recently introduced Avenir hip stem. This result is predictable as both stems are of a triple-tapered design, are coated with hydroxyapatite, and utilize a broach-only bone preparation technique. Both stem designs demonstrate migration below 0.5mm suggesting both are low-risk for aseptic loosening in the long-term


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 157 - 157
1 Sep 2012
Lee D Powell J Burkart B Smith J Kinniburgh D Faris P Parker R Marshall D Railton P
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Purpose. To determine whether there is a difference in the metal ion levels among three different metal-on-metal total hip systems: two monoblock large heads and one modular metal-on-metal total hip replacement system in patients who received these implants in our region. Method. A group of 56 patients were recruited that had either undergone total hip replacement (THR) with a Birmingham resurfacing socket, the Durom resurfacing socket, or a Pinnacle metal-on-metal bearing surface. All patients recruited were at least one year following their surgery in order that their ion levels had reached a steady state. We reviewed every patient clinically, radiographically as well as biochemically. Blood was obtained for cobalt (Co) and chromium (Cr) levels. Current radiographs were arranged to assess the stability and mechanics of the total hip systems. All patients signed an informed consent and completed three questionnaires, The Western Ontario and McMaster Universities (WOMAC) index, the Short Form 36 (SF36) and UCLA activity score. A Harris Hip score was completed in order to assess individual hip function. Statistical analysis was performed on the collected data to assess whether there were any other potential influence on the mean levels of Co and Cr. Results. The blood metal ion levels in the larger non modular acetabular sockets were significantly raised compared to the Pinnacle group. For Co, 1.95 parts per billion (ppb) and 2.70 ppb in the Durom and Birmingham groups respectively compared to only 0.52 ppb in the Pinnacle group (P< 0.001). Cr levels were the same in the two monoblock systems, 1.9 ppb compared to the Pinnacle sockets 1.2 ppb (P<0.001). In all groups however these levels were within an acceptable safe range. The mean head size used in the Birmingham group was 53.2mm (Range 44mm to 56mm), and in the Durom group, 47.1 (Range 42 to 54mm). The mean head size used in the modular group was 37.3mm (Range 36–44mm). There was no difference between the three groups in terms of functional outcome and patient demographics were similar in all three groups. There was no statistical difference between the groups in terms of anteversion and abduction angles. There was also a smaller spread in this group in terms of range of angles. There was also no relationship between these values and the metal ion levels. Conclusion. All three total hip systems demonstrated average metal ion whole blood levels in a safe range. Larger diameter metal on metal bearings had higher ion levels


