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Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_9 | Pages 7 - 7
1 Aug 2015
Carsi M Clarke N
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This retrospective matched cohort study tested the hypothesis that an incomplete periacetabular acetabuloplasty, as an added step to delayed open reduction, diminishes the risk of developing acetabular dysplasia.

29 hips from 23 patients with idiopathic DDH that underwent intentionally delayed open reduction and acetabuloplasty at our institution from 2003 to 2010 were matched for age at presentation and bilaterality to historic controls. These were 29 hips from 26 patients, treated with open reduction alone from 1989 to 2003. Residual dysplasia treated with pelvic osteotomy, AVN grade II-IV, and rate of re-intervention were the outcome measures.

The mean ages at diagnosis and at surgery were 8.62 weeks and 12.97 months, respectively. At latest follow-up, 27 hips in the acetabuloplasty group and 22 in the open reduction alone group had satisfactory radiographic outcome (Severin class Ia, Ib or II) (p=0.16). 18 of the 58 hips (31.0%) had AVN, 7 (24.14%) in the case group and 11(37.93%) in the control group. Further surgery was required in 15 of the 29 hips in the open reduction alone group. These included 2 revision of open reductions, 5 pelvic osteotomies, 3 varus derotation osteotomies, and 5 apo or epiphysiodesis whilst only one patient in the acetabuloplasty group required a medial screw epiphysiodesis for late lateral growth arrest. There is a positive association between the need for further surgery and open reductions alone: the odds ratio is 14.00 and the 95% confidence interval (1.97, 99.63), p=0.0017. The five hips in the open reduction alone group that required a pelvic osteotomy were intervened at an average of 31.45 (±9.07) months.

The addition of an incomplete periacetabular periacetabuloplasty to all hips undergoing open reduction eliminated residual acetabular dysplasia in this cohort whilst it does not appear to have deleterious effects, as evidenced by the similar Severin and McKay scores.


Bone & Joint 360
Vol. 4, Issue 3 | Pages 35 - 36
1 Jun 2015
Clarke A


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_8 | Pages 13 - 13
1 Jun 2015
Ramakrishna S Leslie D Vijayaraghavan J Clarke H
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Corail implants have shown to give good results in elective total hip replacements (THR) and in hemi-arthroplasties. Pre-operative planning to identify the correct size of the Corail implant is vital for good post-operative outcomes. An undersized implant can lead to subsidence. The aim of the study was to review the incidence of subsidence. Post-operative radiographs of trauma patients (n=39) and elective (n=45) patients who had Corail femoral implants were reviewed. The implant-to-canal (I:C) ratio were calculated at the given 50% and 70% levels of the Corail implant. Follow up radiographs were reviewed to identify subsidence. The average age of patients was 80.3 years (range 66–93 years) in hemi-arthroplasties and 61 years (range 18–88) in elective THRs. The implant to canal (I:C) ratio at the 50% and 70% levels in trauma patients were 0.77 (range 0.54 – 0.97) and 0.81 (range 0.59 – 0.94) respectively. In elective patients, the ratios at the 50% and 70% marks were 0.77 (range 0.57 – 0.98) and 0.81 (0.56 – 0.95). One case of subsidence was seen in a collarless implant and I:C ratios at 50% and 70% were 0.57 and 0.56. A larger study is required to determine the reliability of this novel ‘implant:canal’ ratio to predict incidence.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_3 | Pages 2 - 2
1 Apr 2015
Hansom D Ramage G Burgess K Gadengaard N Millar N Clarke J
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The most common bacteria in orthopaedic prosthetic infections are Staphylococcus, namely Staphylococcus Epidermidis (SE) and Staphylococcus Aureus (SA). Infection causes implant failure due to biofilm production. Biofilms are produced by bacteria once they have adhered to a surface.

