Analysis of the Attune tibial tray backside: A comparative retrieval study.

OBJECTIVES: The Attune total knee arthroplasty (TKA) has been used in over 600 000 patients worldwide. Registry data show good clinical outcome; however, concerns over the cement-tibial interface have been reported. We used retrieval analysis to give further insight into this controversial topic. METHODS: We examined 12 titanium (Ti) PFC Sigma implants, eight cobalt-chromium (CoCr) PFC Sigma implants, eight cobalt-chromium PFC Sigma rotating platform (RP) implants, and 11 Attune implants. We used a peer-reviewed digital imaging method to quantify the amount of cement attached to the backside of each tibial tray. We then measured: 1) the size of tibial tray thickness, tray projections, peripheral lips, and undercuts; and 2) surface roughness (Ra) on the backside and keel of the trays. Statistical analyses were performed to investigate differences between the two designs. RESULTS: There was no evidence of cement attachment on any of the 11 Attune trays examined. There were significant differences between Ti and CoCr PFC Sigma implants and Attune designs (p < 0.05); however, there was no significant difference between CoCr PFC Sigma RP and Attune designs (p > 0.05). There were significant differences in the design features between the investigated designs (p < 0.05). CONCLUSION: The majority of the earliest PFC Sigma designs showed evidence of cement, while all of the retrieved Attune trays and the majority of the RP PFC trays in this study had no cement attached. This may be attributable to the design differences of these implants, in particular in relation to the cement pockets. Our results may help explain a controversial aspect related to cement attachment in a recently introduced TKA design.Cite this article: A. Cerquiglini, J. Henckel, H. Hothi, P. Allen, J. Lewis, A. Eskelinen, J. Skinner, M. T. Hirschmann, A. J. Hart. Analysis of the Attune tibial tray backside: A comparative retrieval study. Bone Joint Res 2019;8:136-145. DOI: 10.1302/2046-3758.83.BJJ-2018-0102.R2.

Wear performance of retrieved metal-on-metal Pinnacle hip arthroplasties implanted before and after 2007.

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.

A retrieval analysis of the Precice intramedullary limb lengthening system.

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.

The risk of cardiac failure following metal-on-metal hip arthroplasty.

AIMS: The aim of this study was to determine whether patients with metal-on-metal (MoM) arthroplasties of the hip have an increased risk of cardiac failure compared with those with alternative types of arthroplasties (non-MoM). PATIENTS AND METHODS: A linkage study between the National Joint Registry, Hospital Episodes Statistics and records of the Office for National Statistics on deaths was undertaken. Patients who underwent elective total hip arthroplasty between January 2003 and December 2014 with no past history of cardiac failure were included and stratified as having either a MoM (n = 53 529) or a non-MoM (n = 482 247) arthroplasty. The primary outcome measure was the time to an admission to hospital for cardiac failure or death. Analysis was carried out using data from all patients and from those matched by propensity score. RESULTS: The risk of cardiac failure was lower in the MoM cohort compared with the non-MoM cohort (adjusted hazard ratio (aHR) 0.901; 95% confidence interval (CI) 0.853 to 0.953). The risk of cardiac failure was similar following matching (aHR 0.909; 95% CI 0.838 to 0.987) and the findings were consistent in subgroup analysis. CONCLUSION: The risk of cardiac failure following total hip arthroplasty was not increased in those in whom MoM implants were used, compared with those in whom other types of prostheses were used, in the first seven years after surgery. Cite this article: Bone Joint J 2018;100-B:20-7.

Retrieval analysis of metal and ceramic femoral heads on a single CoCr stem design.

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 mm3/year (0.030 to 0.448) for the metal head group and 0.084 mm3/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.

Assessment of the equivalence of a generic to a branded femoral stem.

AIMS: The aim of this study was to compare the design of the generic OptiStem XTR femoral stem with the established Exeter femoral stem. MATERIALS AND METHODS: We obtained five boxed, as manufactured, implants of both designs at random (ten in total). Two examiners were blinded to the implant design and independently measured the mass, volume, trunnion surface topography, trunnion roughness, trunnion cone angle, Caput-Collum-Diaphyseal (CCD) angle, femoral offset, stem length, neck length, and the width and roughness of the polished stem shaft using peer-reviewed methods. We then compared the stems using these parameters. RESULTS: We found that the OptiStems were lighter (p < 0.001), had a rougher trunnion surface (p < 0.001) with a greater spacing and depth of the machined threads (p < 0.001), had greater trunnion cone angles (p = 0.007), and a smaller radius at the top of the trunnion (p = 0.007). There was no difference in stem volume (p = 0.643), CCD angle (p = 0.788), offset (p = 0.993), neck length (p = 0.344), stem length (p = 0.808), shaft width (p = 0.058 to 0.720) or roughness of the polished surface (p = 0.536). CONCLUSION: This preliminary investigation found that whilst there were similarities between the two designs, the generic OptiStem is different to the branded Exeter design. Cite this article: Bone Joint J 2017;99-B:310-16.

