Developmental dysplasia of the hip (DDH) can be managed through a variety of different surgical approaches from closed reduction to simple tenotomies of the adductors and through to osteotomies of the femur and pelvis. The rate of redislocation following open reduction for the treatment of DDH may be affected by the number of intraoperative surgeons. We performed a retrospective cohort analysis of 109 patients who underwent open reduction with or without bony osteotomies as a primary intervention between 2013 and 2023. We measured the number of redislocations and number of operating surgeons (either 1 or 2 operating surgeons) to assess for any correlation. 109 patients were identified and corresponded to 121 primary hip operations, the mean age at operation was 82.2 months (range 6 to 739 months). During the 10-year period 7 hip redislocations were identified.Introduction
Materials and methods
Patient education programmes prior to hip and knee arthroplasty reduce anxiety and create realistic expectations. While traditionally delivered in-person, the Covid-19 pandemic has necessitated change to remote delivery. We describe a ‘Virtual Joint School’ (VJS) model introduced at Ysbyty Gwynedd, and present patient feedback to it. Eligible patients first viewed online educational videos created by our Multi-Disciplinary Team (MDT); and then attended an interactive virtual session where knowledge was reinforced. Each session was attended by 8–10 patients along with a relative/friend; and was hosted by the MDT consisting of nurses, physiotherapists, occupational therapists, and a former patient who provided personal insight. Feedback on the VJS was obtained prospectively using an electronic questionnaire. From July 2022 to February 2023, 267 patients attended the VJS; of which 117 (44%) responded to the questionnaire. Among them, 87% found the pre-learning videos helpful and comprehensible, 92% felt their concerns were adequately addressed, 96% felt they had sufficient opportunity to ask questions and 96% were happy with the level of confidentiality involved. While 83% felt they received sufficient support from the health board to access the virtual session, 63% also took support from family/friends to attend it. Only 15% felt that they would have preferred a face-to-face format. Finally, by having ‘virtual’ sessions, each patient saved, on average, 38 miles and 62 minutes travel (10,070 miles and 274 hours saved for 267 patients). Based on the overwhelmingly positive feedback, we recommend implementation of such ‘Virtual Joint Schools’ at other arthroplasty centres as well.
Meniscal root tears can result from traumatic injury to the knee or gradual degeneration. When the root is injured, the meniscus becomes de-functioned, resulting in abnormal distribution of hoop stresses, extrusion of the meniscus, and altered knee kinematics. If left untreated, this can cause articular cartilage damage and rapid progression of osteoarthritis. Multiple repair strategies have been described; however, no best fixation practice has been established. To our knowledge, no study has compared suture button, interference screw, and HEALICOIL KNOTLESS fixation techniques for meniscal root repairs. The goal of this study is to understand the biomechanical properties of these fixation techniques and distinguish any advantages of certain techniques over others. Knowledge of fixation robustness will aid in surgical decision making, potentially reducing failure rates, and improving clinical outcomes. 19 fresh porcine tibias with intact medial menisci were randomly assigned to four groups: 1) native posterior medial meniscus root (PMMR) (n = 7), 2) suture button (n = 4), 3) interference screw (n = 4), or 4) HEALICOIL KNOTLESS (n = 4). In 12 specimens, the PMMR was severed and then refixed by the specified group technique. The remaining seven specimens were left intact. All specimens underwent cyclic loading followed by load-to-failure testing. Elongation rate; displacement after 100, 500, and 1000 cycles; stiffness; and maximum load were recorded. Repaired specimens had greater elongation rates and displacements after 100, 500, and 1000 cycles than native PMMR specimens (p 0.05). The native PMMR showed greater maximum load than all repair techniques (p 0.05). In interference screw and HEALICOIL KNOTLESS specimens, failure occurred as the suture was displaced from the fixation and tension was gradually lost. In suture button specimens, the suture was either displaced or completely separated from the button. In some cases, tear formation and partial failure also occurred at the meniscus luggage tag knot. Native PMMR specimens failed through meniscus or meniscus root tearing. All fixation techniques showed similar biomechanical properties and performed inferiorly to the native PMMR. Evidence against significant differences between fixation techniques suggests that the HEALICOIL KNOTLESS technique may present an additional option for fixation in meniscal root repairs. While preliminary in vitro evidence suggests similarities between fixation techniques, further research is required to determine if clinical outcomes differ.
Major orthopaedic fractures are an independent risk factor for the development of venous thromboembolism (VTE), which are significant causes of preventable morbidity and mortality in trauma patients. Despite thromboprophylaxis, patients who sustain a pelvic or acetabular fracture (PA) continue to have high rates of VTE (12% incidence). Thrombelastography (TEG) is a whole-blood, point-of-care test which provides an overview of the clotting process. Maximal amplitude (MA), from TEG analysis, is the measure of clot strength and values ≥65mm have been used to quantify hypercoagulability and increased VTE risk. Therefore, the primary aim was to use serial TEG analysis to quantify the duration of hypercoagulability, following surgically treated PA fractures. This is a single centre, prospective cohort study of adult patients 18 years or older with surgically treated PA fractures. Consecutive patients were enrolled from a Level I trauma centre and blood draws were taken over a 3-month follow-up period for serial TEG analysis. Hypercoagulability was defined as MA ≥65mm. Exclusion criteria: bleeding disorders, active malignancy, current therapeutic anticoagulation, burns (>20% of body surface) and currently, or expecting to become pregnant within study timeframe. Serial TEG analysis was performed using a TEG6s hemostasis analyzer (Haemonetics Corp.) upon admission, pre-operatively, on post-operative day (POD) 1, 3, 5, 7 (or until discharged from hospital, whichever comes sooner), then in follow-up at 2-, 4-, 6-weeks and 3-months post-operatively. Patients received standardized thromboprophylaxis with low molecular weight heparin for 28 days post-operatively. VTE was defined as symptomatic DVT or PE, or asymptomatic proximal DVT, and all participants underwent a screening post-operative lower extremity Doppler ultrasound on POD3. Descriptive statistics were used to determine the association between VTE events and MA values. For the primary outcome measure, the difference between the MA threshold value (≥65mm) and serial MA measures, were compared using one-sided t-tests (α=0.05). Twenty-eight patients (eight females, 29%) with a mean age of 48±18 years were included. Acetabular fractures were sustained by 13 patients (46%), pelvic fractures by 14 patients (50%), and one patient sustained both. On POD1, seven patients (25%) were hypercoagulable, with 21 patients (78%) being hypercoagulable by POD3, and 17 patients (85%) by POD5. The highest average MA values (71.7±3.9mm) occurred on POD7, where eight patients (89%) were hypercoagulable. At 2-weeks post-operatively, 16 patients (94%) were hypercoagulable, and at four weeks, when thromboprophylaxis was discontinued, six patients (40%) remained hypercoagulable. Hypercoagulability persisted for five patients (25%) at 6-weeks and for two patients (10%) by three months. There were six objectively diagnosed VTE events (21.4%), five were symptomatic, with a mean MA value of 69.3mm±4.3mm at the time of diagnosis. Of the VTE events, four occurred in participants with acetabular fractures (three male, 75%) and two in those with pelvic fractures (both males). At 4-weeks post-operatively, when thromboprophylaxis is discontinued, 40% of patients remained hypercoagulable and likely at increased risk for VTE. At 3-months post-operatively, 10% of the cohort continued to be hypercoagulable. Serial TEG analysis warrants further study to help predict VTE risk and to inform clinical recommendations following PA fractures.
The aim of this study was to surveil whether the standard operating procedure created for the NHS Golden Jubilee sufficiently managed COVID-19 risk to allow safe resumption of elective orthopaedic surgery. This was a prospective study of all elective orthopaedic patients within an elective unit running a green pathway at a COVID-19 light site. Rates of preoperative and 30-day postoperative COVID-19 symptoms or infection were examined for a period of 40 weeks. The unit resumed elective orthopaedic services on 29 June 2020 at a reduced capacity for a limited number of day-case procedures with strict patient selection criteria, increasing to full service on 29 August 2020 with no patient selection criteria.Aims
Methods
In the vast majority of patients, the anatomical and mechanical axes of the tibia in the coronal plane are widely accepted to be equivalent. This philosophy guides the design and placement of orthopaedic implants within the tibia and in both the knee and ankle joints. However, the presence of coronal tibial bowing may result in a difference between these two axes and hence cause suboptimal placement of implanted prostheses. Although the prevalence of tibial bowing in adults has been reported in Asian populations, to date no exploration of this phenomenon in a Western population has been conducted. The aim of this study was to quantify the prevalence of coronal tibial bowing in a Western population. This was an observational retrospective cohort study using anteroposterior long leg radiographs collected prior to total knee arthroplasty in our high volume arthroplasty unit. Radiographs were reviewed using a Picture Archiving and Communication System. Using a technique previously described in the literature for assessment of tibial bowing, two lines were drawn, each one third of the length of the tibia. The first line was drawn between the tibial spines and the centre of the proximal third of the tibial medullary canal. The second was drawn from the midpoint of the talar dome to the centre of the distal third of the tibial medullary canal. The angle subtended by these two lines was used to determine the presence of bowing. Bowing was deemed significant if more than two degrees. The position of the apex of the bow determined whether it was medial or lateral. Measurements were conducted by a single observer and 10% of measurements were repeated by the same observer and also by two separate observers to allow calculation of intraclass correlation coefficients (ICCs). A total of 975 radiographs consecutively performed in the calendar years 2015–16 were reviewed, 485 of the left leg and 490 of the right. In total 399 (40.9%) tibiae were deemed to have bowing more than two degrees. 232 (23.8%) tibiae were bowed medially and 167 (17.1%) were bowed laterally. The mean bowing angle was 3.51° (s.d. 1.24°) medially and 3.52° (s.d. 1.33°) laterally. Twenty-three patients in each group (9.9% medial/13.7% lateral) were bowed more than five degrees. The distribution of bowing angles followed a normal distribution, with the maximal angle observed 10.45° medially and 9.74° laterally. An intraobserver ICC of 0.97 and a mean interobserver ICC of 0.77 were calculated, indicating excellent reliability. This is the first study reporting the prevalence of tibial bowing in a Western population. In a significant proportion of our sample, there was divergence between the anatomical and mechanical axes of the tibia. This finding has implications for both the design and implantation of orthopaedic prostheses, particularly in total knee arthroplasty. Further research is necessary to investigate whether prosthetic implantation based on the mechanical axis in bowed tibias results in suboptimal implant placement and adverse clinical outcomes.
