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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 94 - 94
23 Feb 2023
Grupp T Schierjott R Pfaff A Tozzi G Schwiesau J Giurea A
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Total knee arthroplasty with a rotating hinge knee with carbon-fibre-reinforced (CFR)-PEEK as an alternative bushing material with enhanced creep, wear and fatigue behaviour has been clinically established [1-4]. The objective of our study was to compare results from in vitro biotribological characterisation to ex vivo findings on a retrievals. A modified in vitro wear simulation based on ISO 14243-1 was performed for 5 million cycles on rotating hinge knee (RHK) designs (EnduRo®) out of cobalt-chromium and ZrN-multilayer ceramic coating. The rotational & flexion axles-bushings and the flanges are made of CFR-PEEK with 30% polyacrylonitrile fibre content. Analysis of 12 retrieved EnduRo® RHK systems in cobalt-chromium and ZrN-multilayer in regard to loosening torques, microscopic surface analysis, distinction between different wear modes and classification with a modified HOOD-score has been performed. For the RHK design with the polyethylene gliding surface and bushings and flanges made out of CFR-PEEK, a cumulative volumetric wear was measured to be 12.9±3.95 mm. 3. in articulation to cobalt-chromium and 1.3±0.21 mm. 3. to ZrN-multilayer coating - a significant 9.9-fold decrease (p=0.0072). For the CFR-PEEK flexion bushing and flanges the volumetric wear rates were 2.3±0.48 mm. 3. /million cycles (cobalt-chromium) and 0.21±0.02 mm. 3. /million cycles (ZrN-multilayer) (p=0.0016). The 5 million cycles of in vitro wear testing reflect a mean in vivo service life of 2.9 years, which is in accordance to the time in vivo of 12–60 months of the retrieved RHK components [5]. The main wear modes were comparable between retrievals and in vitro specimens, whereby the size of affected area on the retrieved components showed a higher variation. For the EnduRo® RHK design the findings on retrieved implants demonstrate the high suitability of CFR-PEEK as a biomaterial for highly loaded bearings, such as RHK bushings and flanges in articulation to cobalt-chromium and to a ZrN-multilayer coating


Bone & Joint Research
Vol. 7, Issue 7 | Pages 476 - 484
1 Jul 2018
Panagiotopoulou VC Davda K Hothi HS Henckel J Cerquiglini A Goodier WD Skinner J Hart A Calder PR

Objectives. The Precice nail is the latest intramedullary lengthening nail with excellent early outcomes. Implant complications have led to modification of the nail design. The aim of this study was to perform a retrieval study of Precice nails following lower-limb lengthening and to assess macroscopical and microscopical changes to the implants and evaluate differences following design modification, with the aim of identifying potential surgical, implant, and patient risk factors. Methods. A total of 15 nails were retrieved from 13 patients following lower-limb lengthening. Macroscopical and microscopical surface damage to the nails were identified. Further analysis included radiology and micro-CT prior to sectioning. The internal mechanism was then analyzed with scanning electron microscopy and energy dispersive x-ray spectroscopy to identify corrosion. Results. Seven male and three female patients underwent 12 femoral lengthenings. Three female patients underwent tibial lengthening. All patients obtained the desired length with no implant failure. Surface degradation was noted on the telescopic part of every nail design, less on the latest implants. Microscopical analysis confirmed fretting and pitting corrosion. Following sectioning, black debris was noted in all implants. The early designs were found to have fractured actuator pins and the pin and bearings showed evidence of corrosive debris. The latest designs showed evidence of biological deposits suggestive of fluid ingress within the nail but no corrosion. Conclusion. This study confirms less internal corrosion following modification, but evidence of titanium debris remains. We recommend no change to current clinical practice. However, potential reuse of the Precice nail, for secondary limb lengthening in the same patient, should be undertaken with caution. Cite this article: V. C. Panagiotopoulou, K. Davda, H. S. Hothi, J. Henckel, A. Cerquiglini, W. D. Goodier, J. Skinner, A. Hart, P. R. Calder. A retrieval analysis of the Precice intramedullary limb lengthening system. Bone Joint Res 2018;7:476–484. DOI: 10.1302/2046-3758.77.BJR-2017-0359.R1


Bone & Joint Research
Vol. 6, Issue 5 | Pages 345 - 350
1 May 2017
Di Laura A Hothi H Henckel J Swiatkowska I Liow MHL Kwon Y Skinner JA Hart AJ