Clinically insignificant trunnionosis in large-diameter metal-on-polyethylene total hip arthroplasty.

OBJECTIVES: Mechanical wear and corrosion at the head-stem junction of total hip arthroplasties (THAs) (trunnionosis) have been implicated in their early revision, most commonly in metal-on-metal (MOM) hips. We can isolate the role of the head-stem junction as the predominant source of metal release by investigating non-MOM hips; this can help to identify clinically significant volumes of material loss and corrosion from these surfaces. METHODS: In this study we examined a series of 94 retrieved metal-on-polyethylene (MOP) hips for evidence of corrosion and material loss at the taper junction using a well published visual grading method and an established roundness-measuring machine protocol. Hips were retrieved from 74 male and 20 female patients with a median age of 57 years (30 to 76) and a median time to revision of 215 months (2 to 324). The reasons for revision were loosening of both the acetabular component and the stem (n = 29), loosening of the acetabular component (n = 58) and infection (n = 7). No adverse tissue reactions were reported by the revision surgeons. RESULTS: Evidence of corrosion was observed in 55% of hips. The median Goldberg taper corrosion score was 2 (1 to 4) and the annual rate of material loss at the taper was 0.084 mm3/year (0 to 0.239). The median trunnion corrosion score was 1 (1 to 3). CONCLUSIONS: We have reported a level of trunnionosis for MOP hips with large-diameter heads that were revised for reasons other than trunnionosis, and therefore may be clinically insignificant.Cite this article: H. S. Hothi, D. Kendoff, C. Lausmann, J. Henckel, T. Gehrke, J. Skinner, A. Hart. Clinically insignificant trunnionosis in large-diameter metal-on-polyethylene total hip arthroplasty. Bone Joint Res 2017;6:52-56. DOI: 10.1302/2046-3758.61.BJR-2016-0150.R2.

Are all metal-on-metal hip revision operations contributing to the National Joint Registry implant survival curves? : a study comparing the London Implant Retrieval Centre and National Joint Registry datasets.

AIMS: The National Joint Registry for England, Wales and Northern Ireland (NJR) has extended its scope to report on hospital, surgeon and implant performance. Data linkage of the NJR to the London Implant Retrieval Centre (LIRC) has previously evaluated data quality for hip primary procedures, but did not assess revision records. METHODS: We analysed metal-on-metal hip revision procedures performed between 2003 and 2013. A total of 69 929 revision procedures from the NJR and 929 revised pairs of components from the LIRC were included. RESULTS: We were able to link 716 (77.1%) revision procedures on the NJR to the LIRC. This meant that 213 (22.9%) revision procedures at the LIRC could not be identified on the NJR. We found that 349 (37.6%) explants at the LIRC completed the full linkage process to both NJR primary and revision databases. Data completion was excellent (> 99.9%) for revision procedures reported to the NJR. DISCUSSION: This study has shown that only approximately one third of retrieved components at the LIRC, contributed to survival curves on the NJR. We recommend prospective registry-retrieval linkage as a tool to feedback missing and erroneous data to the NJR and improve data quality. TAKE HOME MESSAGE: Prospective Registry - retrieval linkage is a simple tool to evaluate and improve data quality on the NJR.

Validation of primary metal-on-metal hip arthroplasties on the National Joint Registry for England, Wales and Northern Ireland using data from the London Implant Retrieval Centre: a study using the NJR dataset.

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.

Segond fracture in an adult is not pathognomonic for ACL injury.

The Segond fracture is an avulsion fracture of the lateral tibial plateau and is considered pathognomonic for anterior cruciate ligament (ACL) injury. A case of a Segond fracture occurring with a clinically, radiologically and arthroscopically intact ACL is presented. This was associated with a serious injury to the posterolateral corner requiring surgical reconstruction. Relevant literature is discussed, and the suggestion is made that, whilst an ACL rupture may be the most commonly noted soft tissue component associated with a Segond fracture, the clinician should have a high level of suspicion for other serious soft tissue injuries. Level of evidence V.