The meniscus is comprised largely of type I collagen, as well as fibrochondrocytes and proteoglycans. In articular cartilage and intervertebral disc, proteoglycans make a significant contribution to mechanical stiffness of the tissue via negatively charged moieties which generate Donnan osmotic pressures. To date, such a role for proteoglycans in meniscal tissue has not been established. This study aimed to investigate whether meniscal proteoglycans contribute to mechanical stiffness of the tissue via electrostatic effects. Following local University Ethics Committee approval, discs of meniscal tissue two millimetres thick and of five millimetres diameter were obtained from 12 paired fresh frozen human menisci, from donors < 6 5 years of age, with no history of osteoarthritis or meniscal injury. Samples were taken from anterior, middle and posterior meniscal regions. Each disc was placed within a custom confined compression chamber, permeable at the top and bottom only and then bathed in one of three solutions − 0.14M PBS (mimics cellular environment), deionised water (negates effect of mobile ions) or 3M PBS (negates all ionic effects). The apparatus was mounted within a Bose Electroforce 3100 materials testing machine and a 0.3N preload was applied. The sample was allowed to reach equilibrium, before being subjected to a 10% ramp compressive strain followed by a 7200 second hold phase. Equal numbers of samples from each meniscus and meniscal region were tested in each solution. Resultant stress relaxation curves were fitted to a nonlinear poroviscoelastic model with strain dependent permeability using FEBio finite element modelling software. Goodness of fit (R2) was assessed using a coefficient of determination. All samples were assayed for proteoglycan content. Comparison of resultant mechanical parameters was undertaken using multivariate ANOVA with Bonferroni adjustment for multiple comparisons. 36 samples were tested. A significant difference (p < 0 .05) was observed in the value of the Young's modulus (E) between samples tested in deionised water compared to 0.14M/3M PBS, with the meniscus found to be stiffest in deionised water (E = 1.15 MPa) and least stiff in 3M PBS (E = 0.43 MPa), with the value of E in 0.14M PBS falling in between (0.68 MPa). No differences were observed in the zero strain permeability or the exponential strain dependent/stiffening coefficients. The viscoelastic coefficient and relaxation time values were not found to improve model fit and were thus held at zero. The mean R2 value was 0.78, indicating a good fit and did not differ significantly between solutions. Proteoglycan content was not found to differ with solution, but was found to be significantly increased in the middle region of both menisci. Proteoglycans make a significant electrostatic contribution to mechanical stiffness of the meniscus, increasing it by 58% in the physiological condition, and are hence integral to its function. It is important to include the influence of ionic effects when modelling meniscus, particularly where fluid flow or localised strain is modelled. From a clinical perspective, it is critical that meniscal regeneration strategies such as scaffolds or allografts attempt to preserve, or compensate for, the function of proteoglycans to ensure normal meniscal function.
Virtual fracture clinics (VFCs) are being increasingly used to offer safe and efficient orthopaedic review without the requirement for face-to-face contact. With the onset of the COVID-19 pandemic, we sought to develop an online referral pathway that would allow us to provide definitive orthopaedic management plans and reduce face-to-face contact at the fracture clinics. All patients presenting to the emergency department from 21March 2020 with a musculoskeletal injury or potential musculoskeletal infection deemed to require orthopaedic input were discussed using a secure messaging app. A definitive management plan was communicated by an on-call senior orthopaedic decision-maker. We analyzed the time to decision, if further information was needed, and the referral outcome. An analysis of the orthopaedic referrals for the same period in 2019 was also performed as a comparison.Introduction
Methods
Hip arthroplasty is considered common to patients aged 65 and over however, both Jennings, et al., (2012) and Bergmann (2016) found THA patients are substantially younger with more patients expecting to return to preoperative activity levels. With heavier, younger, and often more active patients, devices must be able to support a more demanding loading-regime to meet patient expectations. McClung (2000) demonstrated that obese patients can display lower wear-rates with UHMWPE bearing resulting from post-operative, self-induced reduced ambulatory movement, thus questioning if obese kinematics and loading are indeed the worst-case. Current loading patterns used to test hip implants are governed by ISO 14242-1 (2014). This study aimed to characterize a heavy and active population (referred to as HA) and investigate how the gait profile may differ to the current ISO profile. A comprehensive anthropometric data set of 4082 men (Gordon, CC., et.al., 2014) was used to characterize a HA population. Obese and HA participants were classed as BMI ≥30 however HA participants were identified by applying anthropometric ratios indicative of lower body fat, namely “waist to height” (i.e. WHtR <0.6) and “waist to hip” (i.e. WHpR <0.9).Introduction
Method
Accurate and precise acetabular reaming is a requirement for the press-fit stability of cementless acetabular hip replacement components. The accuracy of reaming depends on the reamer, the reaming technique and the bone quality. Conventional reamers wear with use resulting in inaccurate reaming diameters, whilst the theoretical beneficial effect of ‘whirlwind’ reaming over straight reaming has not previously been documented. Our aim was to compare the accuracy and precision of single use additively-manufactured reamers with new conventional reamers and to compare the effect of different acetabular reaming techniques. Forty composite bone models, half high-density and half low-density, were reamed with a new 61 mm conventional acetabular reamer using either straight or ‘whirlwind’ reaming techniques. This was repeated with a 61 mm single use additively-manufactured reamer. Reamed cavities were scanned using a 3D laser scanner with mean diameters of reamed cavities compared using the Mann-Whitney U test to determine any statistically significant differences between groups (p<0.05) [Fig. 1).Aims
Materials and Methods
Performance of metal-on-metal (MOM) bearings was of great interest until recently. Major concerns emerged over high incidence of MOM-wear failures and initially there appeared greater risks with MOM total hip arthroplasty (THA) designs compared to resurfacing arthroplasty (RSA). Impingement of the metal neck against the THA cup was likely the differentiating risk. There is a major difference between RSA and THA in (i) size of femoral necks and (ii) risk of THA metal necks impinging on metal cups. For example, a 46mm THA with 12.5mm neck, a 3.68 head:neck (H/N) ratio, provides a suitably large range-of-motion (ROM). In contrast, an RSA patient with retained 31mm size of natural neck would only have H/N = 1.48, indicating even less ROM than a Charnley THA. However, the enigma is that RSA patients have as good or better ROM in majority of clinical studies. We studied this apparent RSA vs THA dilemma by examining MOM retrievals for signs of adverse impingement. We previously described CoCr stripe wear in failed THA bearings, notably alignment of polar and basal wear stripes coincident with the rim profiles of the cups (Clarke 2013). Our governing hypothesis was that RSA patients had to routinely sublux their hips to get ROM comparable to THA. Our THA impingement studies showed polar stripes within 15o of the polar axis in large heads. For the various RSA diameters, we calculated that wear stripes angled 40o from the femoral axis could indicate impingement with no subluxation, whereas smaller angles would indicate routine subluxation of RSA femoral-shell from cup. We compared explanted RSA (N=15) and THA (N=15) bearings representing three vendors (42–54mm diameters). Wear maps and head-stripes were ink-marked for visualization, photography, and analysis. Wear areas were calculated using spherical equations and wear-stripe angles measured by computer graphics. The results showed that RSA femoral shells had wear areas circular in shape with areas varying 1,085- 3,121mm2. These averaged 14% larger than in matched THA heads but statistically significant difference was not proven. Polar stripes were readily identifiable on femoral components, 75% for RSA cases and 100% for THA. These contained identical linear scratches and all were sited within 30o of neck axis, confirming our hypothesis that RSA patients had to sublux their hips to achieve same motion as THA. Examination of cup wear areas revealed all showed ‘edge-loading’, but RSA cups had a significantly greater degree. Retrieval studies are limited by uncontrolled case sources, varied brands, and small numbers. In this study, we were able to match RSA and THA cases by vendor and diameter. The RSA retrievals revealed polar stripes identical to THA by site, topography and inclination to femoral-neck axis. This confirmed our starting hypothesis and explained the large clinical ROM available in RSA patients. The larger wear areas on RSA femoral shells, although not statistically significant, and the larger ‘edge loading’ sites in RSA cups appeared as further support for routine subluxation of femoral-shells during hip impingement.
Failed total hip arthroplasty (THA) can require novel designs of revision implants that present unique risks as well as benefits. One of our patients endured a series of hip and knee revisions. In her twenties, she experienced a failed THA, became infected and all implants removed. In her early fifties (2008), she had a proximal femoral replacement incorporating a FreedomTM cup (Biomet, Warsaw, IN). She lacked hip musculature, was a dislocation risk, and cup constraint was necessary. Our choice of Freedom cup provided a 36mm head for enhanced stability and range-of-motion, plus the polyethylene liner was not as encompassing as other constrained designs, and the external clamping ring came pre-installed. This unique design allows for ease of head insertion during surgery. Our patient also had a CompressTM fixator combined knee-arthroplasty (Biomet). This knee fixation failed in 2013 and we installed a total femur combined hinge-knee arthroplasty. The Freedom cup was kept and post-op results were satisfactory. Follow-up appeared satisfactory in 2014. Some liner eccentricity was apparent but the patient had no complaints. Radiographs in February 2016 indicated cup's locking-mechanism was possibly failing but patient had no complaints. By December follow-up of 2016, the patient claimed she had 3 falls, and her x-rays indicated a displaced head and dislodged liner. At revision, the liner appeared well-seated inside the acetabular shell. However, about 50% of the polyethylene rim was missing and the large detached circumferential fragment represented the other 50%. A new Freedom liner was installed and her follow-up appears satisfactory to date. The fractured liner was sectioned through the thinnest wall (under detached rim fragment). The most critical design section was at site of the external locking ring, this wall thickness appearing < 3mm, whereas eccentric cup dome was 7.5–8mm thick. Under the detached rim fragment, wall thickness had been reduced (in vivo) to < 1mm. Given the robust rim profile, it seemed unlikely that the liner could have been spinning. The more likely scenario was that with repeated impingement, attempted subluxations by the femoral head stressed the contra- polyethylene rim, resulting in cold flow, thinning, and rim fragmentation. Two exemplar liners were compared, one similar to our patient's and one in a thicker design. Comparison of the sectioned retrieval to the new liners confirmed major loss of circumferential polyethylene. Our learning experience was threefold; (i) if we had been aware of the thin wall limitation, possibly we could have inserted the thicker liner (larger shell), (ii) we could have been more alert to the impending liner failure (x- ray imaging), and (iii) positioning the cup in a more horizontal orientation may have been an alternate solution, i.e. more coverage (but perhaps more impingement). Use of a 32mm head would have facilitated a thicker liner but this option was unavailable. In conclusion, it was notable that this constrained liner functioned very well for 7 years in our complex case and was easily revised at 8 years to another Freedom liner.