Nanotopography has major effects on cell behaviour. Our research focuses on bacterial adhesion and biofilm formation on nanofabricated materials. Bacteria studied were clinically relevant from an orthopaedic perspective, SA and SE. We hypothesise that that nanosurfaces can modulate bacterial adherence and biofilm formation and may reduce orthopaedic implant infection rate.

Isolated bacteria were grown and growth conditions optimised. Bacterial concentrations were calculated by using qPCR. Statistical analysis allowed identification of optimal biofilm growth conditions. These were refined on standard, non-nanopatterned surfaces, and then control and nanopatterned polystyrene (nanopits) and titanium plates (nanowires). Adhesion analysis was performed using fluorescence imaging and quantitative PCR.

4 bacterial strains were isolated and cultured. Growth kinetics based on 24hr cultures allowed isolation of optimal media for biofilm conditions (Dulbecco's Modified Eagle Medium with additional supplements). Highest bacterial concentrations were found following 2hrs incubation with Lysozyme during qPCR. Bacterial concentration significantly increased between 30, 60 and 90 minutes incubation. Differences in percentage coverage on different polysyrene nanosurfaces (nanopits) were noted varying. This was confirmed by qPCR extractions that showed different bacterial concentrations on different nanopatterns. Titanium nanowire surfaces significantly increased bacterial adhesion (P<0.05).

Our study cultured and quantified bacterial biofilm and suggests that by altering nanotopography, bacterial adhesion and therefore biofilm formation can be affected. Specific nanopatterned surfaces may reduce implant infection associated morbidity and mortality. Clearly this is of significant benefit to the patient, the surgeon and the NHS, and may well extend far beyond the realms of orthopaedics.


The Bone & Joint Journal
Vol. 97-B, Issue 4 | Pages 449 - 457
1 Apr 2015
Pulikottil-Jacob R Connock M Kandala N Mistry H Grove A Freeman K Costa M Sutcliffe P Clarke A

Many different designs of total hip arthroplasty (THA) with varying performance and cost are available. The identification of those which are the most cost-effective could allow significant cost-savings. We used an established Markov model to examine the cost effectiveness of five frequently used categories of THA which differed according to bearing surface and mode of fixation, using data from the National Joint Registry for England and Wales. Kaplan–Meier analyses of rates of revision for men and women were modelled with parametric distributions. Costs of devices were provided by the NHS Supply Chain and associated costs were taken from existing studies. Lifetime costs, lifetime quality-adjusted-life-years (QALYs) and the probability of a device being cost effective at a willingness to pay £20 000/QALY were included in the models.

The differences in QALYs between different categories of implant were extremely small (<  0.0039 QALYs for men or women over the patient’s lifetime) and differences in cost were also marginal (£2500 to £3000 in the same time period). As a result, the probability of any particular device being the most cost effective was very sensitive to small, plausible changes in quality of life estimates and cost.

Our results suggest that available evidence does not support recommending a particular device on cost effectiveness grounds alone. We would recommend that the choice of prosthesis should be determined by the rate of revision, local costs and the preferences of the surgeon and patient.

Cite this article: Bone Joint J 2015;97-B:449–57.


Bone & Joint Research
Vol. 4, Issue 3 | Pages 29 - 37
1 Mar 2015
Halim T Clarke IC Burgett-Moreno MD Donaldson TK Savisaar C Bowsher JG

Objectives

Third-body wear is believed to be one trigger for adverse results with metal-on-metal (MOM) bearings. Impingement and subluxation may release metal particles from MOM replacements. We therefore challenged MOM bearings with relevant debris types of cobalt–chrome alloy (CoCr), titanium alloy (Ti6Al4V) and polymethylmethacrylate bone cement (PMMA).