A review of rapid prototyped surgical guides for patient-specific total knee replacement.

Improvements in the surgical technique of total knee replacement (TKR) are continually being sought. There has recently been interest in three-dimensional (3D) pre-operative planning using magnetic resonance imaging (MRI) and CT. The 3D images are increasingly used for the production of patient-specific models, surgical guides and custom-made implants for TKR. The users of patient-specific instrumentation (PSI) claim that they allow the optimum balance of technology and conventional surgery by reducing the complexity of conventional alignment and sizing tools. In this way the advantages of accuracy and precision claimed by computer navigation techniques are achieved without the disadvantages of additional intra-operative inventory, new skills or surgical time. This review describes the terminology used in this area and debates the advantages and disadvantages of PSI.

The relationship between the angle of version and rate of wear of retrieved metal-on-metal resurfacings: a prospective, CT-based study.

We measured the orientation of the acetabular and femoral components in 45 patients (33 men, 12 women) with a mean age of 53.4 years (30 to 74) who had undergone revision of metal-on-metal hip resurfacings. Three-dimensional CT was used to measure the inclination and version of the acetabular component, femoral version and the horizontal femoral offset, and the linear wear of the removed acetabular components was measured using a roundness machine. We found that acetabular version and combined version of the acetabular and femoral components were weakly positively correlated with the rate of wear. The acetabular inclination angle was strongly positively correlated with the rate of wear. Femoral version was weakly negatively correlated with the rate of wear. Application of a threshold of > 5 µm/year for the rate of wear in order to separate the revisions into low or high wearing groups showed that more high wearing components were implanted outside Lewinnek's safe zone, but that this was mainly due to the inclination of the acetabular component, which was the only parameter that significantly differed between the groups. We were unable to show that excess version of the acetabular component alone or combined with femoral version was associated with an increase in the rate of wear based on our assessment of version using CT.

Quantification of the difference between 3D CT and plain radiograph for measurement of the position of medial unicompartmental knee replacements.

The aim of this study was to quantify the differences in measurements obtained from 3D Computed Tomography and plain radiograph, for the positioning of the tibial component of the Oxford unicompartmental knee replacement. Post-operative 3D Computed Tomography data and plain radiographs (long antero-posterior (AP) and short lateral) were obtained for 28 knees of patients who had undergone medial unicompartmental knee replacement. Parameters of the orientation/positioning of the tibial component: Varus/valgus, posterior tibial slope and rotation were measured with both modalities. Bland-Altman plots were used to calculate the 1.96 standard deviation limits of agreement (LOA) between imaging modalities. Intra class correlation was used to assess inter-method and inter-rater reliability (>0.81 = very good reliability). Radiographs were less reliable in all parameters, when compared with 3D CT (intra class correlation coefficients: tibial rotation 0.94 vs 0.96, varus/valgus 0.76 vs 0.94, and posterior tibial slope 0.82 vs 0.92). The LOA were -4.9° to 3.4° for varus/valgus (bias -0.7°, one third >3° different); -4.9° to 0.1° for posterior tibial slope (bias -2.4°, one third >3° different); and -20.6° to 16.1° for rotation (bias -2.2°, one third >10° different). There was some disagreement between measurement by 3D Computed Tomography and plain radiograph for all three parameters of tibial component orientation, especially tibial rotation. This will be particularly relevant to research into the relationship between the accuracy of implant positioning/orientation and patient satisfaction/implant survival rates. This method offers a more reliable standard for the reporting of knee arthroplasty.

The painful metal-on-metal hip resurfacing.

We carried out metal artefact-reduction MRI, three-dimensional CT measurement of the position of the component and inductively-coupled plasma mass spectrometry analysis of cobalt and chromium levels in whole blood on 26 patients with unexplained pain following metal-on-metal resurfacing arthroplasty. MRI showed periprosthetic lesions around 16 hips, with 14 collections of fluid and two soft-tissue masses. The lesions were seen in both men and women and in symptomatic and asymptomatic hips. Using three-dimensional CT, the median inclination of the acetabular component was found to be 55 degrees and its positioning was outside the Lewinnek safe zone in 13 of 16 cases. Using inductively-coupled plasma mass spectrometry, the levels of blood metal ions tended to be higher in painful compared with well-functioning metal-on-metal hips. These three clinically useful investigations can help to determine the cause of failure of the implant, predict the need for future revision and aid the choice of revision prostheses.

Computer-assisted hip resurfacing surgery using the acrobot navigation system.