Expectations for ceramic-on-metal (COM) bearings included (i) optimal lubrication due to smoother ceramic heads (ii), reduction of metal ions due to elimination of CoCr heads, and (iii) ‘differential hardness’ reducing adhesive wear and squeaking (Firkins 2001, Williams 2007). Additional benefits included (iv) use of heads larger than for ceramic-on-ceramic (COC), (v) reduction in taper corrosion and (vi) simulator studies clearly demonstrated metal ions and wear both reduced compared to MOM (Firkins 2001, Williams 2007, Ishida 2007). However, contemporary ‘3rd body wear’ paradigms focused only on metal debris size range 0.025–0.035um (Firkins 2001). Thus, neglected was the effect of hip impingement, provoking release of large metal particles sized 20–200um (Clarke 2013). In this study, we compared COM retrievals using hypotheses that adverse COM cases would demonstrate a combination of (a) steeply inclined cups, (b) liner “edge-loading”, (c) Ti6Al4V contamination on ceramic, and (d) evidence of 3rd-body CoCr wear by large particles. As a case example, this 51-year old female had her metal-polyethylene (MPE) bearing revised to COM in June 2011. She reported no symptoms 1-year post-op, but scans revealed a palpable mass in the inguinal region of left hip. By March 2013 the patient reported mild pain in her hip, which progressed to severe by April 2014. Scans showed a solid and cystic iliopsoas bursitis while cup position had changed from 43o to 73o inclination. Revision was performed in June 2014, her joint tissues were found extensively stained due to metal contamination, and histology described formation of a large pseudotumor. Analysis of retrieved components was by interferometry, SEM and EDS. Detailed maps were made of wear areas in heads and cups and volumetric wear was determined by CMM techniques. This adverse COM example revealed large diametral mismatch (595um) compared to COM controls (75–115um). The ceramic head had a broad polar stripe of CoCr contamination, roughness 0.1–0.3um high. Equatorial ceramic areas showed arrays of thin metal smears that demonstrated elemental Ti and Al. The CoCr liner revealed wear area into cup rim, as “edge loading”, and also featured a focal rim-defect over 18o circumferential arc. Liner scratches were 20um wide and larger, and wear-rate of CoCr liner averaged approximately 50mm3 per year. In contrast, ceramic head had minimal wear. Our study highlights the underappreciated risk of impingement by metallic prosthetic components. Prior studies of ceramic heads showed black metallic smears. With COM we can anticipate that the broad polar smear will be CoCr alloy (wear of liner on head). However, Ti6Al4V smearing on ceramic heads is a notable signpost indicating impingement by the Ti6Al4V acetabular shell. The femoral neck (Ti6Al4V: CoCr), may also be damaged. Release of large metal particles, 1500-times larger than prior predictions, provoke a particularly adverse ‘3rd body wear’ (Halim, 2015). Such cases confirm our four hypotheses, that COM bearings will then fail in a way similar to MOM. In contrast, COC bearings are immune to such impingement and 3rd-body metal damage.
Metal-on-metal (MOM) and ceramic-on-metal (COM) studies in total hip arthroplasty (THA) documented adverse wear termed “edge loading”. Laboratory simulations necessitated cups steeply inclined to produce edge- loading, whereby cup rims could attenuate the normal wear patterns. Size of cup wear-pattern was therefore key in defining edge-loading. From prior simulator studies (‘Anatomic’ test: ISO-14242), we could demonstrate a linear relationship between size of cup wear-patterns and MOM diameters, cup wear-areas decreasing from 18% to 8%. However, retrieval studies (COM/ MOM) showed cup wear-patterns in vivo were much larger, typically covering 50–55% cup surfaces (Clarke 2013: Koper 2015). In prior MOM Anatomic simulator study (head oscillating, cup fixed), we noted areas worn on 60mm heads and cups averaging 1,668mm2 and 442mm2, respectively (Bowsher 2009). Thus, ratio ×3.77 described distributed area worn on heads relative to focal area worn in cups. In the orbital simulator, the only way to achieve larger cup wear areas was to reverse the component positions, i.e. cups oscillating, heads fixed. The overall goal for this project was to develop an understanding of how such edge-loading affected adverse-wear performance of THA in simulators. 60mm MOM (DJO, Austin TX) were chosen comparable to our prior study (Bowsher 2009) and cups were mounted inverted (oscillating) under fixed heads. Adaptors were machined to incline cup faces at 17o and 27o and, with the simulator's +/−23° motion, they experienced 40oand 50o cyclic peak oscillations, respectively. The orbital simulator was identical to that of prior study as was the test protocol (Bowsher 2009). Wear patterns on components were assessed visually and microscopically, taped and colored red to aid photography. The 40° and 50° tests produced circular cup wear patterns that came progressively closer to the rims without actually producing edge-loading, creating average wear area of 1,663mm2. These proved identical to wear areas on heads (orbiting) in prior Anatomic test (1,668mm2). Using the hemispherical-area datum of 5,655mm2 for 60mm MOM, our test produced cup wear patterns with desired 29.4% coverage. The value of ISTA conferences is that by definition these bring new arthroplasty ideas and technologies to the forefront. The international guideline for simulators (ISO-14242) has proven useful for standard ‘Anatomic’ cup tests that do not require edge-loading conditions. However, ours is the 1st simulator study to; (i) predict the size of THA wear patterns, (ii) show that ratio of head: cup wear-areas average ×3.8 in favor of mobile component, and (iii) demonstrated cups can be run Inverted to produce more clinically-relevant wear patterns that in edge- loading studies. The new learning experience was that studies of edge-loading in THA cups need to consider the ‘Inverted’ test in order to simulate clinically relevant tribo-mechanical parameters. Compared to Anatomic test, the Inverted-cup test has the advantage of (iv) producing larger cup wear areas, (v) clinically-relevant attenuation of wear patterns at cup rim, and (vi) intermittent edge-loading (instead of constant loading) judged likely to apply to a larger patient population at risk.
Hip simulator studies with ceramic-on-metal (COM) predicted less wear than metal-on-metal (MOM: Isaac. 2009). While clinical evidence is scant, two COM case reports described pseudotumors with adverse cup positioning (Deshmukh 2012, Koper 2014). It would appear that our Korean case report is the first to describe pseudotumor formation in well-positioned COM arthroplasty and including detailed failure analysis. A 50-year old female (active salesperson) had bilateral avascular necrosis of her femoral heads. A left metal-on-polyethylene (MPE) hip was performed at outside institution in 2003. At our 3-yrs evaluation, radiographs showed well-functioning MPE hip. Five years later she complained of gradual left-hip pain (2011). Radiographs and CT scan demonstrated wear, osteolysis and loosening of both components. The revision in 2011 was by COM (Fig. 1), using S-ROM stem/sleeve, 36mm ceramic head (Biolox-delta), a CoCr liner and 54mm shell (Pinnacle: Depuy Inc). Cup inclination and anteversion were considered appropriate at 45° and 20° respectively; femoral anteversion of 15° was also appropriate. At 1-yr follow-up patient complained of mild discomfort in left COM hip (2012). Range of motion was painless and normal. Examination revealed a soft, non-tender swelling (2×3cm) in left inguinal region with no inflammation and radiographs were normal (Fig. 1a). One month later the patient complained of left hip pain, the previously noted swelling had increased in size, and she started to limp. Radiographs showed cup migration with increased inclination. CT scans showed a circumscribed lesion extending into iliopsoas region (Fig 2). Serum cobalt and chromium levels were high at 2.4 and 22.5µg/ L, respectively. At revision the pseudotumor and surrounding inflamed synovium was excised. The cystic soft-tissue swelling (stained black) extended into the joint (Fig. 2a). The ceramic head showed a large “black stripe” across the dome (Fig 2b). The cup was loose while the femoral stem was well fixed. Operative cultures of soft tissues and joint fluid were negative for infection while histopathology was consistent for metallosis (Fig. 3). Aggressive debridement was carried out, acetabular defects were filled with bone graft. Revision incorporated 32mm ceramic head (Biolox-delta), highly cross-linked liner and 52mm trabecular-metal shell (Depuy). Functionally the patient has continued to improve. By 6 months, serum ion concentrations decreased to Co:1.3 and Cr:2.54µg/ L with most recent ion levels lower still (Co:0.66 and Cr:0.42µg/ L). Ceramic head surfaces showed normal wear appearance. The large gray stripe identified on the highly polished dome contained Co and Cr metal-transfer from the CoCr liner (Fig. 2b). Thin gray stripes on equatorial head regions (x4 rougher than dome) represented contamination by Ti, Al and V, typical of adverse impingement against Ti6Al4V neck (Clarke 2013). There was a 100–150um defect on rim of CoCr liner as a result of impingement. Cup out-of-roundness was 476um compared to only 7um for ceramic head, thus cup wear dominated at 25–30mm3 volume. This case report was illustrative of the unpredictable and seldom diagnosed risk of habitual cup-to-neck impingement and the risk of relying on pristine simulator studies to predict outcomes in novel THA bearings.