Methods

Cement flakes (PMMA), CoCr and Ti6Al4V particles (size range 5 µm to 400 µm) were run in a MOM wear simulation. Debris allotments (5 mg) were inserted at ten intervals during the five million cycle (5 Mc) test.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_2 | Pages 23 - 23
1 Feb 2015
Davis N Hourigan P Challinor H Clarke A
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Purpose of study and background

The use of NRB (Nerve Root Block) in radicular pain caused by stenosis is considered controversial in some centres, whereas its indication in radiculitis caused by disc herniation is widely accepted. Most studies evaluating NRB have combined disc herniation and stenosis pathologies in their inclusion criteria. This study explores the efficacy of NRB in different categories of stenosis: lateral recess, foraminal and combined.

Methods and results

68 patients underwent NRB by an ESP (Extended Scope Physiotherapist). 37 females, 31 males, mean age 75 years (range 23–87). Their stenosis was categorized as either lateral recess (n=43), foraminal (n=18), or combined (n=7) on MRI scan evaluation by 2 reviewers. Roland Morris Disability Questionnaire and Visual Analogue Scores were recorded pre-injection and 6 weeks post injection. 2 year final outcome was recorded with an ‘in-house’ questionnaire.

2 year outcome: Lateral recess stenosis: 37% had surgery, 40% required no further treatment. In foraminal stenosis: 17% had surgery, 50% required no further treatment. Combined pathology: 43% had surgery, 57% required no further treatment. Patients requiring no further treatment rated their 2 year outcome as satisfactory symptom control. Of the whole group 15% required a repeat injection, 7% were referred to pain clinic and one patient had died.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_15 | Pages 22 - 22
1 Oct 2014
Meakin J Hopkins S Clarke A
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The objective of this study was to assess the reliability and appropriateness of statistical shape modelling for capturing variation in thoracic vertebral anatomy for future use in assessing scoliotic vertebral morphology.

Magnetic resonance (MR) images of the thoracic vertebrae were acquired from 20 healthy adults (12 female, 8 male) using a 1.5 T MR scanner (Intera, Philips). A T1 weighted spin-echo sequence (repetition time = 294 ms, echo time = 8 ms, number of signal averages = 3) was used. A set of slices (number = 27, thickness = 1.9 mm, gap = 1.63 mm, pixel size = 0.5 mm) were acquired for each vertebrae, parallel to the mid-transverse plane of the vertebral body. Repeated imaging, including participant repositioning, was performed for T4, T8 and T12 to assess reliability. Landmark points were placed on the images to define anatomical features consisting of the vertebral body and foramen, pedicles, transverse and spinous processes, inferior and superior facets. A statistical shape model was created using software tools developed in MATLAB (R2013a, The MathWorks Inc.). The model was used to determine the mean vertebral shape and ‘modes of variation’ describing patterns in vertebral shape. Analysis of variance was used to test for differences between vertebral levels and subjects and reliability was assessed by determining the within-subject standard deviation from the repeated measurements.

The first three modes of variation, shown below (green = mean, red and blue = ±2 standard deviations about the mean), accounted for 70% of the variation in thoracic vertebral shape (Mode 1 = 44%, Mode 2 = 19%, Mode 3 = 4%). Visual inspection indicated that these modes described variation in anatomical features such as the aspect ratio of the vertebral bodies, width and orientation of the pedicles, and position and orientation of the processes and facet points. Variation in shape along the thoracic spine, characterised by these modes of variation, was consistent with that reported in the literature. Significant differences (p< 0.05) between vertebral levels and between some subjects were found. The reliability of the method was good with low relative error (Mode 1 = 5%, Mode 2 = 8%, Mode 3 = 19%).

Statistical shape modelling provides a reliable method for characterizing many anatomical features of the thoracic vertebrae in a compact number of variables. This is useful for robustly assessing morphological differences between scoliotic and non-scoliotic vertebrae and in assessing entry points and trajectories for pedicle screws.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_9 | Pages 20 - 20
1 May 2014
Dawkins C Diament M Clarke A Shahban S Eardley W Port A
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Commissioning for quality and innovation (CQUIN) guidelines specify that diaphyseal fractures of the tibia should be treated within 24 hours of admission. We aimed to identify our compliance at a Major Trauma Centre.