Objectives. The use of ceramic femoral heads in total hip arthroplasty (THA) has increased due to their proven low bearing wear characteristics. Ceramic femoral heads are also thought to reduce wear and corrosion at the head-stem junction with titanium (Ti) stems when compared with metal heads. We sought to evaluate taper damage of ceramic compared with metal heads when paired with cobalt chromium (CoCr) alloy stems in a single stem design. Methods. This retrieval study involved 48 total hip arthroplasties (THAs) with CoCr V40 trunnions paired with either CoCr (n = 21) or ceramic (n = 27) heads. The taper junction of all hips was evaluated for fretting/corrosion damage and volumetric material loss using a roundness-measuring machine. We used linear regression analysis to investigate taper damage differences after adjusting for potential confounding variables. Results. We measured median taper material loss rates of 0.210 mm. 3. /year (0.030 to 0.448) for the metal head group and 0.084 mm. 3. /year (0.059 to 0.108) for the ceramic group. The difference was not significant (p = 0.58). Moreover, no significant correlation between material loss and implant or patient factors (p > 0.05) was found. Conclusions. Metal heads did not increase taper damage on CoCr trunnions compared with ceramic heads from the same hip design. The amount of material released at the taper junctions was very low when compared with available data regarding CoCr/Ti coupling in metal-on-metal bearings. Cite this article: A. Di Laura, H. Hothi, J. Henckel, I. Swiatkowska, M. H. L. Liow, Y-M. Kwon, J. A. Skinner, A. J. Hart. Retrieval analysis of metal and ceramic femoral heads on a single CoCr stem design. Bone Joint Res 2017;6:–350. DOI: 10.1302/2046-3758.65.BJR-2016-0325.R1


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 85 - 85
1 Apr 2019
Dall'Ava L Hothi H Henckel J Cerquiglini A Laura AD Shearing P Hart A
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Introduction. The use of Additive Manufacturing (AM) to 3D print titanium implants is becoming widespread in orthopaedics, particularly in producing cementless porous acetabular components that are either custom-made or off-the-shelf; the primary design rationale for this is enhanced bony fixation by matching the porosity of bone. Analysis of these retrieved components can help us understand their performance; in this study we introduce a non-destructive method of the retrieval analysis of 3D printed implants. Material and methods. We examined 11 retrieved 3D printed acetabular cups divided into two groups: “custom-made” (n = 4) and “off-the-shelf” (n = 7). A macroscopic visual analysis was initially performed to measure the area of tissue ongrowth. High resolution imaging of each component was captured using a micro-CT scanner and 3D reconstructed models were used to assess clinically relevant morphometric features of the porous structure: porosity, porous structure thickness, pore size and strut thickness. Optical microscopy was also used as a comparison with microCT results. Surface morphology and elemental composition of the implants were investigated with a Scanning Electron Microscope (SEM) coupled with an Energy Dispersive X-ray Spectroscope (EDS). Statistical analysis was performed to evaluate possible differences between the two groups. Results. We found a spread of tissue coverage, median of 81% (23 – 95), with a trend with time in situ. Custom implants showed a higher spread of porosity, with median value of 74.11% (67.94 – 81.01), due to the presence of differently designed porous areas. Off-the-shelf cups had median porosity of 72.49% (66.67 – 73.07), but there was no significant difference between the two groups (p = 0.164). There was a significant difference in the thickness of the porous structure of the two groups, which were 3.918 mm (3.688 – 4.102) and 1.289 mm (1.235 – 1.364), respectively (p = 0.006). SEM output showed specific morphological features of 3D printed object; EDS analysis suggested that no chemical modifications occurred in vivo, with elemental ratios (Ti/Al = 14; Ti/V = 21; Al/V = 1.51) comparable to previously published results. Conclusion. This is one of the first retrieval studies of 3D printed orthopaedic implants. We introduced a method for the investigation of these components and micro-CT scanning enabled the non-destructive assessment of the porous structure. This work represents the first step in understanding the performance of 3D printed implants


Bone & Joint Research
Vol. 2, Issue 9 | Pages 200 - 205
1 Sep 2013
Amarasekera HW Campbell PC Parsons N Achten J Masters J Griffin DR Costa ML

Objectives . We aimed to determine the effect of surgical approach on the histology of the femoral head following resurfacing of the hip. Methods. We performed a histological assessment of the bone under the femoral component taken from retrieval specimens of patients having revision surgery following resurfacing of the hip. We compared the number of empty lacunae in specimens from patients who had originally had a posterior surgical approach with the number in patients having alternative surgical approaches. Results. We found a statistically significant increase in the percentage of empty lacunae in retrieval specimens from patients who had the posterior approach compared with other surgical approaches (p < 0.001). . Conclusions. This indicates that the vascular compromise that occurs during the posterior surgical approach does have long-term effects on the bone of the femoral head, even if it does not cause overt avascular necrosis. Cite this article: Bone Joint Res 2013;2:200–5


