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The Bone & Joint Journal
Vol. 104-B, Issue 3 | Pages 376 - 385
1 Mar 2022
Gramlich Y Hofmann L Kress S Ruckes C Kemmerer M Klug A Hoffmann R Kremer M

Aims. This study compared the cobalt and chromium serum ion concentration of patients treated with two different metal-on-metal (MoM) hinged total knee arthroplasty (TKA) systems, as well as a titanium nitride (TiN)-coated variant. Methods. A total of 63 patients (65 implants) were treated using either a MoM-coated (n = 29) or TiN-coated (n = 7) hinged TKA (GenuX mobile bearing, MUTARS; Implantcast, Germany) versus the BPKS (Brehm, Germany) hinged TKA (n = 27), in which the weight placed on the MoM hinge is diffused through a polyethylene (PE) inlay, reducing the direct load on the MoM hinge. Serum cobalt and chromium ion concentrations were assessed after minimum follow-up of 12 months, as well as functional outcome and quality of life. Results. No differences in mean age (69 years, 40 to 86), mean age adapted Charlson Comorbidity Index (3.1 (SD 1.4)), mean BMI (29.2 kg/m. 2. (SD 5.8)), or number of other implants were observed between groups. Significant improvements in outcome scores and pain levels were achieved for all groups, and there was no difference in quality of life (12-Item Short-Form Health Survey questionnaire (SF-12)). Mean cobalt and chromium ion levels were significantly higher for the GenuX versus the BPKS hinged TKA (GenuX vs BPKS: cobalt: 16.3 vs 9.4 µg/l; chromium: 9.5 vs 5.2 µg/l). The TiN-coated implants did not appear to confer improvement in the metal ion levels. Metal ion concentrations above 7 µg/l were detected in 81%(29/36) of GenuX patients versus 41% (11/27) in the BPKS group. No GenuX patients had normal levels under 2 µg/l, versus 22% of BPKS patients. No significant reduction in outcome scores was observed regardless of the metal ion levels, whereas higher work-related activity was correlated with higher chromium concentrations. Conclusion. Hinged TKA, using MoM hinges, resulted in critically high cobalt and chromium ion concentrations. The BPKS hinged TKA showed significantly lower metal ion concentrations compared with the GenuX TKA. No benefits were observed using TiN coating. The different weightbearing mechanics might influence the wear of the component materials. Higher workloads and physical activity could influence chromium levels. Cite this article: Bone Joint J 2022;104-B(3):376–385


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 51 - 51
1 Oct 2020
Wooster BM Kennedy NI Mallet KE Taunton MJ Abdel MP Trousdale RT
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Introduction. Mechanical or corrosive failure of total knee arthroplasties (TKAs) is difficult to diagnose with current laboratory and radiographic analyses. As such, the goal of this study was to determine the mean blood concentration of cobalt, chromium, and titanium in a series of revision TKAs with mechanical implant failure and evaluate whether they facilitated identification of the underlying TKA failure mechanism. Methods. Serum cobalt, chromium, and titanium levels and synovial fluid characteristics were evaluated in 12 patients (13 aseptic revision TKAs) who underwent revision TKA between 2000 and 2020 at a single academic institution for mechanical implant failure or corrosion. Seventy-five percent were re-revisions of previously revised TKAs. Mean time to revision was 6 years. Modular metallic junctions were present in 100%. Twenty-five percent did not have another in situ total joint arthroplasty, and the remaining patients did not have a metal-on-metal articulation that could lead to elevation in serum metal ion levels. Mean follow-up after the revision TKA was 8 months. Results. Mean serum cobalt, chromium, and titanium concentrations were 11 ng/mL, 6 ng/mL, and 3 ng/mL, respectively. Serum metal ion levels facilitated failure mechanism identification in 75%, which included modular junction failure (6 cases), constraint locking mechanism failure (3 cases), corrosion of modular metallic interfaces (2 cases), and implant fracture (1 case). Arthrocentesis was performed in 75%. Mean synovial fluid cell count was 950 cells/mcL. Monocytes were the predominant mean cell type (41%), followed by neutrophils (35%), and lymphocytes (22%). Conclusion. Serum metal ion assessment should be considered when the etiology of painful primary or revision TKAs, particularly those with modular metallic junctions, remains elusive after routine evaluation