There will be occasions when standards and guidelines stymie the development of new methods. For example, the majority of simulator studies utilized the international guideline specifying that cups will be positioned “Anatomically” (ISO-14242), i.e. acetabular liner is positioned above oscillating femoral head (Fig. 1). This can be disadvantageous for studies of “edge wear” in steeply inclined cups (Williams 2008, Leslie 2009, Angadji 2009). Importantly, such an “Anatomical” cup is fixed with respect to the resultant load-axis (Fig. 1d: R). This produces a constant edge-wear throughout the simulator's cycle. Our supposition was that it is more likely patients experience edge-wear intermittently, i.e. at extremes of motion. This intermittent effect can be best replicated with the cup mounted “Inverted” (Fig. 2), the rotating cam allowing precise selection of edge-wear at extreme of motion (Fig. 2c). An advantage of this method is that the wear-pattern in the orbiting cup is now much larger (Bowsher, 2009: x3.8 ratio), making edge-wear easier to achieve. Our hypotheses were that (1) the Inverted test would provide both “normal” and “edge wear” as defined (Clarke, 2015: steep-cup algorithm), (2) MOM wear rates under edge-wear condition would be greater than in standard simulator tests (Bowsher 2016) and (2) intermittent edge-wear of MOM cups (Inverted) would be less severe than in prior Anatomical tests (Williams 2008, Leslie 2009, Angadji 2009). The 60mm MOM bearings (DJO, Austin TX) were selected on the basis of prior Anatomical study (Bowsher, 2009), were run with cups Inverted, using identical test methods as before, in the orbital simulator. Wear-rates in 60mm heads revealed both run-in and steady-state wear phases (Fig. 3a). The weight-loss method showed perturbations due to protein contaminants but these appeared of minor concern over 10-million cycles. One cup was damaged during set-up, did not recover, and was not included in the analysis (Fig. 3b). Cup wear rates over 10-million cycles appeared very stable with excellent consistency (Fig. 3c). By end of test, the edge-wearing cups averaged 3.7 times higher wear than mating heads. Overall MOM wear averaged 1.6mm3 per million cycles. Apart from the first 100,000 cycles of run-in, no lubricant changed color during entire test. In this first study of its kind, we demonstrated both normal and edge-wear wear-patterns in accordance with predictions of the steep-cup algorithm (Clarke 2015), satisfying hypothesis #1. Wear rates with Inverted cups averaged 2.7 times greater wear than those in similar Anatomical study (Bowsher, 2009), satisfying hypothesis #2. The 60mm MOM wear rates Inverted were mid-range to those in the prior steep-cup Anatomical tests (range 1.3 – 1.9mm3 per 106 cycles). This neither satisfied nor eliminated hypothesis #3, perhaps due to confounding effects, i.e. different designs, MOM diameters and methods. In conclusion, the Inverted test in the simulator appears to offer considerable merit, perhaps analogous to patients who experience edge-wear only intermittently. In contrast the Anatomical test mode appears analogous to patients with mal-positioned cups, who therefore walk on the cup rim constantly throughout their gait cycle.
Despite 46 years clinical experience with ceramic-on-ceramic (COC) hip bearings, there is no data on what constitutes a successful long-term wear performance. There have been many studies of short-term failures (Dorlot, 1992; Nevelos, 2001, Walters, 2004). One retrieval study using optical-CMM technology (OCM) documented volumetric wear-rates ranging up to 7mm3/year on femoral heads (Esposito 2012). It was noted that 83% of these revisions showed stripe damage within 3–4 years. The supposition would appear to be that these were bearing-related failures. Our selected COC case for this study was particularly interesting, a female patient having her index surgery performed at age 17 and revised at age 49 (following onset of hip pain). This patient led an active lifestyle, went dancing multiple times per week, and was mother to three children. The 38mm AutophorTM THA (left hip) was eventually revised due to the cup painful migrating (Fig. 1: 32-years follow-up). Radiographs showed cup inclination at approximately 19°. Impingement marks were noted on the CoCr neck and collared stem (Fig. 2). Implant geometry and form factors were analyzed by standard contour measurement (CMM) while SEM and EDS imaging provided wear topography and evidence of metal contaminants. Linear and volumetric wear in head and cup were studied by OCM at Redlux (Southampton, UK). The head's main wear-pattern consisted of two overlapping circular areas (Fig. 3). The narrowest margin made by the wear-pattern was used to define the superior aspect of the head. By light microscopy, the superior main-wear zone covered 1490–1680mm2 area while the total bi-lobed area covered larger 2170mm2 area. OCM analysis delineated the same bi-lobed appearance of head wear with the superior worn area assessed at 1365mm2. The cup revealed a more extensive wear pattern that circumnavigated its surface. The black staining identified by EDS imaging in the cup revealed Co and Cr elements. By OCM technique the head volumetric wear was 179 mm³ and the cup was 214mm3 (Fig. 4), i.e. 20% greater than head. Volumetric wear-rate averaged 12.3mm3 per year for this pioneering alumina ceramic. This first demonstration of long-term, COC volumetric wear provides the foundation for retrieval and simulator studies alike. Our patient represented a “worst-case” scenario for hip-replacement surgery, due to extreme youth and long-term sporting life. While the superior wear pattern was not totally contained within the cup (Fig. 3), her implant positioning was clearly adequate. Nevertheless both cup edge-wear and CoCr contamination indicated this patient experienced habitual impingement, i.e. alumina cup rim wearing against CoCr femoral neck (Fig. 2). The head wear-pattern was distinctly bi-lobed but OCM images showed the majority of wear was in the superior hemisphere as noted in MOM retrievals (Clarke, 2013). The head wear-rate in this pioneering “Mittelmeier” THA averaged 5.6mm³/year over 32-years of follow-up. This appeared directly comparable to ceramic head wear measured with the same OCM-technique in modern ceramic THA (Esposito, 2012: 0.1 to 7mm3/year). This indicated to us that COC wear rates of the order 10–14mm3/year represented an acceptable “normal” level of performance in young and active individuals.
The treatment of patients with osteoarthritis of the knee and associated extra-articular deformity of the leg is challenging. Current teaching recognises two possible approaches: (1) a total knee replacement (TKR) with intra-articular bone resections to correct the malalignment or (2) an extra-articular osteotomy to correct the malalignment together with a TKR (either simultaneously or staged). However, a number of these patients only have unicompartmental knee osteoarthritis and, in the absence of an extra-articular deformity would be ideal candidates for joint preserving surgery such as unicompartmental knee replacement (UKR) given its superior functional outcome and lower cost relative to a TKR [1). We report four cases of medial unicondylar knee replacement, with a simultaneous extra-articular osteotomy to correct deformity, using novel 3D printed patient-specific guides (Embody, UK) (see Figure 1). The procedure was successful in all four patients, and there were no complications. A mean increase in the Oxford knee score of 9.5, and in the EQ5D VAS of 15 was observed. To our knowledge this is the first report of combined osteotomy and unicompartmental knee replacement for the treatment of extra-articular deformity and knee osteoarthritis. This technically challenging procedure is made possible by a novel 3D printed patient-specific guide which controls osteotomy position, degree of deformity correction (multi-plane if required), and orientates the saw-cuts for the unicompartmental prosthesis according to the corrected leg alignment. Using 3D printed surgical guides to perform operations not previously possible represents a paradigm shift in knee surgery. We suggest that this joint preserving approach should be considered the preferred treatment option for suitable patients.
This study presents an unusual recurrent case of pigmented villonodular synovitis (PVNS) around a ceramic-on-metal (COM) hip retrieved at 9-years. PVNS literature relates to metal-polyethylene and ceramic-ceramic bearings. Amstutz reported 2 cases with MOM resurfacing and Xiaomei reported PVNS recurring at 14 years with metal-on-polyethylene THA. Friedman reported on PVNS recurrence in a ceramic THA. Ours may be the first reported case of recurrent PVNS of a ceramic-on-metal articulation. This young female patient (now 38-years of age) had a total hip replacement in 2006 for PVNS in her left hip. In her initial work-up, this case was presumed to be a pseudotumor problem, typical of those related to CoCr debris with high metal-ion concentrations. She had an CoCr stem (AML), 36mm Biolox-delta head (Ceramtec), and a Pinnacle acetabular cup with CoCr liner (Ultramet, Depuy J&J). This patient had no concerns regarding subluxation, dislocation or squeaking. Three years ago she complained of mild to moderate groin and thigh pain in her left hip. This worsened in the past year. She noticed increased swelling now with an asymmetry to her right hip. She went to the emergency room in Dec-2014 and was referred to a plastic surgeon. In our consult we reviewed MARS-MRI and CT-scans that demonstrated multiple mass lesions surrounding the hip. Laboratory results presented Co=0.7, Cr=0.3 ESR=38 and Crp=0.3. At revision surgery, the joint fluid was hemorrhagic/bloody with hemosiderin staining the soft tissues. Multiple large 4–5×5cm nodules were present in anterior aspect of the hip as well as multiple nodules surrounding posterior capsule and sciatic nerve. Pathology demonstrated a very cellular matrix with hemosiderin-stained tissue and multiple giant cells, which was judged consistent with PVNS. The trunnion showed no fretting, no contamination and no discoloration. The superior neck showed impingement due to low-inclination cup. There was minimal evidence of metal-debris staining the tissues. There was a large metallic-like stripe across the ceramic head. This is a particularly interesting case and may be the first reported recurrent PVNS around a ceramic-on-metal bearing (COM). Data is scant regarding clinical results of COM bearings and here we have a nine-year result in a young and active female patient. She was believed to have a metalosis-related pseudotumor yet her metal-ion levels were not alarmingly high and there was no particular evidence of implant damage or gross wear products. In addition, the CoCr trunnion appeared pristine. Our work-up continues with analyses of wear and histopath-evidence. This case may demonstrate the need for a broadening of the differential diagnosis when dealing with hip failures.