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 132 - 132
1 Feb 2017
MacDonald D Chen A Lee G Klein G Cates H Mont M Rimnac C Kurtz S
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Introduction. During revision surgery with a well-fixed stem, a titanium sleeve can be used in conjunction with a ceramic head to achieve better stress distribution across the taper surface. Previous studies have observed that the use of a ceramic head can mitigate the extent of corrosion damage at the taper. Moreover, in vitro testing suggests that corrosion is not a concern in sleeved ceramic heads [1]; however, little is known about the in vivo fretting corrosion of the sleeves. The purpose of this study was to investigate fretting corrosion in sleeved ceramic heads. Materials and Methods. Thirty sleeved ceramic heads (Biolox Option: CeramTec) were collected during revision surgery as part of a multi-center retrieval program. The sleeves were used in conjunction with a zirconia-toughened alumina femoral head. The femoral heads and sleeves were implanted between 0.0 and 3.25 years (0.8±0.9, Figure 1). The implants were revised predominantly for instability (n=14), infection (n=7), and loosening (n=5). Fifty percent of the retrievals were implanted during a primary surgery, while 50% had a history of a prior revision surgery. Fretting corrosion was scored using a previously described 4-point, semi-quantitative scoring system proposed by Higgs [2]. Results. Among the sleeved ceramic heads, mild-to-moderate fretting corrosion scores (Score = 2–3) were observed in 96% of internal tapers, 26% of external tapers, and 82% of the stems. On the internal taper surface, 5 sleeves had moderate fretting corrosion data (Score = 3, Figure 2). None of sleeves had severe (Score = 4) at any taper surface. Fretting corrosion scores were higher at the internal taper surface than the external taper. Implantation time was the main predictor of increased fretting-corrosion of the external sleeve tapers. Discussion. For the sleeved ceramic heads, we found that fretting corrosion can occur in these components, particularly on the internal surface of the sleeve. However, the fretting corrosion scores were predominantly mild, and lower than fretting scores of CoCr heads in metal on polyethylene bearings. Because the sleeves are Ti alloy, the corrosion products are considered to be less cytotoxic than Co and Cr. The primary limitation to this study is the short-term follow-up of these retrievals. As the fretting corrosion process is often associated with in vivo duration, future studies with longer-term implants are necessary to elucidate the long-term performance of these devices


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 203 - 203
1 Jul 2014
Rowell S Muratoglu O
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Summary. Fifteen irradiated, vitamin E-diffused UHMWPE retrievals with up to three years in vivo service showed no appreciable oxidation, nor change in material properties from a never-implanted liner, and showed a 94% decrease in free radical content. Introduction. Radiation cross-linking, used to improve wear resistance of ultra-high molecular weight polyethylene (UHMWPE) bearings used in total joint arthroplasty, generates residual free radicals which are the precursors to oxidative embrittlement. First generation materials adopted thermal treatments to eliminate or reduce free radical content, but came with compromises in reduced mechanical properties or insufficient stabilization. A second generation alternative method infuses an antioxidant, vitamin E, into irradiated UHMWPE to stabilise free radicals while maintaining fatigue strength. In vitro studies predict excellent oxidation and wear resistance in vitamin E-stabilised bearings, but the long-term in vivo oxidation behavior, influenced by lipid absorption and cyclic loading, remains largely unknown. Our aim was to investigate in vivo changes in UHMWPE surgically-retrieved explants that were radiation cross-linked and stabilised by vitamin E. Patients & Methods. Fifteen surgically-retrieved irradiated, vitamin E-diffused and inert-gamma sterilised bearings (E1™, Biomet, Inc., Warsaw IN) with in vivo durations ranging from 3 days to 36.6 months were analyzed at unloaded rim/eminence and the articular surface along with one never-implanted component. Total lifetime of components was summed as shelf storage prior to implantation, in vivo duration and ex vivo duration in air. Fourier Transform Infrared Spectroscopy (FTIR) was used to measure carbonyl index (CI; per ASTM F2102-01ε1) both before and after 16 hour hexane extraction to. Extracted thin films were also reacted with nitric oxide to quantify hydroperoxides, an intermediate oxidation product associated with oxidation potential. Cross-link density was calculated from gravimetric swelling analysis per ASTM F2214. Crystallinity measurements were performed regionally using differential scanning calorimetry (DSC). Free radical content was measured by electron spin resonance (Memphis, TN). Results. Irradiated and vitamin E-diffused retrievals showed scratching at the articular surface, but retained machining marks up to three years in vivo, indicative of no measurable wear. Retrievals showed no significant oxidation at the time of surgical removal with maximum post-hexane carbonyl indices in the barely detectable range (MCI=0.029–0.154), located at the surface of retrievals. Ex vivo oxidation was not observed after 18 months of aging in air at room temperature. There was no increase in hydroperoxides (never-implanted HI=0.62±0.04; retrieval HI= 0.62±0.04), nor change in cross-link density (never-implanted: 0.275±0.015 mol/dm. 3. ; retrieval: 0.295±0.016 mol/dm. 3. ) or crystallinity (never-implanted: 58.3±1.4%; retrievals: 60.0±3.5%). Lipid penetration increased with time, showing a higher rate of diffusion in loaded regions. Free radical content was observed to decay with increasing in vivo duration (R. 2. =0.44; p<0.05), and by one order of magnitude (94%) by 36.6 months. A stronger negative correlation (R. 2. =0.65) was observed between the total lifetime of the liner and free radical content. Discussion/Conclusion. The free-radical scavenging activity of the vitamin E appears to successfully prevent both in vivo and ex vivo oxidation for short durations. Without an increase in hydroperoxides, the oxidation cascade initiated by radiation-induced and lipid-derived free radicals appears to have been halted. Retrievals also gave no indication of wear in this timeframe, similar to improved wear resistance seen in first generation materials. Continued monitoring will be necessary at longer implant durations