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 5 | Pages 634 - 638
1 May 2010
Savarino L Tigani D Greco M Baldini N Giunti A

We investigated the role of ion release in the assessment of fixation of the implant after total knee replacement and hypothesised that ion monitoring could be a useful parameter in the diagnosis of prosthetic loosening. We enrolled 59 patients with unilateral procedures and measured their serum aluminium, titanium, chromium and cobalt ion levels, blinded to the clinical and radiological outcome which was considered to be the reference standard. The cut-off levels for detection of the ions were obtained by measuring the levels in 41 healthy blood donors who had no implants. Based on the clinical and radiological evaluation the patients were divided into two groups with either stable (n = 24) or loosened (n = 35) implants. A significant increase in the mean level of Cr ions was seen in the group with failed implants (p = 0.001). The diagnostic accuracy was 71% providing strong evidence of failure when the level of Cr ions exceeded the cut-off value. The possibility of distinguishing loosening from other causes of failure was demonstrated by the higher diagnostic accuracy of 83%, when considering only patients with failure attributable to loosening. Measurement of the serum level of Cr ions may be of value for detecting failure due to loosening when the diagnosis is in doubt. The other metal ions studies did not have any diagnostic value


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 14 - 14
7 Aug 2023
Langton D Bhalekar R Wells S Nargol M Haston S Natu S Nargol A
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Abstract. Introduction. Several studies have reported significant cobalt(Co) and chromium(Cr) elevations in the blood of patients with total-knee-replacements (TKRs), and histological signs of metal sensitivity have been reported in up to 44% of patients undergoing revision of their TKRs. We carried out this investigation to determine the source and quantity of metal release in TKRs. Methodology. We identified all TKRs with polished CoCr trays (N=59) [Vanguard=29, Attune=4 and PFC=26]. These were analysed using peer-reviewed [coordinate-measuring-machine (CMM)] methodology to measure the volumetric wear of the polyethylene (PE) bearing surfaces and trays. The trays were analysed using 2D-profilometry (surface roughness-Ra) and 4D-microscopy. Histological and blood metal ion concentration analyses were performed. Results. The median(IQR) PE wear rate was 10(6to20) mm3/year. Microscopic analysis identified pitting on superior surface of 36(49%) trays. Ra [median (IQR)] of superior surface of pitted trays [0.076 (0.060–0.084) µm] showed a statistically significant increase (p<0.001) compared with unpitted trays [0.057(0.049–0.066) µm]. 4D-microscopy and CMM analysis estimated wear volumes of up to 2mm3 secondary to pitting. The median (range) Co and Cr concentrations were 2.5µg/l (0.2–69.4) and 1.7µg/l (0.5–12.5) respectively in 40 patients. Of the tissue samples examined in 30 patients,6 had at-least “mild”-ALVAL infiltrate. All corresponding “ALVAL” explants were found to be pitted and/or show evidence of loosening of the tray. Conclusion. This study provides further evidence that CoCr release in TKR appears to be an under-recognised cause of adverse clinical outcomes. Gross metal ion elevations occurred in association with micromotion/loosening of the tray


The Bone & Joint Journal
Vol. 101-B, Issue 2 | Pages 227 - 232
1 Feb 2019
Walker T Rutkowski L Innmann M Panzram B Herre J Gotterbarm T Aldinger PR Merle C