Restrospective analysis of all tibia fractures over 12 months. Fractures that were not diaphyseal nor open were excluded. Time of presentation, x-ray, arrival to ward and arrival in theatre were analysed against CQUIN guidelines.

43 fractures, 18 (42%) arrived in theatre for operative management within 24 hours. 15 (35%) were managed operatively in the subsequent 24 hours and 10 (23%) were managed after 48 hours. Average time to theatre was 38 hrs 37 mins (SD 29hrs 42mins). It took on average 51mins (SD 43 mins) for a patient to have an xray and 3 hrs 53 mins (SD 1hr 47mins) to arrive on the ward, and average 3 hrs 2 mins (SD 1hr 43mins) between xray and the ward.

42% of patients are making CQUIN standards for closed tibial shaft fractures. There are logistical and resource factors contributing towards this as well as clinical issues. To address this there needs to be an agreed multidisciplinary pathway developed to ensure compliance with CQUIN standards.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 31 - 31
1 Feb 2014
Underwood M Sutcliffe P Connock M Shyangdan D Court R Ngianga-Bakwin K Clarke A
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Study Purpose

To review systematically review literature on the early diagnosis of spinal metastases and prediction of spinal cord compression (SCC) due to spinal metastases

Methods and results

From 13 electronic bibliographic databases were searched we identified 2,425 potentially relevant articles of which 31 met the inclusion criteria. These were quality appraised. Seventeen studies reported retrospective data, 10 were prospective studies, and three were other study designs. There was one systematic review. There were no randomised controlled trials. There were approximately 7,900 participants in the included studies and 5,782 participants were analysed. The sample sizes ranged from 41 to 859. Cancers reported were: lung alone (n=3); prostate alone (n=6); breast alone (n=7); mixed cancers (n=13); and unclear (n=1). Ninety-three prognostic factors were identified as potentially significant in predicting risk of SCC or collapse. Many of the included studies provided limited information about patient population and selection criteria and they varied in methodological quality, rigour and transparency. Several studies with mixed case populations identified type of cancer (e.g. breast, lung or prostate cancer) as a significant factor in predicting SCC, but determining the risk differential is difficult because of residual bias in studies. Overall the quality of the research was poor. The only predictors identified for SCC were number of spinal metastases, duration of disease, total disease burden and immediate symptomatology of cord involvement.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_1 | Pages 2 - 2
1 Jan 2014
Ahmad M Acharya M Clarke A Fernandes J Jones S
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Aim

To determine the rate of recurrence of coronal plane deformity in children treated with ‘guided growth’ using 8-plates, from the time of implant removal to skeletal maturity.

Methods

Over a consecutive 5 year period between April 2008 and April 2013 we analysed our results of guided growth treatment using 8-plates to correct coronal plane lower limb deformity. Patients with neuromuscular disorders such as cerebral palsy were excluded.

Deformity planning was performed using standardised techniques.

Our standard practice is to remove the 8-plate and screws once deformity is corrected both clinically and radiologically. Patients were followed up until either skeletal maturity or recurrence, which necessitated reapplication of the 8-plate.

We are aware of no study in which children treated with guided growth using 8-plates are followed up to skeletal maturity.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_1 | Pages 7 - 7
1 Jan 2014
Al-Naser S Judd J Clarke NMP
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Femoral head deformity can be a devastating outcome in a small percentage of patients with Perthes' disease. Deformities usually start during the fragmentation stage. In this study, we aimed to determine the effects of Vitamin D deficiency on the natural history of Perthes' disease.

Patients with Perthes' disease and Vitamin D deficiency presenting to our unit in the last 3 years were identified. All X-rays were reviewed retrospectively to determine the duration of the fragmentation and ossification stages. Treatment methods were obtained from the notes. Late presenters (i.e. after fragmentation stage) were excluded.