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 46 - 46
1 Feb 2020
Currier J Currier B Jevsevar K Van Citters D
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Introduction. In an effort to provide a TKA bearing material that balances resistance to wear, mechanical failure and oxidation, manufacturers introduced antioxidant polyethylene. In many designs, this is accomplished through pre-blending the polymer with the antioxidant before consolidation and radiation crosslinking. This study reports the wear performance (in terms of thickness change) of a hindered phenol (PBHP) UHMWPE from analysis of an early series of knee retrievals and explores these questions: 1) What is early-time performance of this new bearing material? 2) Is there a difference in performance between fixed and mobile bearings in this design? 3) How does quantitative surface analysis help understand performance at the insert-tray modular interface?. Methods. A series of 100 consecutive Attune™ knee inserts (DePuy Synthes, Warsaw, IN) received at revision by an IRB approved retrieval laboratory between September 2014 and March 2019 were investigated. In vivo duration was 0–52 months. Both the fixed bearing design (n=74) and the rotating platform mobile bearing design (n=26) were included. Dimensional change was determined by measurement of each insert and compared to the as-manufactured dimensions, provided by the manufacturer. The insert-tray interfaces under the loaded bearing zones were analyzed with light interferometry using an optical surface profiler (NewView™ 7300, Zygo, Middlefield, CT). Statistical analyses to explore relationships between measured variables were conducted using SPSS. Results. Mean total through-thickness change of the inserts was 0.052 mm. Mean rate of thickness change for all inserts having in vivo duration > 12 months was 0.038 mm/year (fixed bearing 0.042, mobile bearing 0.029 mm/year). The rate of thickness change for all inserts showed a decreasing trend with duration that was not statistically significant, (rho -.244, p=.094); however, the mobile bearing cohort alone showed a significant decrease in thickness change rate with duration (rho= −.659; p=.014). Surface roughness (Sa) of the distal surface of the UHMWPE inserts under the bearing areas averaged 1.24 µm (range 0.12 – 8.53) and peak-to-valley height (PV) averaged 27.1 µm (range 4 – 95). Sa and PV both showed a decreasing trend with duration in vivo in the mobile bearing inserts, but that trend did not reach statistical significance (p= 0.05 criterion). Neither Sa nor PV showed correlation with measured thickness change. Discussion. This study indicates that the rate of thickness change of a relatively new antioxidant cross-linked bearing material is very similar to other reported wear rates of crosslinked knee inserts. Lower wear rate of mobile bearing inserts compared to fixed bearings also is consistent with earlier published studies. Direct comparison between quantitative thickness change and objective, quantitative surface metrology on the same series brings new information to the arena of measuring and reporting “wear” of UHMWPE and underscores the importance of the distinction between visual damage and actual thinning of the bearing. The systematic surface analysis of the modular interfaces showing that surface roughness (Sa) and total damage feature topography (PV) trend downward with in vivo duration of mobile bearings supports the hypothesis that relative motion at that interface may ‘polish out’ the surface topography over time. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 380 - 380
1 Dec 2013
Kretzer JP Pohl V Zeifang F Buelhoff M Sonntag R Reinders J
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Hemi shoulder arthroplasty is an attractive treatment for shoulder arthritis in particular if the natural glenoid is still intact. However, comparing the clinical results of hemi and total shoulder arthroplasty clearly shows lower survival for the hemi arthroplasty. One of the most common reasons for revision surgery is gleniod erosion, where the cartilage or bone is worn of. Aim of the current study was to analyse if the metallic articular surface of retrieved hemi shoulder arthroplasty is different from new implants. We hypothesized that the surface roughness will increased due the articulation and that metallic wear is detectable on the implants. Twelve retrieved and three brand new hemi shoulder arthroplasty were included. The surface roughness (Ra, Rz, Rmax, Rsk) was measured on different sites of the surface (center of the head and at the edge). The implants were further measured using a coordinate measuring machine to gain information on volumetric wear and geometrical alterations. Compared to new implants the surface roughness on the retrievals was significantly increased (Tab. 1), except for skewness. Although the roughness parameters within the retrieval group were generally higher at the center of the head compared to the edge, this difference was not significant. Apart from form deviations no volumetric wear was detectable on the heads (Fig. 1). The current results indicate that the metallic articular implant surface changes in vivo and that the material is hurt due to the articulation against the softer cartilage or bone. Although it can't be finally clarified by that study, to what extend the higher roughness is taking part in the process of the clinically observed erosion of the gleniod, it can be assumed that an increased roughness is disadvantageous. Possibly, the observed surface alterations won't occur clinically with harder materiel (e.g. ceramic), but this even needs to be validated


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_I | Pages 14 - 15
1 Jan 2003
Chapman-Sheath P Butler A Svhela M Gillies M Bruce W Walsh W
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Clinical implantation represents the ultimate experiment of any component and often demonstrates areas of strengths and weaknesses not predicted from in vitro testing. Mobile bearing knees incorporate an additional articulating interface between the flat distal PE insert and a highly polished metal tibial tray. This can allow the proximal interface to retain high conformity whilst leading to reduced stresses at the bone – prosthesis interface by permitting complex distal interface compensatory motion to occur (rotation and/or translation). Retrieval reports on many of the new generation of mobile bearing implants remains scarce. This study presented a retrieval analysis of 9 mobile bearing inserts that had be in situ for less than 24 months. Nine cemented mobile bearing implants (6 AP Glide, 1 LCS, 1 MBK and 1TRAK) were received into our Implant Retrieval Program. The femoral component, tibial tray and PE insert were macroscopically examined under a stereo-zoom microscope for evidence of damage. The PE inserts were graded for wear based on optical and SEM assessments. The proximal and distal surfaces of the PE inserts were subsequently assessed for surface roughness following ISO 97 (Ra and Rp) using a Surfanalyzer 5400 (Federal Products, Providence, RI). Virgin, unused PE inserts were analysed and served as a comparison to the retrieved implants. Time in situ time for these implants ranged from 6 months to 24 months (mean 18.6). The implants were revised for instability and pain (AP glide) or dislocation (TRAK). Damage to the femoral components, in general, was minimal with some evidence of a transfer film of PE. The proximal surface of the tibial trays presented evidence of PE transfer as well as some scratches but in general were intact. The proximal PE and distal PE articulating surfaces demonstrated significant areas of damage due to third body wear which was identified on EDAX to be PMMA. Areas of burnishing were also present at the proximal and distal interface. The damage, in part, correlated with the complex kinematics of each design