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_6 | Pages 35 - 35
1 Apr 2018
Al-Hajjar M Lancaster-Jones OO Ali M Jennings L Williams S Fisher J
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Introduction and Aims. There are many surgical, implant design and patient factors that should be considered in preclinical testing of hip replacement which are not being considered in current standards. The aim of this study was to develop a preclinical testing method that consider surgical positioning, implant design and patient factors and predict the occurrence and severity of edge loading under the combination of such conditions. Then, assess the safety and reliability of the implant by predicting the wear, deformation and damage of the implant bearings under worst case conditions. Methods. Ceramic-on-ceramic (CoC, 36mm, BIOLOX. ®. delta, Pinnacle. ®. , DePuy Synthes, UK) and metal-on polyethylene (MoP, 36mm, Marathon®, Pinnacle. ®. , DePuy Synthes, UK) bearings were used for this study on multi-station multi-axis hip joint simulators. Two factors were varied, cup inclination angles (45° and 65°) and translational mismatch between the femoral head and acetabular cup (0, 2, 3 and 4 (mm)). Under each condition for both CoC and MoP bearings, three million cycles of gait cycle testing were completed with wear, deformation and/or damage measurements completed at one million cycle intervals. Other outputs of the study were the level of dynamic separation between the femoral head and acetabular cup during gait, the maximum force at the rim during edge loading when the head was sliding back to the cup confinement. Means and 95% confidence limits were determined and statistical analysis were done using one way ANOVA with significance taken at p<0.05. Results. As the level of mismatch and the cup inclination angle increased, the magnitude of dynamic separation and the force at the rim increased. The level of dynamic separation and the force on the rim correlated with the wear of CoC bearings (R= 0.96). For polyethylene, steeper inclination angle did not significantly increase the wear (p>0.05) however, edge loading under 4mm translational mismatch and steep cup inclination angle did (p<0.01). The combined wear and deformation of the polyethylene liners at the rim increased under larger levels of dynamic separation. Conclusions. The magnitude of dynamic separation and force at the rim were predictive of the severity of edge loading. These parameters can be measured using short term testing (500 cycles). This will determine the effect of variations in surgical positioning, implant design and patient factors on the occurrence and severity of edge loading. Then, the wear, deformation and/or damage on hip replacement bearings can be determined using longer term simulator testing under selected conditions. The short term tests do not only help identify worst case scenarios but may identify the boundary of surgical position under which the implants performance may be considered acceptable. A new approach for preclinical testing of hip replacement was developed:. Stage 1: Short biomechanical tests. : assess the occurrence and severity of edge loading conditions where the outputs are:. Magnitude of medial-lateral dynamic separation. Maximum force under edge loading. Stage 2: Wear assessment. : assess the tribological performance of hip replacement under selected conditions where the outputs are:. Wear rates. Deformation and/or damage on the bearing surface


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_10 | Pages 3 - 3
1 Oct 2020
Wellings EP Couch CG Taunton MJ Pagnano MW Berry DJ Abdel MP
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Introduction. Patients undergoing primary total hip arthroplasty (THA) following pelvic radiation have historically had poor survivorship free of aseptic acetabular component loosening. However, several series have reported improved results with tantalum acetabular components. The purpose of this study was to assess implant survivorship, radiographic results, and clinical outcomes of contemporary, non-tantalum, porous acetabular components in the setting of prior pelvic radiation. Methods. We retrospectively reviewed 33 patients (38 hips) with prior therapeutic pelvic radiation between 2006 and 2016 who underwent primary THA. The mean overall pelvic radiation dose was 6300 cGy with a mean latency period to THA of 5 years. The most common acetabular component was Pinnacle (Depuy-Synthes) in 76%, followed by Trident (Stryker) in 8%, Tritanium (Stryker) in 8%, Trilogy (Zimmer-Biomet) in 5%, and G7 (Zimmer-Biomet) in 3%. Eighty-seven percent of cups were fixed with screws, of which the mean number used was 3. The mean age at primary THA was 74 years, 76% were male, and the mean BMI was 30 kg/m. 2. Mean follow-up was 5 years. Results. The 10-year survivorship free of revision for aseptic loosening, free of any revision, and free of any reoperation were 100%, 89%, and 89%, respectively. There were three revisions; one each for taper corrosion, recurrent dislocation, and infection. Radiographically, all cups had evidence of osteointegration and none had radiographic evidence of loosening. The mean Harris hip score improved from 50 to 84 postoperatively (p<0.0001). Conclusion. Contemporary non-tantalum porous acetabular components with supplemental screws provided excellent implant fixation in patients with prior therapeutic pelvic radiation. At 10 years, 100% of these components were free of revision for aseptic loosening and 100% were radiographically well-fixed. Summary. Contemporary non-tantalum porous uncemented acetabular cups provided 100% survivorship free from revision for aseptic loosening for patients undergoing THA following therapeutic pelvic radiation