Patient Specific Instrumentation (PSI) has the potential to allow surgeons to perform procedures more accurately, at lower cost and faster than conventional instrumentation. However, studies using PSI have failed to convincingly demonstrate any of these benefits clinically. The influence of guide design on the accuracy of placement of PSI has received no attention within the literature. Our experience has suggested that surgeons gain greater benefit from PSI when undertaking procedures they are less familiar with. Lateral unicompartmental knee replacement (UKR) is relatively infrequently performed and may be an example of an operation for which PSI would be of benefit. We aimed to investigate the impact on accuracy of PSI with respect to the area of contact, the nature of the contact (smooth or studded guide surfaces) and the effect of increasing the number of contact points in different planes. A standard anatomy tibial Sawbone was selected for use in the study and a computed tomography scan obtained to facilitate the production of PSI. Nylon PSI guides were printed on the basis of a lateral UKR plan devised by an orthopaedic surgeon. A control PSI guide with similar dimensions to the cutting block of the Oxford Phase 3 UKR tibial guide was produced, contoured to the anterior tibial surface with multiple studs on the tibial contact surface. Variants of this guide were designed to assess the impact of design features on accuracy. These were: a studded guide with a 40% reduction in tibial contact area, a non-studded version of the control guide, the control guide with a shim to provide articular contact, a guide with an extension to allow distal referencing at the ankle and a guide with a distal extension and an articular shim. All guides were designed with an appendage that facilitated direct attachment to a navigation machine (figure 1). 36 volunteers were asked to place each guide on the tibia with reference to a 3D model of the operative plan. The order of placement was varied using a counterbalanced latin square design to limit the impact of the learning effect. The navigation machine recorded deviations from the plan in respect of proximal-distal and medial-lateral translations as well as rotation around all three axes. Statistical analysis was performed on the compound translational and rotational errors for each guide using ANOVA with Bonferroni correction with statistical significance at p<0.05.Introduction
Method
Use of “CPR” distance has proven clinical utility in stratifying risks of “steep cups” in MOM failures.[1, 4] The CPR indice has been defined as distance between point of intersection of the hip reaction force (Fig. 1: vector-R in contact patch) and closest point on the inner cup rim.[4] However, the CPR indice has limitations. It assumes that, (1) the hip load-vector (R) will be angled 10°-medial in all patients, (2) the contact patch will be same size in all patients, and (3) the contact patch will be invariant with increasing MOM diameter. In contrast it is known from retrieval studies that larger MOM bearings created much larger wear patches.[3] Furthermore, the size of cup wear-patches in MOM bearings can now be estimated with some certainty using simulator wear data.[2] Our objective was to develop an algorithm that would predict (i) contact-patch size for all cup designs and diameters, (ii) determine actual margin of safety (Fig. 1: MOS) for different laterally-inclined cups, and (iii) predict critical test angles for “steep” cup studies in hip simulators. The ‘CPR-distance’ (Fig. 1) is subtended by the CPA angle, but the true margin of safety is the distance from edge of wear patch to cup rim, indicated here by MOS angle. In this algorithm the wear-patch size (CAP angle) is a key parameter, as derived from MOM wear data (Fig. 2). The CAP angles decrease with increasing MOM diameter, as defined by strong linear trend (R=0.998). The key 2nd parameter is cup inclination angle that juxtaposes the wear-pattern to the cup rim (CCI). For hemispherical cups the critical inclination is given by Applicability of the new algorithm can be visualized with a 48mm MOM (cup ABA=160o) run in a standard simulator test (Fig. 3). The algorithm predicts that with cup at 40o inclination there is good margin of safety (11.8o), representing a 5mm distance. This would become much reduced at CIA = 50o, while true edge-wear appears at the 60o test inclination (Fig. 3. EW = −8.2o). For clinical comparison with ‘CPR-distances’, the algorithm shows that positioning the wear patch 10o-medial (Figs. 1, 3) has margin of safety averaging 11.5 mm (MOS) less than was predicted by the CPR indice. While CPR has shown clinical utility, it is believed that compensating for actual size of cup wear-patterns provides a more realistic risk assessment for different MOM diameters in different cup positions. Thus the new algorithm permits accurate depiction of cup wear-patterns for use in both clinical and simulator studies.
Metal-on-metal retrieval studies indicated that MOM wear-rates could rise as high as 60–70mm3/year in short-term failures (Morlock, 2008). In contrast, some MOM and ceramic-on-ceramic (COC) devices of 1970's era performed admirably over 2–3 decades (Schmalzreid, 1996; Shishido, 2003). While technology has aided analysis of short-term MOM and COC failures (Morlock 2008; Lord 2011), information on successful THA remains scant. Lack of long-term data creates difficulties in setting benchmarks for simulator studies and establishing guidelines for use in standards. In this study we compared clinical and wear histories for a 30-year MOM and a 32-year COC to establish such long-term, wear-rates. The McKeeTM retrieval was cemented and made 100% of CoCr alloy (Fig. 1a). This patient had a right femoral fracture at 47 years of age, treated by internal-fixation, which failed. Her revision with a Judet implant also failed, leaving her right hip as a Girdlestone. At the age of 68, she had a McKee THA implanted in left hip, and used it until almost 98 years of age (Campbell, 2003). The COC case was a press-fit AutophorTM THA, head and cup made of alumina ceramic, with the only metal being the CoCr stem (Fig. 1c). This was implanted in a female patient 17-years of age active in sports (water-skiing). This modular THA was revised 32-years later due to hip pain from cup migration. Wear on these implants was identified by stereomicroscopy and stained red for photography (Fig. 1). Cup-to-neck impingement was denoted by circumferential neck notching, roughness was assessed by interferometry, and wear determined by CMM (Lord, 2011). McKee head wear covered 1092mm2 area (Figs. 1a, 2: hemi-area ratio 58%). There was no stripe wear and head roughness was 36nm (Ra). Cup wear covered an area of 1790mm2 (hemi-area 63%). Circumferential damage was noted on the supero-posterior femoral neck with scuff marks also on posterior collar (Fig. 2c). Head and cup wear amounted to 37.7 and 25.2mm3, respectively. Total MOM wear was 62.9mm3, indicating a wear-rate of 2.1mm3/year. Ceramic head wear consisted of two circular patterns (Fig. 1c), the major one of area 1790mm2 (hemi-area 79%). No wear stripes were identified. Non-worn and extensively worn surfaces had roughness (Ra) 17nm and 123nm, respectively. The cup showed 360o circumferential arc of rim wear with a small, non-wear zone inferiorly (Fig. 1c). Gray metallic transfer was evident, EDS revealing Co and Cr (Fig. 3a). Head and cup wear volumes were 77.2 and 54mm3, respectively. Total COC wear amounted to 131.2mm3 indicating a wear-rate of 4.1mm3/year. These two THA functioned successfully over 3 decades. The McKee retrieval had minor signs of impingement but no adverse “stripe wear”. This MOM performed satisfactorily due to good positioning and patient's advanced age (68 to 98Yrs of age). The COC patient was 17 years of age at index surgery and active. The ceramic cup showed 360o of edge wear, CoCr transfer and a COC wear-rate double that of the MOM retrieval. Thus the high ceramic wear-resistance protected this youthful patient.
Explanations for “bearing” noise in ceramic-on-ceramic hips (COC) included stripe-wear formation and loss of lubrication leading to higher friction. However clinical and retrieval studies have clearly documented stripe wear in patients that did not have squeaking. Seldom highlighted has been the risk of metal-on-metal or metal-on-ceramic impingement present in total hip arthroplasty (THA) with metal and ceramic cup designs. The limitation in THA positioning studies has been (i) reliance on 2-dimensional radiographic images and (ii) patients lying supine on the examination table, thus not imaged in squeaking positions. We collected eleven squeaking COC cases for an EOS 3D-imaging functional study. Hip positions were documented in each patient's functional ‘squeaking’ posture using standard and 3-D EOS images for sitting, rising from a chair, hip extension in striding, and single-legged stance. EOS imaging documented for the 1st time that postural dysfunctions with potential impingements were demonstrable for each squeaking case. The 1st major insight in this study came from a female patient who complained of squeaking while walking in flat-soled shoes (Figs. 1a, b). She found that when wearing high-heeled shoes her hip stopped squeaking (Figs. 1c, d). Her lateral EOS view in standing position with heeled shoes revealed that the femoral stem had approximately 3o less hyper-extension compared to flat shoes (Figs. 1b, d, arrows #1,3). The three-dimensional ‘sky-view’ EOS reconstruction of pelvis and femurs (Fig. 2) showed that her femur was also more internally rotated when she wore heels. These subtle shifts in position changed her COC hip from one of squeaking to non-squeaking. A squeaking male patient observed similar postural effects while walking up his boat ramp but not going down the ramp. In both cases, the squeaking was a consequence of cup impinging on a metal femoral neck. Thus the primary cause of squeaking appeared to be hip impingement, i.e. repetitive subluxations that patients generally were not aware of. Another case is representative of situations due to atypical and subtle cup/stem mal-adjustments (Fig. 3); frontal pelvic-tilt, thoracolumbar scoliosis, with 1cm of femur lengthening and a significant increase of offset are observed. Also evident was the femoral-neck retroversion in both standing and sitting. Squeaking occurred when modification of the functional neck orientation occured in one-legged stance (Fig. 3c) or when climbing a stair (Fig. 3d). It was apparent in our EOS studies that patient functionality controlled whether squeaking occurred or not. Thus the new data indicated COC squeaking was a three-fold consequence of component positioning, spine and pelvic adaptions, and variations in patient posture. One limitation here is that our conclusions are based on a small sample of patients and may not be applicable to all. A consequence of such repetitive impingement can be cup rim damage and neck-notching, with release of metal debris. It is well documented that retrieved ceramic bearings are frequently stained black. Thus hip squeaking may likely result from (i) impingement and secondarily (ii) due to ingress of metal particles, and then (iii) producing a failure of lubrication.
The purpose of this study was to determine the survivorship for a MOM implant series performed by a single community surgeon followed using a practical clinical model. A retrospective cohort of 104 primary MOM THA procedures (94 patients) were all performed by one surgeon at three local hospitals now with 10–13 years follow-up. Sixteen patients are deceased and 16 patients have been lost to follow-up. In the remaining 62 patients, 8 are bilateral providing a total of 70 THA for study. The clinical follow-up model included: hip scores, X-rays, ultrasound, and metal ion concentrations (Co, Cr, Ti). Due to the diversity of patient location, a variety of clinical labs were utilized for metal ions. Statistical methods included Kaplan-Meier survival curve and One-way ANOVA. Hip scores were available for 70 THA and of these 61 had a hip score (HHS) above 80 (87%). X-rays were available for 49 hips and of these 38 (78%) had lateral/version angles in the safe zone (Fig 1: inclination ≤ 55 and anteversion ≤ 35). Thirty-eight ultrasound exams were performed and of these three yielded fluid collections (8%). Metal ion concentrations were documented in 39 of 62 patients (63%, either serum or whole blood). Six outliers were identified with high concentrations of metal ions (Fig 2); Co 0.3–143.9 ppb (median 3.6), Cr 0.2–200.3 ppb (median 2.2) and Ti 2-110 ppb (median 54). Six patients were revised by the original surgeon. Three of six with elevated ions were documented as wear problems and the other three were revised for infection, femur fracture and metal-ion sensitivity. The survivorship of 92.5% at 10 years (Fig. 3) may be partly due to the exclusive use of antero-lateral approach performed by one surgeon with 78% of cups well placed and the MOM design used exclusively.