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. 92-B, Issue SUPP_I | Pages 154 - 154
1 Mar 2010
Clarke I Kubo K Lazennec Y Cattonne Y Anderson I Smith E Turnbull A Donaldson T
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From 1985 metal-on-metal (MOM) designs of resurfacing (RSA) and total hip arthroplasties (THR) have been available over a large diameter range (28–60mm). In-vitro studies indicated satisfactory low wear performance for all designs and diameters tested (wear = 0.1 to 7 mm3). While reports from many centers have been encouraging, some have reported adverse effects. We reviewed clinical and metal ion studies in large diameter retrievals and compared these to 28mm MOM cases. Patients with the latter THR ranged 36–76 years of age and were followed 9–11 years. Main finding in our revisions was osteolysis and pain. The 28mm ball was represented 86% of cases; 71% balls had stripe wear. For liners, 25% had circumferential stripe wear and impingement was evident in 64% cases. Seven cemented stems were recovered with impingement marks; 26 stems were undamaged and therefore not revised. Using the concept of ‘damage modes’ from McKellop, normal wear mode #1 was evident in only 14% of 28mm retrievals whereas incidence of ‘abnormal’ modes #2-4 approached 30% each. Thus the 28mm MOM appeared susceptible to impingement risks with CoCr liners. Summarizing MOM retrievals, damage modes 2–4 were most likely implicated in revisions. The performance of such ‘small diameter’ THRs will be contrasted to our large diameter THR and RSA experience. The questions to be reviewed include, how much of the reported MOM adversity was predictable and how much risk was due to. wear of small diameter MOM,. adverse cup positioning and hip instability,. cup-stem impingement issues or. design conformity issues?


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 129 - 129
1 May 2016
Kurtz S Arnholt C MacDonald D Higgs G Underwood R Chen A Klein G Hamlin B Lee G Mont M Cates H Malkani A Kraay M Rimnac C
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Introduction. Previous studies of retrieved CoCr alloy femoral heads have identified imprinting of the stem taper surface features onto the interior head bore, leading researchers to hypothesize that stem taper microgrooves may influence taper corrosion. However, little is known about the role of stem taper surface morphology on the magnitude of in vivo corrosion damage. We designed a matched cohort retrieval study to examine this issue. Methods. From a multi-institutional retrieval collection of over 3,000 THAs, 120 femoral head-stem pairs were analyzed for evidence of fretting and corrosion using a visual scoring technique based on the severity and extent of fretting and corrosion damage observed at the taper. A matched cohort design was used in which 60 CoCr head-stem pairs with a smooth stem taper were matched with 60 CoCr head-stem pairs having a micro-grooved surface, based on implantation time, flexural rigidity, apparent length of taper engagement, and head size. This study was adequately powered to detect a difference of 0.5 in corrosion scores between the two cohorts, with a power of 82% and 95% confidence. Both cohorts included CoCr and Ti-6-4 alloy femoral stems. A high precision roundness machine (Talyrond 585, Taylor Hobson, UK) was used to measure surface morphology and categorize the stem tapers into smooth vs. micro-grooved categories. Fretting and corrosion damage at the head/neck junction was characterized using a modified semi-quantitative adapted from the Goldberg method by three independent observers. This method separated corrosion damage into four visually determined categories: minimal, mild, moderate and severe damage. Results. Mild to severe damage (Fretting Corrosion Score ≥ 2) was observed in 75% of the 120 CoCr femoral heads (78% of the heads mated with micro-grooved stems (47/60), Fig. 1A) and 72% of the heads mated with smooth stems (43/60, Fig 1B). Fretting and corrosion damage was not significantly different between the two cohorts when evaluated at the CoCr femoral head bore (p =0.105, Mann Whitney test, Fig. 2A) or the male stem tapers (p =0.428, Fig. 2B). No implant or patient factors were associated with fretting corrosion; corrosion scores were not significantly associated with stem alloy in the two cohorts (p=0.669, Mann-Whitney test). Discussion. The results of this matched cohort retrieval study do not support the hypothesis that taper surfaces with micro-grooved stems exhibit increased in vivo fretting corrosion. We accounted for implant, patient, and clinical factors that may influence in vivo taper corrosion with the matched cohort design and by post hoc statistical analyses. However, this study is limited by the semi-quantitative method used for evaluating damage in these components. Therefore, additional research will be necessary to quantify the volume of metal release from these two cohorts. To view tables/figures, please contact authors directly