The authors have previously reported on the laboratory development of the Acrobot Navigation System for accurate computer-assisted hip resurfacing surgery. This paper describes the findings of using the system in the clinical setting and including the improvements that have been made to expedite the procedure. The aim of the present system is to allow accurate planning of the procedure and precise placement of the prosthesis in accordance with the plan, with a zero intraoperative time penalty in comparison to the standard non-navigated technique. At present the navigation system is undergoing final clinical evaluation prior to a clinical study designed to demonstrate the accuracy of outcome compared with the conventional technique. While full results are not yet available, this paper describes the techniques that will be used to evaluate accuracy by comparing pre-operative computed tomography (CT)-based plans with post-operative CT scans. Example qualitative clinical results are included based on visual comparison of the plan with post-operative X-rays.

Preoperative planning and intraoperative guidance for accurate computer-assisted minimally invasive hip resurfacing surgery.

Hip resurfacing is an alternative to total hip replacement (THR) and is particularly suitable for the younger, more active patient. However, it is a more demanding procedure. This paper describes a system that enables the surgeon to plan the surgery preoperatively with optimally sized and placed components, and then transfer this plan to an intraoperative system that registers computer models to the real patient and tracks surgical tools, allowing the surgeon to ensure that the bone is resected correctly and that the components are fitted in accordance with the plan. The paper describes a series of instruments used with the system which are locked to the bone. These instruments serve the dual purpose of soft tissue retraction and bone immobilization. The system will shortly be the subject of laboratory and clinical evaluation. Registration, a cornerstone of the tracked instrument system, has been tested, and accuracy measures are provided. Experimental results for the remainder of the system will be provided after clinical trials.

Very low-dose computed tomography for planning and outcome measurement in knee replacement. The imperial knee protocol.

Surgeons need to be able to measure angles and distances in three dimensions in the planning and assessment of knee replacement. Computed tomography (CT) offers the accuracy needed but involves greater radiation exposure to patients than traditional long-leg standing radiographs, which give very little information outside the plane of the image. There is considerable variation in CT radiation doses between research centres, scanning protocols and individual scanners, and ethics committees are rightly demanding more consistency in this area. By refining the CT scanning protocol we have reduced the effective radiation dose received by the patient down to the equivalent of one long-leg standing radiograph. Because of this, it will be more acceptable to obtain the three-dimensional data set produced by CT scanning. Surgeons will be able to document the impact of implant position on outcome with greater precision.

Hands-on robotic unicompartmental knee replacement: a prospective, randomised controlled study of the acrobot system.

We performed a prospective, randomised controlled trial of unicompartmental knee arthroplasty comparing the performance of the Acrobot system with conventional surgery. A total of 27 patients (28 knees) awaiting unicompartmental knee arthroplasty were randomly allocated to have the operation performed conventionally or with the assistance of the Acrobot. The primary outcome measurement was the angle of tibiofemoral alignment in the coronal plane, measured by CT. Other secondary parameters were evaluated and are reported. All of the Acrobot group had tibiofemoral alignment in the coronal plane within 2 degrees of the planned position, while only 40% of the conventional group achieved this level of accuracy. While the operations took longer, no adverse effects were noted, and there was a trend towards improvement in performance with increasing accuracy based on the Western Ontario and McMaster Universities Osteoarthritis Index and American Knee Society scores at six weeks and three months. The Acrobot device allows the surgeon to reproduce a pre-operative plan more reliably than is possible using conventional techniques which may have clinical advantages.

Robotic clinical trials of uni-condylar arthroplasty.

A randomised clinical trial has been completed for uni-condylar arthroplasty. The trial, under the auspices of the UK MHRA, comprised 15 knees of patients undergoing conventional surgery, and 13 knees of patients who had robotic surgery using the Acrobot hands-on robotic system. The results of the trial were checked by comparing post-op CT scans with pre-op CT-based plans, and show a significant improvement in accuracy using the robot. The technical concept of the Acrobot approach is also described. Details of the complete system are outlined, including the pre-operative planner. The plan incorporates 3D CT models of the leg, together with CAD models of prostheses that can be used to plan the leg alignment, position the prostheses, plan the shape of the cuts required and generate the regions within which cuts must be constrained. The robotic system is also described, together with the methods for locating, clamping, cutting and monitoring the patient. An outline is given of the means by which the preoperative model is registered or aligned to the intra-operative position of the patient and of the robot, without the need for fiducial markers. Results of the randomised clinical trial are also discussed.