Aims. The treatment of patients with allergies to metal in total joint arthroplasty is an ongoing debate. Possibilities include the use of hypoallergenic prostheses, as well as the use of standard cobalt-chromium (CoCr) alloy. This non-designer study was performed to evaluate the clinical outcome and survival rates of unicondylar knee arthroplasty (UKA) using a standard CoCr alloy in patients reporting signs of a hypersensitivity to metal. Patients and Methods. A consecutive series of patients suitable for UKA were screened for symptoms of metal hypersensitivity by use of a questionnaire. A total of 82 patients out of 1737 patients suitable for medial UKA reporting cutaneous metal hypersensitivity to cobalt, chromium, or nickel were included into this study and prospectively evaluated to determine the functional outcome, possible signs of hypersensitivity, and short-term survivorship at a minimum follow-up of 1.5 years. Results. At a mean follow-up of three years (1.5 to 5.7), no local or systemic symptoms of hypersensitivity to metal were observed. One patient underwent revision surgery to a bicondylar prosthesis due to a tibial periprosthetic fracture resulting in a survival rate of 98.8% (95% confidence interval (CI) 91.7 to 99.8; number at risk, 28) at three years with the endpoint of revision for any reason and a survival rate of 97.6% (95% CI 90.6 to 99.3; number at risk, 29) for the endpoint of all reoperations. Clinical outcome was good to excellent with a mean Oxford Knee Score of 42.5 (. sd. 2.5; 37 to 48). Conclusion. This study is the first demonstrating clinical results and survival analysis of UKA using a CoCr alloy in patients with a history of metal hypersensitivity. Functional outcome and survivorship are on a high-level equivalent to those reported for UKA in patients without a history of metal hypersensitivity. No serious local or systemic symptoms of metal hypersensitivity could be detected, and no revision surgery was performed due to an adverse reaction to metal ions


The Bone & Joint Journal
Vol. 98-B, Issue 4 | Pages 437 - 441
1 Apr 2016
Middleton S Toms A

We explored the literature surrounding whether allergy and hypersensitivity has a clinical basis for implant selection in total knee arthroplasty (TKA). In error, the terms hypersensitivity and allergy are often used synonymously. Although a relationship is present, we could not find any evidence of implant failure due to allergy. There is however increasing basic science that suggests a link between loosening and metal ion production. This is not an allergic response but is a potential problem. With a lack of evidence logically there can be no justification to use ‘hypoallergenic’ implants in patients who have pre-existing skin sensitivity to the metals used in TKA. Cite this article: Bone Joint J 2016;98-B:437–41