Opening wedge high tibial osteotomy is an attractive surgical option for physically active patients with early osteoarthritis and varus malalignment. Unfortunately use of this surgical technique is frequently accompanied by an unintended increase in the posterior tibial slope, resulting in anterior tibial translation, and consequent altered knee kinematics and cartilage loading(1). To address this unintended consequence, it has been recommended that the relative opening of the anteromedial and posterolateral corners of the osteotomy are calculated pre-operatively using trigonometry (1). This calculation assumes that the saw-cut is made parallel to the native posterior slope; yet given the current reliance on 2D images and the ‘surgeon's eye’ to guide the saw-cut, this assumption is questionable. The aim of this study was to explore how accurately the native posterior tibial slope is reproduced with a traditional freehand osteotomy saw-cut, and whether novel 3D printed patient-specific guides improve this accuracy. 26 fourth year medical students with no prior experience of performing an osteotomy were asked to perform two osteotomy saw-cuts in foam cortical shell tibiae; one freehand, and one with a 3D printed surgical guide (Embody, London) that was designed using a CT scan of the bone model. The students were instructed to aim for parallelity with a hinge pin which had been inserted (with the use of a highly conforming 3D printed guide) parallel to the posterior slope of the native joint. For the purpose of analysis, the sawbones were consistently orientated along their mechanical and anatomical tibial axes using custom moulded supports. Digital photographs taken in the plane of the osteotomy were analysed with ImageJ software to calculate the angular difference in the sagittal plane between the hinge-pin and saw-cut. Statistical analysis was performed with SPSS v21 (Chicago, Illinois); a paired t-test was used to compare the freehand and patient-specific guide techniques. Statistical significance was set at a p-value <0.05.Introduction
Methods
Retrieval studies of metal-on-metal (MOM) resurfaced hips revealed cup “edge wear” as a common failure mechanism [Morlock-2008]. Retrieval analysis of total hip arthroplasty (THA) also demonstrated extensive rim wear (Fig. 1: 190–220o arcs), typically across the superior cup [Clarke-2013]. Such wear patterns have not been demonstrated in hip simulator studies. The simulator “steep cup” models typically had motion arcs (flexion, etc.) input via the femoral head [Leslie-2008, Angadji-2009]. With fixed-inclination cups this produces constant loading of cup rim against the head (Fig. 2a). This is unlikely to be the physiological norm, unless patients walk constantly on the rims of mal-positioned cups. More likely the patients produce edge-wear intermittently due to functional and postural variations. Therefore a novel simulator model is proposed in which the cup undergoes edge-wear intermittently at one extreme of flexion (Fig. 2a). Our study objective using this new simulator model (Fig. 2a, b) was to (i) demonstrate MOM wear-rates and wear patches as a function of these dynamic-inclinations (40 o, 50 o, 70o), and (ii) compare the simulator data to MOM retrievals (Fig. 1). Two simulator studies were run, both using 60mm MOM. Four bearings were run to 1-million cycles (1Mc) with cups peaking at 40 and 50° dynamic-inclinations, thus providing control data with no edge-wear. In 2nd study, 4 MOM were run with cups given a dynamic-inclination of 70° to produce edge-wear effects. In study-2 currently at 2.5Mc duration, the femoral heads showed the two classical wear phases with run-in at 1.7mm³/Mc and steady-state at 0.084mm³/Mc (Fig. 3a). Wear-rate for cups at 2.34mm³/Mc was 40% higher than heads and continued to rise linearly with time (Fig. 3a). At 2.5Mc, cup wear averaged ×5.7 greater than heads and resulting wear-patterns extended 85°−225° around cup rim (Fig. 3b: average 151°). In study-1, wear patches in cups with 40° dynamic-inclination approached within 12.4mm of the cup rim as denoted by circumferential grooves. This margin-of-safety (MOS) represented a 24°angle. The cup wear-patch averaged area of 1,760mm2. With cups run at 70o dynamic-inclination, the wear patches were transferred an additional 30o towards the rim thereby representing a 6° transfer across the rim. This is the 1st wear study to use the new dynamic-inclination test mode to better simulate cup function in vivo. It was particularly satisfying to see the similarity in wear-patterns between retrieval (Fig. 1) and simulator cups (Fig. 3b). It is also the 1st study to monitor sites and magnitudes of cup wear areas and to purposely produce “edge wear”. The cups with 40° and 50° dynamic-inclinations had large margins of safety. With 70° dynamic-inclination the margin of safety was lost - effectively there was a 6° transfer of the wear patch across the cup rim. Even this apparently small effect at one location in each gait cycle sufficiently perturbed MOM performance that wear increased by an order of magnitude. Notably this was all cup wear and not by femoral head participation. The study continues but at 2.5Mc duration the cups revealed 5-fold greater wear than heads.
The knee joint displays a wide spectrum of laxity, from inherently tight to excessively lax even within the normal, uninjured population. The assessment of AP knee laxity in the clinical setting is performed by manual passive tests such as the Lachman test. Non-invasive assessment based on image free navigation has been clinically validated and used to quantify mechanical alignment and coronal knee laxity in early flexion. When used on cadavers the system demonstrated good AP laxity results with flexion up to 40°. This study aimed to validate the repeatability of the assessment of antero-posterior (AP) knee joint laxity using a non-invasive image free navigation system in normal, healthy subjects. Twenty-five healthy volunteers were recruited and examined in a single centre. AP translation was measured using a non-invasive navigation system (PhysioPilot) consisting of an infrared camera, externally mounted optical trackers and computer software. Each of the volunteers had both legs examined by a single examiner twice (two registrations). The Lachman test was performed through flexion in increments of 15°. Coefficients of Repeatability (CR) and Interclass Correlation Coefficients (ICC) were used to validate AP translation. The acceptable limits of agreement for this project were set at 3mm for antero-posterior tibial translation. The most reliable and repeatable AP translation assessments were at 30° and 45°, demonstrating good reliability (ICC 0.82, 0.82) and good repeatability (CR 2.5, 2.9). The AP translation assessment at 0°, 15°, 75° and 90° demonstrated moderate reliability (ICC ≤ 0.75), and poor repeatability (CR ≥3.0mm). The non-invasive system was able to reliably and consistently measure AP knee translation between 30° and 45° flexion, the clinically relevant range for this assessment. This system could therefore be used to quantify abnormal knee laxity and improve the assessment of knee instability and ligamentous injuries in a clinic setting.
Metal-on-metal (MOM) retrieval studies have demonstrated that CoCr bearings used in total hip arthroplasty (THA) and resurfacing (RSA) featured stripe wear damage on heads, likely created by rim impact with CoCr cups.1-3 Such subluxation damage may release quantities of large CoCr particles that would provoke aggressive 3rd-body wear. With RSA, the natural femoral neck reduces the head-neck ratio but avoids risk of metal-to-metal impingement (Fig. 1).4 For this study, twelve retrieved RSA were compared to 12 THA (Table 1), evaluating, (i) patterns of habitual wear, (ii) stripe-wear damage and (iii) 3rd-body abrasive scratches. Considering RSA have head/neck ratios much lower than large-diameter THA, any impingement damage should be uniquely positioned on the heads. Twelve RSA and THA retrievals were selected with respect to similar diameter range and vendors with follow-up ranging typically 1–6 years (Table 1). Patterns of habitual wear were mapped to determine position in vivo. Stripe damage was mapped at three sites: polar, equatorial and basal. Wear patterns were examined using SEM and white light interferometry (WLI). Graphical models characterized the complex geometry of the natural femoral neck in coronal and sagittal planes and provided RSA head-neck ratios.4 Normal area patterns of habitual wear were similar on RSA and THA bearings. The wear patterns showing cup rim-breakout proved larger for RSA cups than THA. Polar stripes presented in juxtaposition to the polar axis in both RSA and THA (Fig. 1). As anticipated, basal stripes on RSA occurred at steeper cup-impingement angles (CIA) than THA. The micro-topography of stripe damage was similar on both RSA and THA heads. Some scratches were illustrative of 3rd-body wear featuring raised lips, punctuated terminuses, and crater-like depressions (Fig. 2). Neck narrowing observed following RSA procedures may be a consequence of impingement and subluxation due to the small head-neck ratios. However, lacking a metal femoral neck, such RSA impingement would not result in metal debris being released. Nevertheless it has been suggested that cup-to-head impingement produced large CoCr particles and also cup “edge wear” as the head orbits the cup rim.4 Our study showed that impingement had occurred as evidenced by the polar stripes and 3rd-body wear by large hard particles as evidenced by the wide scratches with raised lips. We can therefore agree with the prior study, that 2-body and 3rd-body wear mechanisms were present in both RSA and THA retrievals.