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 15 - 15
1 May 2016
Sasaki T Kodama T Ogawa Y
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Introduction. In recent years, an increasing number of reports related to adverse reactions to metal debris (ARMD) following metal-on-metal (MOM) total hip arthroplasty (THA) have been published. Some patients who experience ARMD require revision surgery. Objectives. In this study, we aimed to evaluate the mid-term results of MOM THA. Methods. We retrospectively reviewed all patients who underwent THA at JCHO Saitama medical center from January 2007 to December 2010. A metal liner and metal femoral head were used in 37 of 214 cases (17%). This sub-group comprised 2 men and 35 women (mean age at surgery, 63.5 years; range, 39–79 years). The original disease is 28 osteoarthritis, 5 osteonecrosis, 3 rheumatoid arthritis and 1 rapidly destructive hip coxarthropathy. We investigated the system type, size (cup, femoral head, and stem), and cup position (anteversion and inclination). Moreover, we used imaging (radiography and computed tomography [CT] or magnetic resonance imaging [MR]) to assess for aseptic loosening, metal hypersensitivity reactions, and pseudotumor formation. Results. Six women with osteoarthritis experienced significant localized soft tissue reactions, and underwent revision. The average duration to revision was 41months(range, 28–63). Of these, 4 patients had received the PINNACLE cup system (Depuy; 4/14, 28.6%) and 2 had received the M2a-Taper cup system (BIOMET; 2/23, 8.7%). The femoral head sizes of the PINNACLE system used was 36 mm, and the femoral head sizes of the M2q-Taper systems used were 28mm and 32mm. Four patients had no signs or symptoms, 1 patient complained of anterior thigh dullness and 1 patient had a dislocation. The average cup anteversion was 15.7 degrees (range, 10–19 degrees) and the average inclination was 49.2 degrees (range, 43–57 degrees). Conclusions. MOM THA was associated with a higher incidence of revision. The majority of cases that required revision had no severe signs or symptoms. Therefore, all cases of MOM THA should be assessed periodically using CT or MRI


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_13 | Pages 43 - 43
1 Sep 2014
Ashour R Maritz M Goga I
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Purpose of the study. We reviewed one hundred and twenty patients who had primary total hip replacement using Corail/Pinnacle Metal on metal bearing surfaces between 2006 and 2009. We were interested in the metal ion levels of the whole cohort, the incidence of unexplained pain, pseudo tumour lesions (ALVAL) and early loosening and failure. We were particularly interested in the relationship of the acetabular cup position in relation to the pelvis and lumbar spine. Material and methods. We reviewed 120 charts and 104 patients in total. All patients had metal ion assays (cobalt and chromium). All patients had standardised radiographic evaluation using a special technique to assess acetabular cup position and the relationship to the pelvis and lumbar spine. Results. Ten patients had mild hip pain. This was not considered to be pathological pain related to the MOM articulation. None of the patients had any generalised symptoms of metal allergy as reported in the literature. We detected one patient with soft tissue fluid collections suggestive of an ALVAL lesion on ultrasound. The average cup inclination was 48 degrees with a range from 34 to 53 degrees. Conclusion. Our experience at 5 years with the Corail/Pinnacle Metal on Metal articulation has been acceptable. NO DISCLOSURES


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 34 - 34
1 Jun 2016
Magill P Blaney J Hill J Beverland D
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Introduction. The results of cementless total hip arthroplasty (THA) vary with data from the UK national Joint Registry being less favourable than that from the Australian registry. The senior author started using a fully cementless THA in 2005 and we aimed to gauge the performance of the implants based on their revision data. Patients and methods. Between August 2005 and March 2015, 4,802 primary THA (4,309 patients) were performed with a cementless Corail. ®. stem and a cementless Pinnacle. ®. cup. There were 2,086 (43.4%) males and 2,716 (56.6%) females with a median age of 70 years (IQR 13, Range 16–95). There were a number of changes to the surgical technique with respect to the Corail. ®. stem during the ten-year period, which we have categorised as phase 1 and phase 2. We compared the data in the two phases. Data were extracted from a prospectively maintained patient information database. Results. A total of 80 (1.67%) revisions have been performed to date (median follow-up 65.9 months, IQR 46.8, Range 0 to 121), which is equivalent to a cumulative revision risk of 2.5% at ten years. Revision rate was not significantly different in those less than 70 years old (1.63%) compared to those greater than or equal to 70 years old (1.76%, P=0.81). The leading causes of revision were instability (n=22, 0.46%), infection (n=20, 0.42%) and aseptic loosening of the stem (n=15, 0.31%). More collarless stems than collared stems have been revised. Phase 2 changes in surgical technique resulted in cessation of collarless stem use, a small but significant increase in mean stem size, and a paradoxical decrease in iatrogenic femoral fracture. Conclusions. The overall revision rates of the Corail. ®. stem and Pinnacle. ®. cup in this series are comparable to the best performing THA in equivalent registry data. Instability was the leading cause of revision but these data did not identify a causative factor. The changes in infection rate in this series are possibly influenced by changes in local antibiotic prophylaxis policy. There is a learning curve for the cementless stem as seen here by a reduction in revisions for aseptic loosening and iatrogenic femoral fracture during the ten-year period. We believe that collared stems, avoidance of undersizing and surgical technique focusing on primary stability are the key aspects