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 1 - 1
1 Oct 2020
Springer B Haddad FS
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The COVID-19 pandemic has led to unprecedented times worldwide. From lockdowns to masks now being part of our everyday routine, to the halting of elective surgeries, the virus has touched everyone and every part of our personal and professional lives. Perhaps, now more than ever, our ability to adapt, change and persevere is critical to our survival. This year's closed meeting of The Knee Society demonstrated exactly those characteristics. When it became evident that an in-person meeting would not be feasible, The Knee Society leadership, under the direction of President John Callaghan, MD and Program Chair Craig Della Valle, MD created a unique and engaging meeting held on September 10–12, 2020. Special recognition should be given to Olga Foley and Cynthia Garcia at The Knee Society for their flexibility and creativeness in putting together a world-class flawless virtual program. The Bone & Joint Journal is very pleased to partner with The Knee Society to once again publish the proceedings of the closed meeting of the Knee Society. The Knee Society is a United States based society of highly selected members who have shown leadership in education and research in knee surgery. It invites up to 15% international members; this includes some of the key opinion leaders in knee surgery from outside the USA. Each year, the top research papers from The Knee Society meeting will be published and made available to the wider orthopaedic community in The Bone & Joint Journal. The first such proceedings were published in BJJ in 2019. International dissemination should help to fulfil the mission and vision of the Knee Society of advancing the care of patients with knee disorders through leadership, education and research. The quality of dissemination that The Bone & Joint Journal provides should enhance the profile of this work and allow a larger body of surgeons, associated healthcare professionals and patients to benefit from the expertise of the members of The Knee Society. The meeting is one of the highlights of the annual academic calendar for knee surgeons. With nearly every member in attendance virtually throughout the 3 days, the top research papers from the membership were presented and discussed in a virtual format that allowed for lively interaction and discussion. There are 75 abstracts presented. More selective proceedings with full papers will be available after a robust peer review process in 2021, both online and in The Bone & Joint Journal. The meeting commenced with the first group of scientific papers focused on Periprosthetic Joint Infection. Dr Berry and colleagues from the Mayo Clinic further help to clarify the issue of serology and aspirate results to diagnose TKA PJI in the acute postoperative setting. 177 TKA's had an aspiration within 12 weeks and 22 were proven to have PJI. Their results demonstrated that acute PJI after TKA should be suspected within 6 weeks if CRP is ≥81 mg/L, synovial WBCs are ≥8500 cells/μL, and/or synovial neutrophils≥86%. Between 6– 12 weeks, concerning thresholds include a CRP ≥ 32 mg/L, synovial WBC ≥7450, and synovial neutrophils ≥ 84%. While historically the results of a DAIR procedure for PJI have been variable, Tom Fehring's study showed promise with the local delivery of vancomycin through the Intraosseous route improved early results. New member Simon Young contrasted the efficacy of the DAIR procedure when comparing early infections to late acute hematogenous PJI. DAIR failed in 63% of late hematogenous PJIs (implant age>1 year) compared to 36% of early (<1year) PJIs. Dr Masri demonstrated in a small group of patients that those with well-functioning articulating spacers can retain their spacers for over 12 months with no difference in infection from those that had a formal two stage exchange. The mental toll of PJI was demonstrated in a longitudinal study by Doug Dennis, where patient being treated with 2 stage exchange had 4x higher rates of depression compared to patient undergoing aseptic revision. The second session focused on both postoperative issues with regards to anticoagulation and manipulation. Steven Haas demonstrated high complication rates with utilization of anticoagulation for treatment of postoperative pulmonary embolism with modern therapeutic anticoagulation (warfarin, enoxaparin, Xa inhibitors) with the Xa inhibitors demonstrating lower complication rates. Two papers focused on the topic of manipulation. Mark Pagnano presented data on timing of manipulation under anesthesia up to even past 12 months. While gains were modest, a subset of patients did achieve substantial gains in ROM > 20degrees even after 3 months post op. Dr Westrich's study demonstrated no difference in MUA outcomes with either IV sedation or neuraxial anesthesia although the length of stay was shorter in the IV sedation group. Several studies in Session II focused on kinematics and femoral component position. Dr Li's in vivo kinematic study during weightbearing flexion and gait demonstrated that several knees rotated with a lateral pivot motion and not all knees can be described with a single motion character. Dr Mayman and his group utilized a computational knee model to demonstrate that additional distal femoral resection results in increasing levels of mid -flexion instability and cautioned against the use of additional bony resection as the first line for flexion contractures. Using computer navigation, Dr Huddleston's study nicely outlined the variability in femoral component rotation to achieve a rectangular flexion gap utilizing a gap balanced method. The third session opened the meeting on Friday morning. The focus was on unicompartmental knee arthroplasty and the increasing utilization of robotic assisted total knee arthroplasty. David Murray showed using registry data that for patient with higher comorbidities (ASA >3), UKA was safer and more cost effective than TKA while Dr Della Valle's group demonstrated overall lower average healthcare costs in UKA patients compared to TKA in the first 10 years after surgery. Dr Geller assessed UKA survivorship among 3 international registries. While survivorship varied by nation and designs, certain designs consistently had better overall performance. Dr Nunley and his group showed robotic navigation UKA significantly reduced outliers in alignment and overhang compared to manual UKA. Dr Catani's data demonstrated that full thickness cartilage loss should still be considered a requirement for UKA success even with robotic assistance. Despite a high dislocation rate of 4%, Mr Dodd demonstrated high survivorship for lateral UKA despite historical contraindications. The growing evidence for robotics TKA was demonstrated in two studies. Professor Haddad showed less soft tissue injury, reduced bone trauma and improved accuracy or rTKA compared to manual TKA while Dr Gustke single surgeon study showed his rTKA had improved forgotten joint scores and less ligament releasing required for balancing. Despite these finding, Dr Lee's study demonstrated that a robotic TKA could not guarantee excellent pain relief and other factors such a patient expectations and psychological factors play a role. Our fourth session was devoted to machine learning and smart tools and modeling. Dr Meneghini used machine learning algorithms to identify optimal alignment outcomes that correlated with patient outcomes. Several parameters such as native tibial slope, femoral sagittal position and coronal limb alignment correlated with outcomes. Along the same lines, Bozic and coauthors demonstrated that using AI