Over 40-years the dominant form of implant fixation has been bone cement (PMMA). However the presence of circulating PMMA debris represents a 3rd-body wear mechanism for metal-on-polyethylene (MPE). Wear studies using PMMA slurries represent tests of clinical relevance (Table 1). Cup designs now use many varieties of highly-crosslinked polyethylene (HXPE) of improved wear resistance. However there appears to be no adverse wear studies of vitamin-E blended cups.1–4 The addition of vitamin E as an anti-oxidant is the currently preferred method to preserve mechanical properties and ageing resistance of HXPE. Therefore the present study examined the response of vitamin-E blended liners to PMMA abrasion combined with CoCr and ceramic heads. The hip simulator wear study was run in two phases to compare wear with, (i) clean lubricants and (ii) PMMA slurries. The vitamin-e blended polyethylene liners (HXe+) were provided by DJO Surgical (Austin, TX) with 40mm CoCr and ceramic femoral heads (Biolox-delta). Polyethylene liners were run in standard “Inverted” test. (Table 1) All cups were run in ‘clean’ serum lubricant for 6-million load cycles (6Mc)5 and in a debris slurry (PMMA: 5mg/ml concentration) for 2Mc.4 A commercial bone cement powder was used as “abrasive” (Biomet, Warsaw, IN). PMMA slurries were added at test intervals 6, 6.5, 7 and 7.5Mc.4 Wear was assessed gravimetrically and characterized by linear regression. Bearing roughness was analyzed by interferometry and SEM.Introduction
Methods
Looking for optimal solutions to wear risks evident in total hip arthroplasty (THA), silicon nitride ceramic bearings (Si3N4) are noted for demanding high-temperature applications such as diesel engines and aerospace bearings. As high-strength ceramic for orthopedic applications, Si3N4 offers improved fracture toughness and fracture strength over contemporary aluminas (Al2O3). Our pilot studies of Si3N4 in 28mm diameter THA showed promising results at ISTA meeting of 2007.1 In this simulator study, we compared the wear resistance of 40mm to 28mm diameter Si3N4 bearings. The 28mm and 40mm bearings (Fig. 1) were fabricated from Si3N4 powder (Amedica Inc, Salt Lake City, UT).1 Wear tests run were run at 3kN peak load in an orbital hip simulator (SWM, Monrovia, CA) and. The lubricant was standard bovine serum (Hyclone: diluted to 17 mg/ml protein concentration). Wear was measured by gravimetric method and wear-rates calculated by linear regression. SEM and interferometic microscopic was performed at 3.5-million cycles (3.5Mc) to 12Mc. The simulator was run to 3.5Mc duration with no consistent weight-loss trends. The bearings could show either small positive or negative weight fluctuations in an unpredictable manner (Fig. 2). Surface analysis showed protein layers up to 3μm thick, furrowed due to abrasion by small particles (Fig. 3). The low ceramic wear was camouflaged by protein contaminants alternatively forming and shedding. From 3.5 to 12.8Mc duration we experimented with various detergents and wash-procedures, all to no avail. Protein coatings were also more prevalent on 44 mm heads, likely due to frictional heating by the larger diameter effect. Selected heads were washed with a mild acid solution - the cumulative effect appeared to be removal of some protein layers, but not in a predictable manner. The Si3N4 ceramic is used in demanding industrial applications and it is therefore unfortunate that we are yet not able to quantify the actual wear performance of Si3N4/ Si3N4 bearings (COC). The contaminating protein layers combined with low-wearing silicon nitride obscured the actual wear data. This has also been a problem in prior studies with alumina and zirconia bearings. Considerable challenges still stand in the way of the optimal biomaterials choices that will result in reduced risk of failure while providing extended lifetimes. Thus important issues remain unsolved and call for innovative solutions. Searching for a more effective ‘wear-measurement’ remedy, we noted that abrasive slurries of bone cement (PMMA) used in contemporary simulator studies were effective in promoting adverse wear in polyethylene bearings. These investigations also revealed that PMMA debris did not damage CoCr heads2,3, alumina heads4,5 or diffusion-hardened zirconia heads (ZrDH).6 We can therefore speculate at this ISTA meeting of 2014 that future ceramic wear tests should incorporate PMMA slurries. Here a new hypothesis can be formulated, that PMMA particulates will provide a continual and beneficial removal of contaminating proteins from the ceramic surfaces (see Fig. 3) and thereby aid definition of low-wearing COC bearings such as Si3N4. The application of non-oxide ceramics such as silicon nitride presented here may become a viable alternative for THA designs of next decade.Introduction
Hip simulators proved to be valuable, pre-clinical tests for assessing wear. Preferred implant positioning has been with cup mounted above head, i.e. ‘Anatomical’ (Figs. 1a-c) 1,2 while the ‘Inverted’ test (cup below head) was typically preferred in debris studies (Figs. 1d-f).3,4 In an Anatomical study, wear patterns on cups and heads averaged 442 and 1668 mm² area, respectively, representing 8% and 30% of available hemi-surface (Table 1), i.e. the head pattern was ×3.8 times larger than cup. This concept of wear patterns is illustrated well in the ‘pin-on-disk’ test (Fig. 1) in which the oscillating pin has the ‘contained’ wear area (CWP) and the large wear track on the disk is the ‘distributed’ pattern (DWP). Hip simulators also create CWP and DWP patterns, site dependant on whether Anatomical (Fig. 1a-c) or ‘Inverted’ (Fig. 1d-f) test. However there is scant foundation as to clinical merits of either test mode. Retrieval studies of MOM bearings have indicated that cups have the larger wear patterns, i.e. contrary to simulator tests running Anatomical cups (Table 1).5 Therefore we compared Anatomical and Inverted cup modes using 38mm and 40mm MOM in two 5-million cycle simulator studies. 38mm and 40mm MOM bearings were run in Anatomical mode (study-1) and Inverted (study-2) mode, respectively, in a hip simulator. Lubricant was bovine serum diluted to provide protein concentration 17 mg/ml. Wear was measured gravimetrically and wear-rates calculated by linear regression. Wear patterns were assessed by stereomicroscopy and compared to algorithms using standard spherical equations.Introduction
Methods
The assessment of leg length is essential for planning the correction of deformities and for the compensation of length discrepancy, especially after hip or knee arthroplasty. CT scan measures the “anatomical” lengths but does not evaluate the “functional” length experienced by the patients in standing position. Functional length integrates frontal orientation, flexion or hyperextension. EOS system provides simultaneously AP and lateral measures in standing position and thus provides anatomical and functional evaluations of the lower limb lengths. The objective of this study was to measure 2D and 3D anatomical and functional lengths, to verify whether these measures are different and to evaluate the parameters significantly influencing these potential differences 70 patients without previous surgery of the lower limbs (140 lower extremities) were evaluated on EOS images obtained in bipodal standing position according to a previously described protocol. We used the following definitions: anatomical femoral length between the center of the femoral head (A) and center of the trochlea (B) anatomical tibial length between the center tibial spine (intercondylar eminence) (C) and the center of the ankle joint (D) functional length is AD global anatomical length is AB + CD Other parameters measured are HKA, HKS, femoral and tibial mechanical angles (FMA, TMA), angles of flexion or hyperextension of the knee, femoral and tibial torsion, femoro-tibial torsion in the knee, and cumulative torsional index (CTI). All 2D et3D measures were evaluated and compared for their repeatability.Introduction
Material and Methods
A 35-year-old female (age 35Yrs) had primary MOM total hip arthroplasty (THA) in 2008. At 8 months this patient postoperatively developed headaches, memory loss, vertigo, and aura-like symptoms that progressed to seizures. At 18 months review, she complained of progressive hip pain, a popping sensation and crepitus with joint motion. This patient weighed 284lbs with BMI of 38.5. Radiographs revealed the cup had 55° inclination, 39° anteversion (Fig. 1). Metal ion concentrations were high (blood: Co=126 mcg/L, Cr= 64mcg/L). Revision was performed in November 2010 A dark, serous fluid was observed, along with synovitis. The implants were well fixed and the femoral head could not be removed; thus the stem was removed by femoral osteotomy. With the head fused on this femoral stem, for the 1st time it was possible to precisely determine the habitual patterns of MOM wear relative to her in-vivo function. We investigated (1) size and location of wear patterns and (2) signs of cup-stem impingement to help explain her symptoms developed over 32 months follow-up. The retrieved MOM was a Magnum™ with head diameter 50mm and 50×56mm cup (Biomet). This was mounted on a Taperloc™ lateralized porous-coated stem. Components were examined visually and wear damage mapped by stereo-microscopy, interferometry, CMM, SEM, and EDS. Main-wear zone (MWZ) areas were calculated using standard spherical equations1 and centroidal vectors determined. The head-cup mismatch was 427um with the cup revealing a form factor of 228um. The cup showed wear area of 1275mm² that extended up to the cup rim over 150°arc. The cup rim was worn thin over a 90° arc with loss of cup bevel. The head showed an elliptical wear area of 2200mm2 located centrally on the superior-medial surface (ellipsoidal ratio ×1.2). Compared to the hemispherical surface (50mm: hemi-area = 3927mm2), the worn area represented hemi-area ratio of 56%. The centroidal vectors measured 8° anterior and 24° superior to the head's polar axis (Fig. 2). Stripe wear damage revealed multiple impingement sites. SEM and EDS revealed stripes were contaminated by metal transfer from the stainless-steel instruments used at revision. The main impingement position was identified (Fig. 3) indicating the site of repetitive subluxations whereby the subluxing head thinned the cup, i.e. “edge wear”. Cup and head wear patterns corresponded well, reinforcing our definition of the MWZ locations in vivo. The femoral MWZ was centrally located superiorly and medially with respect to the polar axis of the femoral neck and head. The noted impingement position indicated this patient had experienced repetitive subclinical subluxations (RSS).2 The taper inside the fused head may also have been a contributory factor that we cannot ignore. Nevertheless her excessive cup thinning was likely a result of a steep cup and considerable anteversion allowing the femoral head to sublux over the cup rim, thus thinning the cup and wearing the rim bevel, and producing MOM wear debris.
Coronal misalignment of the lower limbs is closely related to the onset and progression of osteoarthritis. In cases of severe genu varus or valgus, evaluating this alignment can assist in choosing specific surgical strategies. Furthermore, restoring satisfactory alignment after total knee replacement promotes longevity of the implant and better functional results. Knee coronal alignment is typically evaluated with the Hip-Knee-Ankle (HKA) angle. It is generally measured on standing AP long-leg radiographs (LLR). However, patient positioning influences the accuracy of this 2D measurement. A new 3D method to measure coronal lower limb alignment using low-dose EOS images has recently been developed and validated. The goal of this study was to evaluate the relevance of this technique when determining knee coronal alignment in a referral population, and more specifically to evaluate how the HKA angle measured with this 3D method differs from conventional 2D methods. 70 patients (140 lower extremities) were studied for 2D and 3D lower limb alignment measurements. Each patient received AP monoplane and biplane acquisition of their entire lower extremities on the EOS system according the classical protocols for LLR. For each patient, the HKA angle was measured on this AP X-ray with a 2D viewer. The biplane acquisition was used to perform stereoradiographic 3D modeling. Valgus angulation was considered positive, varus angulation negative. Student's T-test was used to determine if there was a bias in the HKA angle measurement between these two methods and to assess the effect of flexion/hyperextension, femoral rotation and tibial rotation on the 2D measurements. One operator did measurements 2 times.Introduction
Materials and methods
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.
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.
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.
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.
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. 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).Introduction
Materials and Methods
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.
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).
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.