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 25 - 25
1 Mar 2017
Mitsui H Sugimoto K Sakamoto M
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Introduction. Achieving primary and long-term stability of femoral implant is critical for THA. This can be influenced by the shape and location of surface preparation as well as geometry. The Corail® stem has developed in 1986 in France, which is a straight quadrangular, and full HA coated standard titanium alloy stem featuring a metaphyseal tulip flare in combination with horizontal and vertical grooves. We have performed 75 THAs using it since May 2013. The purpose of this study was to evaluate radiographic changes of femur over time in Japanese patients after THA using this HA coated stem. Materials and Methods. Between May 2013 and September 2015, we implanted 75 THAs using a Corail® stem (DePuy-Synthes) in 66 patients. Their ages at operation were 47 to 93 years (avg. 66.5 years). Durations of follow up were 6 to 34 months after implantation (avg. 13.7 months). Acetabular components were standard titanium alloy, either 37 Pinnacle Porocoat®, 19 Pinnacle Gription® (DePuy-Synthes), 8 Ranawat®, 5 Regenerex®, or 6 G7® (Zimmer-Biomet) uncemented cups. Heads were either 73 BIOLOX delta® ceramic (CeramTec) or 2 CoCr. Liners were either 56 Marathon® (DePuy-Synthes) or 19 E1® HXLPE (Zimmer-Biomet). We studied 74 hips except one hip which was revised due to infection at the time of 3 weeks after surgery. Postoperative radiographic evaluations were done at the time of 2, 4, 6, 9, 12 months and then every 6 months thereafter. We examined cancellous condensation, radiolucent line, osteolysis, cortical hypertrophy and stress shielding using both of plain X-ray and Tomosynthesis (Shimadzu, Japan). Results. The stem size included #8 in two hips, #9 in seven hips, #10 in eleven hips, #11 in twenty three hips, #12 in thirteen hips, #13 in ten hips, #14 in seven hips and #15 in one hip. Four periprosthetic fractures occurred during surgery. There were three subsidences in combination with radiolucent line at Gruen Zone 1 (Fig. 1, 2 and 3). The cancellous condensation was observed in 25% of all at the time of 2 months, 63% at 4 months, 87% at 6 months and 100% at 9 months after surgery at Gruen Zone 2, 3, 5 and 6 (Fig. 4, 5 and 6). At the latest follow-up, osteolysis, cortical hypertrophy and stress shielding were no evident in each hip. Discussion. Primary stability of the Corail® stem must be achieved in a bed of cancellous bone. ARTRO group recommends that the correct size is the size that fills the femoral cavity to within 1 to 2mm distance from the cortices in templating process. We followed this indication intraoperatively in early days, but we experienced three subsided cases that might be caused by this indication. In present, we emphasize to gain the surgical tip to feel both axial and rotational stability by the final broach rather than the indication in templating process. Radiological appearance of the remaining cancellous bed shows 0.5 to 1mm distance from the cortices and we don't have any stem subsidence after we changed out previous surgical technique