In our unit, Vitamin D deficiency is diagnosed if levels <72 nmol/L. Fifteen patients (17 hips) with Perthes' disease were found to be Vitamin D deficient. Levels ranged from (18–71 nmol/L). The mean length of the fragmentation stage was 15.7 months which is significantly higher than quoted literature figures (8 months). Ossification stage duration was 18.8 months which was comparable to quoted figures. However, patients with severe Vitamin D deficiency (< 52 nmol/L) were found to have longer ossification stage (20.6 months) compared with patients with mild deficiency (52–72 nmol/L) (16.4 months). Seven out of 16 patients (44%) required surgical containment which is significantly higher than the usually low rates of surgical intervention.

The critical fragmentation stage in Vitamin D deficiency is significantly longer putting the femoral head at higher risk of deformity and extrusion. This leads to higher rates of surgical containment. Also the severity of Vitamin D deficiency might be an important determinant of the period of time required for ossification and healing.

Vitamin D level is an important prognostic factor and must be measured in all patients with Perthes' disease. Prescribing Vitamin D supplements is advisable in this group of patients. However, the effects of these supplements on the course of the disease requires further research.

Level of evidence: III


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 256 - 256
1 Dec 2013
Burgett M Clarke I Donaldson T Halim T
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The relevance of fluid-film lubrication, elasto-hydrodynamic lubrication and ‘tribolayers’ for hip bearings has been the subject of much debate (Fisher 2012). However, knowledge of the thickness and distribution of proteins in and around the wear zone of metal-on-polyethylene (MPE) bearings is scant. The efficacy of protein lubrication with metal-on-metal bearings (MOM) is in discovery. This simulator study was designed to analyze film formation on MOM bearings using varied protein concentrations. The hypotheses were that increasing protein concentrations in the serum lubricant would result in 1) greater thickness of protein films, and 2) reduced MOM wear.

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

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

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

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

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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 265 - 265
1 Dec 2013
Clarke I Lazennec JY Brusson A Burgett M Donaldson T
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This study of retrieved 28 mm Metasul™ (cemented) revealed for the first time adverse wear effects created by impingement-subluxation in MOM. The 10 cases selected (with femoral stems) had annual follow-up 3–11 years. (1) Unequivocal evidence here shows that all heads routinely subluxed from the Metasul liners.

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

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

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

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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 451 - 451
1 Dec 2013
Nguyen D Burgett M Clarke I Halim T Donaldson T
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Damage to metal-on-metal bearings (MOM) has been varyingly described as “edge wear,” third-body abrasive wear and “rim-damage” (1–4). However, no distinction has been made between any of these proposed wear mechanisms. The goal of this study was to discover what features might differentiate between surface damage created by either 2-body or 3-body wear mechanisms in MOM bearings. The hypotheses were that surface damage created by impingement of the cup rim (2-body wear) would be i) linear on the micro-scale, ii) reveal transverse striations (in direction of the sliding rim), iii) have either no raised lip or have a single lip along one side of the track, and iv) have an asymmetrical surface profile across the track width.

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

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

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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 117 - 117
1 Dec 2013
Clarke I Lazennec JY Brusson A Burgett M Donaldson T
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Controversy exists over the role of fretting-corrosion in modular junctions of large-diameter metal-on-metal (MOM) heads given the many design plus alloy mix-and-match variations. Overall data was also scant regarding a) fitting stem trunnions to head tapers, b) role of taper angles, c) role of smooth vs threaded trunnion junctions, d) role of head neck-lengths and e) role of head diameters. While the “12: 14” taper has been used with small CoCr heads for 40 years, we could not find retrieval analyses on this European ‘gold-standard’. We therefore selected 10 femoral stems with 28 mm modular heads for analysis (3–8 years follow-up). Unique to this study were the threaded taper profiles on both stems and heads (Fig. 1).