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 18 - 18
1 Mar 2013
Bolland B Maul C Cook R Roques A Tuke M Wood R Latham J
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The poor outcome of large head metal on metal total hip replacements (LHMOMTHR) in the absence of abnormal wear at the articulating surfaces has focussed attention on the trunnion / taper interface. The RedLux ultra-precision 3D form profiler provides a novel indirect optical method to detect small changes in the form and surface finish of the head taper as well as a quantitative assessment of wear volume. This study aimed to assess and compare qualitatively the tapers from well functioning small diameter, with poorly functioning LHMOMTHR's using the above technique. Method. 3 groups of retrieval tapers were analysed (Group 1: 28 mm CoCr heads from well functioning MOMTHRs (n=5); Group 2: Large diameter CoCr heads from LHMOMTHRs revised for failure secondary to adverse reaction to metal debris (n=5); Gp 3 (control): 28 mm heads from well functioning metal on Polyethylene (MOP) THRs; n=3). Clinical data on the retrievals was collated. The Redlux profiling of modular head tapers involves a non direct method whereby an imprint of the inside surface of a modular head is taken, and this is subsequently scanned by an optical non contact sensor using dedicated equipment [1]. The wear was also measured on the bearing surface [1]. RedLux profiling of the tapers produced a taper angle and 3D surface maps. The taper angles obtained with the Redlux method were compared to those obtained using CMM measurement on 3 parts. The Redlux profiling, including imprints, was also repeated 3 times to gauge potential errors. Results. There was no difference in mean 12/14 taper angles between groups. There was no difference in volumetric and linear wear at the bearing surface between groups. Only the LHMOMs showed transfer of pattern from the stem to the internal head taper, with clear demarcation of the contact and damaged area between head taper and stem trunnion (see figure 1 – interpretation of head taper surface features demonstrated using Redlux optical imaging). 3D surface mapping demonstrated wear patterns compatible with motion or deformations between taper and trunnion in the LHMOM group. These appearances were not seen in tapers from small diameter MOM and MOP THRs (see Figure 2). Discussion. Differences in appearance of the taper surface between poorly functioning LHMOMTHRs and well functioning MOP or MOM small diameter devices highlight an area of concern and potential contributor to the mode of early failure. Further work is required to fully qualify the Redlux method capabilities, and to understand the origin of the damage seen on those tapers, and the possible partial contribution of damage caused during retrieval


The Bone & Joint Journal
Vol. 97-B, Issue 1 | Pages 10 - 18
1 Jan 2015
Sabah SA Henckel J Cook E Whittaker R Hothi H Pappas Y Blunn G Skinner JA Hart AJ

Arthroplasty registries are important for the surveillance of joint replacements and the evaluation of outcome. Independent validation of registry data ensures high quality. The ability for orthopaedic implant retrieval centres to validate registry data is not known. We analysed data from the National Joint Registry for England, Wales and Northern Ireland (NJR) for primary metal-on-metal hip arthroplasties performed between 2003 and 2013. Records were linked to the London Implant Retrieval Centre (RC) for validation. A total of 67 045 procedures on the NJR and 782 revised pairs of components from the RC were included. We were able to link 476 procedures (60.9%) recorded with the RC to the NJR successfully. However, 306 procedures (39.1%) could not be linked. The outcome recorded by the NJR (as either revised, unrevised or death) for a primary procedure was incorrect in 79 linked cases (16.6%). The rate of registry-retrieval linkage and correct assignment of outcome code improved over time. The rates of error for component reference numbers on the NJR were as follows: femoral head category number 14/229 (5.0%); femoral head batch number 13/232 (5.3%); acetabular component category number 2/293 (0.7%) and acetabular component batch number 24/347 (6.5%). . Registry-retrieval linkage provided a novel means for the validation of data, particularly for component fields. This study suggests that NJR reports may underestimate rates of revision for many types of metal-on-metal hip replacement. This is topical given the increasing scope for NJR data. We recommend a system for continuous independent evaluation of the quality and validity of NJR data. Cite this article: Bone Joint J 2015;97-B:10–18