algorithms incorporated with PROM's improved levels of shared decision making and patient satisfaction. Dr Lombardi demonstrated that a mobile patient engagement platform that provided smart phone-based exercise and education was comparable to traditional methods. Dr Mahfouz demonstrated the accuracy of using ultrasound to produce 3D models of the bone compared to conventional CT based strategies and Dr Mahoney showed the valued of a preop 3D model in reproducing more normal knee kinematics. The last two talks of the session focused on some of the positives of the COVID-19 pandemic, namely the embracing of telemedicine by patients and surgeons as demonstrated by Dr Slover and the increasing and far reaching educational opportunities made available to residents and fellows during the pandemic. Session five focused on risk stratification and optimization prior to TKA. Dr O'Connor demonstrated that that the implementation of an optimization program preoperatively reduced length of stay and ED visits, and Charles Nelson's study showed that risk stratification tool can lower complication rates in obese patients undergoing TKA comparable to those that are nonobese. Dr Markel's study demonstrated that those who have preoperative depression and anxiety are at higher risk of complications and readmissions after surgery and these issues should be addressed preoperatively. Interestingly, a study by Dr Callaghan demonstrated that care improvement pathways have not lowered the gap in complications for morbidly obese patients undergoing TKA, Dr Barsoum argued that the overall complication rates were low and this patient cohort had significant gains in PROMS after TKA that would not be experienced if arbitrary cutoff for limited surgery were established. The final session on Friday, Session six, had several well done and interesting studies. There continues to be mounting evidence that liposomal bupivacaine has little effect on managing post-operative pain to warrant its increased use. Bill Macaulay and colleagues showed no change in pain scores, opioid consumption and functional scores when liposomal bupivacaine was discontinued at a large academic medical center. Dr Bugbee importantly demonstrated that a supervised ambulation program reduced falls in the early postoperative period. Several paper on healthcare economics were presented. Rich Iorio showed that stratifying complexity of total joint cases between hospitals with a system can be efficient and cost savings while Dr Jiranek demonstrated in his study that complex TKAs can be identified preoperatively and are associated with prolonged operative time and cost of care and consideration should be given in future reimbursement models to a complexity modifier. Dr Springer, in their evaluation of Medicare bundled payment models, demonstrated that providers and hospitals in historical bundled models that became efficient were penalized in the new model, forcing many groups to drop out and return to a fee for service model. Ron Delanois important work showed that social determinants can have a major negative impact on outcomes following TKA. Our final day on Saturday opened with Session seven, and several interesting paper on metal ions/debris in TKA. Dr Whitesides simulator study showed the absence of scratches and material loss in a ceramic TKA compared with Co-Cr TKA and suggested an advantage to this material in patients with metal sensitivity. Conversely, in a histological study of failed TKA, perivascular lymphocytic infiltration was not associated with worse clinical outcomes or differences in revision in a series of 617 aseptic revisions, 19% of which had PVLI found on histology. The Mayo group and Dr Trousdale however, noted that serum metal ion levels can be helpful in identifying implant failure in a group of revision TKAs, especially those with metallic junctions. Dr Dalury demonstrated nicely that use of maximally conforming inserts did not have a negative effect on implant loosening in a series of 76 revision TKA's at an average follow up of 7 years, while Kevin Garvin and his group showed no difference in end of stem pain between cemented and cementless stems in revision TKA. The final two studies in the session by Bolognesi and Peters respectively showed that metaphyseal cones continue to demonstrate excelled survivorship in rTKA setting despite extensive bone loss. Session eight was highlighted by a large series of revision reported by new member Dr Schwarzkopf, who showed that revision TKA done by high volume surgeons demonstrated better outcomes and lower revision rates compared to surgeon who did less than 18 rTKA's per year. Dr Maniar importantly showed that preoperatively, patients with high activity level and low pain and indicated by a high preop forgotten joint score did poorly following TKA while David Ayers nicely demonstrated that KOOS scores that assess specific postoperative outcomes can predict patient dissatisfaction after TKA. The final paper in this session by Max Courtney showed that the majority of surgical cancellations are due to medical issues, yet a minority of these undergo any intervention specifically for that condition, but they resulted in a delay of 5 months. The first two studies of Session nine focused on polyethylene thickness. Dr Backstein demonstrated no difference in KSS scores, change in ROM and aseptic revision rates based on polyethylene thickness in a series of 195 TKA's. An interesting lab study by Dr Tim Wright showed a surprising consistency in liner thickness choice among varying levels of surgeon experience that did not correlate with applied forces or gap stability estimates. Two studies looked specifically at the issue of tibial loosening and implant design. Nam and colleagues were not able to demonstrate concerning findings for increasing tibial loosening in a tibial baseplate with a shortened tibial keel at short term follow up, while Lachiewicz demonstrated a 19% revision or revision pending rate in 223 cemented fixed bearing ATTUNE TKA at a mean of 30 months. Our final session of the meeting, began with encouraging news, that despite only currently capturing about 40% of TJA's done in the US, the American Joint Replacement Registry data is representative of data in other representative US databases. An interesting study presented by Robert Barrack looked at bone remodeling in the proximal tibia after cemented and cementless TKA of two different designs. No significant difference was noted among the groups with the exception of the cemented thicker cobalt chrome tray which demonstrated significantly more bone mineral density loss. Along the same lines, a study out of Dr Bostrom's lab demonstrated treatment of a murine tibial model with iPTH prevents fibrous tissue formation and enhances bone formation in cementless implants. New Member Jamie Howard showed no difference in implant migration and kinematics of a single radius cementless design using either a measured resection or gap balancing technique and Dr Cushner show no difference in blood loss with cemented or cementless TKA with the use of TKA. The final two studies looked at staging and bilateral TKA's. Peter Sharkey showed that simultaneous TKA's were associated with higher complication compared to staged TKA and that staged TKA with less than a 90-day interval was not associated with higher risk. However, Mark Figgie showed that patients undergoing simultaneous TKA compared to staged TKA, missed 17 fewer days of work. In spite of the virtual nature of the meeting, there were some outstanding scientific interactions and the material presented will continue to generate debate and to guide the direction of knee arthroplasty as we move forwards