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

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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 420 - 420
1 Dec 2013
McPherson E Burgett M Halim T Donaldson T Clarke I
Full Access

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

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

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

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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 152 - 152
1 Dec 2013
Pour AE Lazennec JY Brusson A Rousseau M Clarke I
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Introduction

Accurate evaluation of femoral offset is difficult with conventional anteroposterior (AP) X-rays. Routine CT imaging is costly and exposes patients to a significant dose of radiation. The EOS® imaging system is an innovative slot-scanning radiography system that makes possible the acquisition of simultaneous and orthogonal AP and lateral images of the patient in standing position. These 2-dimensional (2D) images are equivalent to standard plane X-rays. Three-dimension (3D) reconstructions are obtained from these paired images according to a validated protocol. This prospective study explores for the first time the value of the EOS® imaging system for comparing measurements of femoral offset obtained from 2D images and 3D reconstructions.

Materials and Methods

Following our standard protocol, we included a series of 100 patients with unilateral total hip arthroplasty (THA). The 2D offset was measured on the AP view with the same protocol as for standard X-rays. The 3D offset was calculated from the reconstructions based on the orthogonal AP and lateral views. Reproducibility and repeatability studies were conducted for each measurement. We compared the 2D and 3D offsets for both hips (with and without THA).


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 340 - 340
1 Dec 2013
Halim T Burgett M Clarke I Donaldson T
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It has come to light that one significant mechanism for MOM failure may be repeated subluxation or impingement episodes leading to edge wear and release of 3rd body particles. This MOM debris-challenge model simulates a patient who experienced one subluxation or impingement event and then continues to walk normally until the next event occurs one week later. Our model assumes that 100–200 particles (debris size 100–200 μm) would be released into the joint space at each subluxation or impingement event. The question then becomes: what is the effect of the patient walking on that single dose of particulates over the next week (or 500,000 cycles in simulator test mode).

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

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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 391 - 391
1 Dec 2013
Lazennec JY Brusson A Ebramzadeh E Clarke I
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Unlike conventional radiographic methods, the newly introduced EOS system provides simultaneously-synchronized anteroposterior (AP) and true-lateral (LAT) x-ray images. EOS offers considerable potential for calculating parameters such as true femoral and acetabular angular positioning, impingement sites, and also for measuring wear in polyethylene cups. In this study we used THA wear-simulation fixtures to assess 3D-wear in polyethylene cups using EOS algorithms.

Material and methods

A validated phantom apparatus was used to simulate values of three-dimensional wear, controlled in the 3 directions (antero-posterior, medio-lateral, cranio-caudal) using micrometers. (Figure 1)

24 simulations of wear with controlled amplitudes and directions were imaged using the biplane EOS slot-scanning system. Wear amplitudes were between 0 and 3464 μm. Using dedicated software, wear was measured by a 2D/3D matching of 3D spheres onto the 2D frontal and lateral radiographs, allowing the determination of the 3D coordinates of both the cup and femoral head centers and thus the calculation of a 3D wear vector. (Figure 2)

Measured wear vector were compared to real wear vectors in terms of amplitude and direction.3D wear vectors were measured twice by 3 independent observers (for a total of 144 measurements) in order to evaluate intra- and inter-observer reliability.

Results

There was a strong correlation between the measured wear amplitude and the real wear amplitude (Pearson's r = 0,99). Mean error when comparing wear measurement amplitude with real wear amplitude was 356 μm (SD = 127 μm). None of the 144 measurements presented an error over 1 mm.

The accuracy of wear direction evaluation was highly correlated with wear amplitude (Spearman's rho = 0,98), the measurement of 3D wear direction presenting an accuracy better than 15° for wear amplitudes over 1,5 mm. Intra-observer errors for wear amplitude were between 138 μm and 221 μm depending on the observer. Inter-observer error for wear amplitude was 333 μm.