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 54 - 54
1 Mar 2017
Nguyen T Amundsen S Choi D Koch C Wright T Padgett D
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Introduction. Contemporary total knee systems accommodate for differential sizing between femoral and tibial components to allow surgeons to control soft tissue balancing and optimize rotation. One method some manufacturers use to allow differential sizing involves maintaining coronal articular congruency with a single radius of curvature throughout sizes while clipping the medial-lateral width, called a single coronal geometry system. Registry data show a 20% higher revision rate when the tibial component is smaller than the femur (downsizing) in the DePuy PFC system, a single coronal system, possibly from increased stresses from edge loading or varying articular congruency. We examined a different single coronal geometry knee system, Smith & Nephew Genesis II, to determine if edge loading is present in downsized tibial components by measuring area and location of deviation of the polyethylene articular surface damage. Methods. 45 Genesis II posterior-stabilized polyethylene inserts (12 matched and 33 downsized tibial components) were CT scanned. 3D reconstructions were registered to corresponding pristine component reconstructions, and 3D deviation maps of the retrieved articular surfaces relative to the pristine surfaces were created. Each map was exported as a point cloud to a custom MATLAB code to calculate the area and weighted center of deviation of the articular surfaces. An iterative k-means clustering algorithm was used to isolate regions of deviation, and a shrink-wrap algorithm was applied to calculate their areas. The area of deviation was calculated as the sum of all regions of deviation and was normalized to the area of the articular surface. The location of deviation was described using the weighted center of deviation and the location of maximum deviation on the articular surfaces relative to the center of the post (Fig. 1). Pearson product moment correlations were conducted to examine the correlation between length of implantation (LOI) and the medial and lateral areas of deviation for all specimens, matched components, and downsized components. Results. The mean LOIs for downsized and matched tibial components were not different (36±28 months vs 46±26 months, p=0.24). Areas of deviation for the medial and lateral sides for both downsized and matched components increased with LOI (p<0.001). Medial and lateral sides of matched retrievals were not different in location of maximum deviation, maximum deviation, and weighted center of deviation (p>0.4). The matched and downsized retrievals did not have different centers of deviation in the medial-lateral direction, maximum deviations, or locations of maximum deviations (p>0.1). Discussion. Our results suggest that downsizing the tibial component in the Genesis II system, a single coronal geometry system, did not affect the area or location of deviation on the articular surface. Overall, the weighted center of deviation remained close to the dwell point and did not change as a function of tibial downsizing. However, we saw deviation patterns biased peripherally for inserts with low LOI in both matched and downsized cohorts. With increasing LOI, the deviation expanded to cover the majority of the available articular surface. Our results suggest the need to further examine this and other systems determine the effects of differential sizing. For figures/tables, please contact authors directly.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 45 - 45
1 Apr 2019
Joyce T Giddins G
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Objective. We explanted NeuFlex metacarpophalangeal (MP) joint prostheses to identify common features, such as position of fracture, and thus better understand the reasons for implant failure. Methods. Explanted NeuFlex MP joint prostheses were retrieved as part of an-ongoing implant retrieval programme. Following revision MP joint surgery the implants were cleaned and sent for assessment. Ethical advice was sought but not required. The explants were photographed. The position of fracture, if any, was noted. Patient demographics were recorded. Results. Thirty NeuFlex MP explants were available. Seven (23%) were not fractured. Eleven explants (37%) had fractured at the hinge; nine (30%) had fractured at the junction of the distal stem and hinge; and three (10%) had fractured at both the hinge and distal stem. NeuFlex MP joint explants ranged in size from 0 to 40. Smaller sizes were retrieved from smaller fingers; larger implants came from the middle and index fingers. The age at revision ranged from 43 to 81 (median 58) years. Time in vivo ranged from 6 to 120 (median 58.5) months. All but two implants were obtained from rheumatoid joints, the remainder had osteoarthritis. Discolouration of some explants had occurred; other explants appeared to show no colour change. Conclusions. This is the first report of the position of fracture of NeuFlex explants. It is also the largest report of silicone arthroplasty explants. The majority (77%) had fractured. Nine (30%) NeuFlex explants had fractured at the junction of the distal stem and hinge; the typical position seen with Swanson and Sutter/Avanta MP joint explants. Eleven (37%) fractured across the hinge; this has not previously been reported although has been seen in in vitro testing. The hinge is thinner than the hinge-stem junction so may be at risk of more rapid failure, however the median time in vivo for hinge fractures was 63 months as opposed to 54 months for fractures at the distal stem. Intriguingly, 3 (10%) NeuFlex explants suffered fractures both at the hinge and at the junction of the distal stem and hinge which has also never been reported previously. Fracture at the junction of the distal stem and hinge shows the importance of subluxing forces in rheumatoid MP joints and therefore suggests these need to be mitigated as much as possible. Fracture across the hinge could indicate this as a position which could be increased in thickness, to increase the time taken to fracture, although there may be a concomitant increase in stiffness of the implant. With improved designs, patients might suffer fewer or later failures. The latest Norwegian Arthroplasty Registry report shows that revision MP joint arthroplasties accounted for 42% of all MP joint replacement operations in 2015. Therefore, this is an important area where opportunities exist to reduce revision rates


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_13 | Pages 1 - 1
1 Jun 2017
Panagiotopoulou V Davda K Hothi H Henckel J Cerquiglini A Goodier W Skinner J Hart A Calder P
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Introduction. The Precice nail is the latest intramedullary lengthening nail with excellent early outcomes. Implant complications have led to modification of the nail design. The aim of this study was to perform a retrieval study of Precice nails following lower limb lengthening. To assess macroscopic and microscopic changes to the implants and assess differences following design modification, with identification of potential surgical, implant and patient risk factors. Method. 15 nails were retrieved from 13 patients following lower limb lengthening. Macroscopic and microscopic surface damage to the nails were identified. Further analysis included radiology and micro-CT prior to sectioning. The internal mechanism was then analysed with Scanning Electron Microscopy and Energy Dispersive X-ray Spectroscopy to identify corrosion. Results. 7 male and 3 females underwent 12 femoral lengthenings, 9 antegrade and 3 retrograde. 3 females underwent tibial lengthening. All patients obtained the desired length with no implant failure and full regenerate consolidation. Surface degradation was noted on the telescopic part of every nail design, less on the latest implants. Microscopic analysis confirmed fretting and pitting corrosion. Following sectioning black debris was noted in all implants. The early designs were found to have fractured actuator pins and the pin and bearings had evidence of corrosive debris. The latest designs had evidence of biological deposits suggestive of fluid ingress within the nail. Conclusion. This study suggests fluid ingress occurs with every generation of Precice nail despite modifications. The presence of biological fluid could be an early warning sign of potential corrosion. This in theory could lead to actuator pin fracture and implant failure. The clinical relevance is the potential re-use of a “dormant” nail in patients requiring secondary limb segment lengthening. Retraction of the nail in-situ and re-use for further lengthening requires careful consent for potential implant failure