Bone & Joint Research
Vol. 13, Issue 4 | Pages 149 - 156
4 Apr 2024
Rajamäki A Lehtovirta L Niemeläinen M Reito A Parkkinen J Peräniemi S Vepsäläinen J Eskelinen A

Aims

Metal particles detached from metal-on-metal hip prostheses (MoM-THA) have been shown to cause inflammation and destruction of tissues. To further explore this, we investigated the histopathology (aseptic lymphocyte-dominated vasculitis-associated lesions (ALVAL) score) and metal concentrations of the periprosthetic tissues obtained from patients who underwent revision knee arthroplasty. We also aimed to investigate whether accumulated metal debris was associated with ALVAL-type reactions in the synovium.

Methods

Periprosthetic metal concentrations in the synovia and histopathological samples were analyzed from 230 patients from our institution from October 2016 to December 2019. An ordinal regression model was calculated to investigate the effect of the accumulated metals on the histopathological reaction of the synovia.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 5 | Pages 599 - 603
1 May 2007
Robertsson O Stefánsdòttir A Lidgren L Ranstam J

Patients with osteoarthritis undergoing knee replacement have been reported to have an overall reduced mortality compared with that of the general population. This has been attributed to the selection of healthier patients for surgery. However, previous studies have had a maximum follow-up time of ten years. We have used information from the Swedish Knee Arthroplasty Register to study the mortality of a large national series of patients with total knee replacement for up to 28 years after surgery and compared their mortality with that of the normal population. In addition, for a subgroup of patients operated on between 1980 and 2002 we analysed their registered causes of death to determine if they differed from those expected.

We found a reduced overall mortality during the first 12 post-operative years after which it increased and became significantly higher than that of the general population. Age-specific analysis indicated an inverse correlation between age and mortality, where the younger the patients were, the higher their mortality. The shift at 12 years was caused by a relative over-representation of younger patients with a longer follow-up. Analysis of specific causes of death showed a higher mortality for cardiovascular, gastrointestinal and urogenital diseases. The observation that early onset of osteoarthritis of the knee which has been treated by total knee replacement is linked to an increased mortality should be a reason for increased general awareness of health problems in these patients.