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. 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. 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.Material and methods
Results
There is a consensus that impingement, subluxation, and dislocation are major risks that can lead to failure in total hip arthroplasty (1). As well as producing edge-wear, such clinical events also may create additional loads of particulate debris (2). It has been suggested that the release of metal debris with collateral damage on metal-on-metal (MOM) bearings creates a particularly severe abrasive wear, hitherto not understood, and recently termed ‘micro-grooving’ (3,4). Perhaps related to this micro-grooving, large surface depressions have also been observed. These we labeled ‘Dongas’, from the South African term for a steep-sided gully created by erosion. The goal of this study was to examine Dongas found on retrieved MOM bearings and to correlate factors such as cause of revision, MOM diameter and Donga locations with respect to regions of normal and stripe wear. Our hypotheses were: (1) Dongas will be most visible in non-wear zones (NWZ) adjacent to the main-wear zone boundary (MWZ), (2) the 28 mm MOM, being inherently less stable compared to large-diameter MOM, will show a higher Donga frequency and (3) patients with subluxation or dislocation complaints will reveal a higher Donga frequency. Five cases with 28 mm MOM, five of 34–38 mm, and five of 50–56 mm diameter were studied (N = 15). The MWZ was measured in each MOM head and the number of NWZ and MWZ Dongas recorded. Bearing damage was examined using a white-light interferometer (Zygo; 5x lens). Dongas were mainly elliptical in shape, but sometimes highly irregular. They were commonly circumscribed by raised lips (Fig. 1). Donga “trails” were also found, appearing as a linear series of similar-sized Dongas (Fig. 2). Donga trails exhibited some variability with raised lips either lining only the opposite sides or circumscribing most of the perimeter. The Dongas were commonly found in NWZ, with less than 20% found in MWZ. For this set of 15 MOM bearings, large-diameter bearings showed the largest number of Dongas and the greatest frequency of Dongas resulted from either loose or migrating cups. The high occurrence of dongas in the non-wear zone (supporting hypothesis-1) may be a result of particles swept into the bearing interface (2,5). The size of the Dongas and their frequent association to local micro-grooves indicated that these were the impact sites of circulating particles. Such large surface depressions (40–200 μm) have not been described previously and may be unique to MOM bearings (3,4). The observation that Dongas were most prevalent in cases with loose or migrating cups left hypothesis-2 unsatisfied. The much higher incidence of Dongas in the large-diameter MOM was surprising and negated hypothesis-3. Overall these new data relating Dongas and micro-grooves gives new credence to a hitherto unsuspected 3rd-body abrasive wear mechanism due to repetitive subluxation or impingement.
The MOM controversy continues with many prevailing opinions as to the causes of failure in contemporary designs. There has been a great deal of focus on breakdown in fluid-film lubrication with respect to cup positioning and edge wear at its rim. However there has been very little discussion on the problems of 3rd body abrasion. In only one study was there a description of unusually large abrasive marks on retrieved femoral heads (McKee Farrar MOM), revealing 100 μm wide scratches, attributed to circulating particles fractured during impingement episodes. With contemporary MOM devices, there is the potential for abrasion by particulates of CoCr, PMMA and Ti6Al4V. However it has been difficult to formulate a coherent simulator model for 3rd-body abrasive wear, given the unpredictable nature of impingement damage releasing abrasive particles into the patient's hip joint. Thus this study sought to identify if metal or cement particulates were capable of creating 100 μm wide scratches as seen on retrieved MOM and develop a simulator model for 3rd body abrasive testing on MOM bearings. Six 38 mm CoCrMo bearings (DJO Inc., Texas) were run in a12-station hip simulator (SWM, Monrovia, CA) with cups mounted both anatomically and inverted (3 MOM each). The tests were 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. 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. The simulator was run for only 10 cycles and the MOM parts removed for study. All bearings were ultrasonically cleaned and heads were examined using white light interferometry (WLI, Zygo Corp). Grooves were characterized using surface profiles to measure width, depth, and rim height. SEM imaging (EVO MA15, Zeiss) and EDS imaging (X flash detector 4010, Bruker AXS) was performed in areas of grooving and suspected transfer layers. CoCr debris produced broad, curvilinear grooves with widths ranging from 20–170 μm, depths from 0.3–1.5 μm, raised rims, longitudinal striations and chatter marks. Titanium alloy debris produced arrays of very shallow scratches accompanying larger grooves. These larger grooves measured 20–110 μm wide and 0.4–1.9 μm deep. EDS imaging showed the smears and islands contained the elements Ti, Al and V representative of the Ti6Al4V alloy. WLI imaging showed these metal deposits (250–900 um wide) were raised >10 um above the surface. Particularly conspicuous was evidence of considerable smearing on CoCr surfaces, with linear streaks ranging 150–300 μm wide. Bone cement debris proved incapable of grooving the CoCr surface, the only scratches observed were those comparable to normal carbide scratches.
Femoral stem anteversion after total hip arthroplasty (THA) has always been assessed using CT scan in supine position. In this study, we evaluated the anteversion of the femoral prosthesis neck in functional standing position using EOS® technology with repeatability and reproducibility of the measurements. The data obtained were compared with conventional anatomic measurements. We measured the anteversion of the femoral prosthesis neck in 45 consecutive patients who had THA performed in nine hospitals. All measurements were obtained using the EOS® imaging system with patients in comfortable standing position. The orientation of the final vector representing the femoral neck was measured on 3-dimensional reconstructions. The anatomic femoral anteversion was calculated as in a transverse plane relative to the scanner and to the plane of the reconstructed bicondylar femoral segment (femoral prosthesis neck against the femoral condyles). Functional femoral anteversion (FFA) was measured in the horizontal plane relative to the frontal plane of the patient through the center of two femoral heads. FFA embodies true anteversion of the femoral prosthesis neck relative to the pelvis, representing the combined lower extremity anteversion.Introduction
Materials and Methods
In an effort to understand the role of metal ion analysis and how it relates to revision surgery and implant wear, four revised MOM cases were reviewed. The first case was revised for acute infection and is representative of the low bearing wear predicted by MOM simulator studies. Two of the four cases had apparent anterior subluxation as a result of hip hyperextension occurring with long stride gaits. The last case is a true hypersensitivity response to CoCr ions. All four MOM prostheses were implanted by one surgeon and revised by the same surgeon approximately 6–8 years postoperatively. The implants had been positioned satisfactorily with inclination angles 45°–55° and anteversion angles 28°–42°. Patient A (76 y/o female) with bilateral MOM hip replacements, was revised at approximately 8 years due to infection and had moderately elevated ions at the time of revision surgery (Co = 5, Cr = 2.3, Ti = 4). Only the femoral head was retrieved in this case. Retrieval analysis identified a well defined main-wear zone and one polar stripe. The CMM indicated there was minimal wear overall (form factor = 11 μm). Patient B (33 y/o male) with bilateral MOM hip replacements, was revised at approximately 8 years due to pain, popping/catching sensations, and elevated ions (Co = 33, Cr = 17, Ti = 90). Intraoperatively, the implant was observed subluxing superiorly from the acetabular cup with anterior rotation of the leg. Both the femoral head and acetabular cup were retrieved. Retrieval analysis identified a well defined main-wear zone and multi-directional polar stripe formations similar to those reported on dislocated implants (Figure 1)[McPherson 2012, 2013]. The CMM indicated that overall wear was significant (form factor > 100 μm). Patient C (77 y/o female) was revised at approximately 6 years due to pain, suspected implant loosening, osteolytic cysts determined by CT, and highly elevated ions (co = 164, Cr = 45, Ti = 33). Intraoperatively, there was evidence of wear including darkly stained tissue and osteolytic cysts. Both the femoral head and acetabular cup were retrieved. Retrieval analysis identified a well defined main-wear zone and one polar stripe. CMM indicated considerable wear (head form factor > 200, cup form factor >300). Patient D (45 y/o female) was revised at approximately 6 years due to pain, apparent reactive response joint effusion, and moderately elevated ions (Co = 5, Cr = 6, Ti = 71). Only the femoral head was retrieved. Retrieval analysis identified a well defined main-wear zone and one polar stripe. Minimal wear was indicated by CMM (form factor = 21). These four cases demonstrate distinct failure models of MOM hips and their respective metal ion results. Due to the diversity of patient location, a variety of clinical labs were utilized for this patient population. Caution should be used in interpreting metal ion analysis, as there are still no standards. Figure 1: Retrieval analysis of stripe wear identified on femoral head from patient B. Figure 2: Femoral head from patient C showing broader polar stripe associated with anterior subluxation in comparison to narrow polar stripe found on femoral head from patient A.
CT based systems that are used to create custom components and custom cutting guides in total knee arthroplasty (TKA) have variable methods for accounting for the thickness of remaining cartilage that may influence component sizing and bone resection. Little information has been published about the thickness of this cartilage, especially on the posterior femoral condyles. Failure to account for this cartilage may lead to under-sizing of the femoral component, or a reduction in the posterior condylar offset that may adversely affect flexion after TKA. This IRB approved, retrospective study included 140 consecutive patients who underwent primary TKA. The medial and lateral posterior condylar bone cuts were performed in the usual manner with mechanical instruments. The resected specimen was sectioned in the sagital plane and the cartilage thickness was measured at the mid portion to the nearest millimeter.Introduction
Methods
While prosthesis survival in Total Knee Arthroplasty (TKA) exceeds 90% at 10 year, failures do occur. One area of concern has been the potential for metal allergy or metal sensitivity causing persistent pain, swelling or early failure of the implant in some patients. Definitive tests for diagnosing metal allergy and metal sensitivity have not been developed and this field remains controversial. In most cases where metal sensitivity is a concern, metals such as Chromium and Nickel are implicated. Despite the lack of good diagnostic tests for identifying these patients, several orthopedic prosthesis manufacturers have developed implants made of Titanium or ceramic designed for use in patients where concerns exist regarding metal allergy. In the absence of good diagnostic tests, use of these devices in patients that self identify is one option. To date, little information has been presented about the incidence of self reported metal sensitivity in patients undergoing joint replacement. This study was undertaken to determine the incidence of self reported metal allergy or sensitivity in patients undergoing total knee arthroplasty. An IRB approved, retrospective chart review was performed in a consecutive series of 194 patients who had undergone TKA at one institution, with one surgeon. Self reported metal sensitivity and allergy had been routinely elicited from each individual who had not undergone implantation of a previous metallic device, during pre-operative consultation.Introduction
Methods
Patellar resurfacing during Total Knee Arthroplasty (TKA) is controversial. Problems unique to patellar resurfacing may be influenced by available patellar component design. These issues include; over-stuffing (the creation of a composite patellar-prosthesis thickness greater than the native patella) that may contribute to reduced range of motion; and over-resection of the native patellar bone that may contribute to post-operative fracture. Prosthesis design may play a role in contributing to these problems. Component diameter and thickness are quite variable from one manufacturer to another and little information has been previously published about optimal component dimensions. This anatomic study was performed to define the native patellar anatomy of patients undergoing TKA, in order to guide future component design. This retrospective, IRB approved study reviewed 797 Caucasian knees that underwent primary TKA by a single surgeon. Data recorded for each patient included: gender; patellar thickness before and after resurfacing, and the size of the component that provided the greatest patellar coverage without any overhang. The residual patellar bone thickness after resection was also calculated.Introduction
Methods