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 146 - 146
1 Mar 2010
Kubo K Clarke I Lazennec J Catonne Y Smith E Halim C Yamamoto K Donaldson T
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While there are many variation laboratory and clinical studies using metal-on-metal (MOM) bearings after introduction of the 28mm MOM THR in 1988, the mapping of wear phenomena in such retrieval cases has been mimimal. In laboratory study, 28mm MOM bearing’s wear-rate was low with “run-in” and “steady-state” than large diameter MOM without theory of fluid-filum lubrication. In clinical results were not superior to the same way of laboratory study. We present a detailed analysis of 33 retrieved MOM hip bearings with 1–11 years follow-up,. We compiled 33 retrieval cases (MetasulTM: Zimmer/CenterPulse Inc., Austin, TX) including clinical information, ion concentrations from ball diameters, cup designs and stripe wear damage. The bearing surfaces were mapped using reflected light microscope (RLM), white light interferometer (Zygo Newview 600, Zygo.) and SEM(XL-30 FEG). Wear maps were constructed according to types of surface wear identified. Patients ranged from 36 to 76 years of age (Means: 56.9 years); 54% were males. Main causes for revision were progressive radiographic lines around the cups, osteolysis and pain. The 28mm ball diameter was used in 86% of cases (largest = 52mm ball). The CoCr liner incorporated a polyethylene adaptor in 75% of cases. Cup diameter > 50mm was present in 75% of cases. Eight femoral stems were recovered and all showed major impingement marks around the neck and five also had a metallosis (Mode-4A). Stripe wear was evident on 71% of CoCr balls with medial stripes twice as common as lateral. Stripe wear was identified in 25% of CoCr liners and extended 25–160° circumference around the liners. Clear liner rim damage was present in 10 (30%) and 3 demostrated severe damage of polyethelene adaptors. There are many limitations to such retrieval studies. These data are biased to cases that failed due to hip pain, radiographic signs of progressive osteolysis and some with high levels of metal ions. There was also the bias of having predominantly a CoCr sandwich design (polyethylene adaptor in 75% of cases). In early 1980s, the thin walled UHMWPE cup was introduced and used larger diameter balls for decreased risk of dislocation. However, unfortunally these big-ball cups produced significant PE wear debris, and diameter trends were returned to the Chanley’s small-ball paradigm again. In the same time (late of 1980’s), these second-generation MOM (28,32mm) was introduced for low wear characteristics alternate THR bearings, with sacrificing of joint stability and motion range. However, use of the small ball added well-known risks of impingement, subluxation and dislocation with rigid cups. In this study, using the ‘damage modes’ from McKellop, normal mode-1 wear occurred in only 14% of cases whereas modes 2–4 had an incidence approaching 30% each and signs of cup impingement were evident in 64% of cases. Thus summarizing MOM wear phenomena in “small” 28mm sandwich cup designs, there was retrieval evidence showing that damage modes 2–4 likely placed these patients at risk for adverse wear effects


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 139 - 139
1 Jan 2013
Bolland B Maul C Cook R Roques A Wood R Latham J
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The poor outcome of large head metal on metal total hip replacements (LHMOMTHR) in the absence of abnormal wear at the articulating surfaces has focussed attention on the trunnion/taper interface. The RedLux ultra-precision 3D form profiler provides a novel indirect optical method to detect small changes in form and surface finish of the head taper as well as a quantitative assessment of wear volume. This study aimed to assess and compare qualitatively the tapers from small diameter with LHMOMTHR's. 3 groups of retrieval tapers were analysed (Group 1: 28mm CoCr heads from MOMTHRs (n=5); Group 2: Large diameter CoCr heads from LHMOMTHRs (n=5); Group 3: 28mm heads from metal on polyethylene (MOP) THRs; n=3). Clinical data on the retrievals was collated. Both bearing surfaces and head tapers were measured for wear using the Redlux profiling non contact measurement system. Measurements included taper angle and 3D surface maps. Taper angles obtained with the Redlux method were compared to those obtained using CMM measurement on 3 parts. The Redlux profiling, including imprints, was also repeated 3 times to gauge potential errors. There was no difference in mean 12/14 taper angles between groups. There was no difference in volumetric and linear wear at the bearing surface between groups. Only the LHMOMs showed transfer of pattern from the stem to the internal head taper, with clear demarcation of the contact and damaged area between head taper and stem trunnion. 3D surface mapping demonstrated wear patterns compatible with motion or deformations between taper and trunnion in the LHMOM group alone. Discussion: Differences in appearance of the taper surface between LHMOMTHRs and MOP or MOM small diameter devices highlight an area of concern and potential contributor to the mode of early failure. Further work is required to fully qualify the Redlux method capabilities