Aims. Metal allergy in knee arthroplasty patients is a controversial topic. We aimed to conduct a scoping review to clarify the management of metal allergy in primary and revision total knee arthroplasty (TKA). Methods. Studies were identified by searching electronic databases: Cochrane Central Register of Controlled Trials, Ovid MEDLINE, and Embase, from their inception to November 2020, for studies evaluating TKA patients with metal hypersensitivity/allergy. All studies reporting on diagnosing or managing metal hypersensitivity in TKA were included. Data were extracted and summarized based on study design, study population, interventions and outcomes. A practical guide is then formulated based on the available evidence. Results. We included 38 heterogeneous studies (two randomized controlled trials, six comparative studies, 19 case series, and 11 case reports). The evidence indicates that metal hypersensitivity is a rare complication with some histopathological features leading to pain and dissatisfaction with no reliable screening tests preoperatively. Hypoallergenic implants are viable alternatives for patients with self-reported/confirmed metal hypersensitivity if declared preoperatively; however, concerns remain over their long-term outcomes with ceramic implants outperforming titanium nitride-coated implants and informed consent is paramount. For patients presenting with painful TKA, metal hypersensitivity is a diagnosis of exclusion where patch skin testing, lymphocyte transformation test, and synovial biopsies are useful adjuncts before revision surgery is undertaken to hypoallergenic implants with shared decision-making and informed consent. Conclusion. Using the limited available evidence in the literature, we provide a practical approach to metal hypersensitivity in TKA patients. Future national/registry-based studies are needed to identify the scale of metal hypersensitivity, agreed diagnostic criteria, and management strategies. Cite this article: Bone Jt Open 2021;2(10):785–795

Background: Metal sensitivity following total joint arthroplasty (TJA) has been of increased concern, but the impact of a patient-reported metal allergy on clinical outcomes has not been investigated. The purpose of this study was to report the incidence and impact of patient-reported metal allergy following total knee (TKA) and total hip arthroplasty (THA). Methods: This was a retrospective, IRB-approved investigation of patients undergoing a primary, elective TJA between 2009 and 2011. All patients completed a pre-operative questionnaire asking about drug and environmental allergies. In January of 2010, a specific question was added regarding the presence of a metal allergy. UCLA Activity, SF-12, Modified Harris Hip (MHHS), and Knee Society (KSS) scores were collected pre-operatively and at most recent follow-up. Overall cohorts of metal allergy and non-metal allergy patients were compared and a 1:2 matching analysis was also performed. Results: 906 primary THAs and 589 primary TKAs were included. The incidence of patient-reported metal allergy was 1.7% before January 2010 and 4.0% after (overall 2.3% of THAs and 4.1% of TKAs). 97.8% of metal allergy patients were female. Following TKA, post-operative KSS function, symptoms, satisfaction, and expectation scores were all decreased in the metal allergy cohort (p<0.001 to 0.002). Following THA, metal allergy patients had a decreased post-operative SF-12 MCS score and less incremental improvement in their SF-12 MCS score versus the non-metal allergy cohort (p<0.0001 and p<0.001). Conclusion: Patient-reported metal allergy is associated with decreased functional outcomes following TKA and decreased mental health scores following THA

Introduction. 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. Methods. 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. Results. 36 of the 194 patients had a previously well functioning implanted metal device. In addition, data was missing in 19 patients. Therefore, data from 139 out of 158 consecutive patients who had no prior implanted metal devices was available. 20 of 139 patients (14%) reported a known metal allergy or sensitivity. This included 19 of 86 females (22%) and 1 of 53 males (2%). This difference was statistically significant (P=0.001). Conclusions. If self reported prior metal sensitivity or allergy is used to guide prosthesis selection in TKA, approximately 14% of patients would be candidates for “hypo-allergenic” prostheses. If only particular sizes of components are offered in these alternative materials, smaller sizes or female gender specific sizes should be considered due to the higher incidence of self reported metal allergies in female patients

It is estimated that 15 % of the population is allergic to metal, most commonly to Nickel, which is a common component of the alloys in most knee and hip arthroplasties. It would therefore be expected that allergy to metal is a frequent form of implant failure – but very little is reported in the literature. With the recent concerns about metal-on-metal bearings and metal ion issues, there has been renewed interest in metal allergy – with the Australian Joint Registry 2010 reporting it as a causative factor in 7 % of Hip Resurfacing revisions. With over 200 BHR and 571 ASR Hip Resurfacing arthroplasties in my series from 2001, I have identified only 1 patient with implant failure due to metal allergy. In 2010 two Total Knee Arthroplasty patients presented with pain and strongly positive Melisa allergy tests – these patients were revised to Titanium coated implants resulting in a complete relief of symptoms. This paper will analyse the problem of metal sensitivity, the investigation and management of the allergic patient who has, or requires, joint arthroplasty

Summary Statement. Routine metal allergy screening prior to joint arthroplasty is not essential and the use of cobalt chromium or stainless steel implants is recommended regardless of the patient's metal allergy status. Introduction. This study was undertaken to obtain a consensus amongst joint arthroplasty experts with regards to metal allergy screening prior to joint arthroplasty and the choice of implant in patients with potential metal allergy. Patients & Methods. A web based Delphi consensus study was used including orthopaedic surgeons that had previously published on the topic of knee, hip or shoulder arthroplasty. Two rounds of questionnaires were sent via electronic mail. Consensus was considered if agreement was 60% or higher. Results. 18 surgeons responded to the first and 17 to the second round of questionnaires. There was consensus that patients having metal arthroplasty surgery should not be routinely questioned about metal allergy prior to surgery. There was consensus that patch testing is not necessary even if metal allergy is suspected. Most respondents agreed in proceeding with cobalt chromium or stainless steel implant in patients suspected of metal allergy regardless of the results of cutaneous patch testing. Discussion/Conclusion. This consensus study suggests that routine metal allergy screening prior to joint arthroplasty is not essential. The use of traditional cobalt chromium/stainless steel implants is recommended regardless of the patient's metal allergy status

Introduction. There has been much controversy around metal on metal hip replacements of late due to adverse metal reactions. There is evidence implicating lymphocyte mediated response (type IV delayed-hypersensitivity) to metal debris generated by the implants as one of the main factors responsible for the reactions. Our understanding of these adverse reactions continues to improve but we also recognize that the majority of patients with MOM implants are asymptomatic with well functioning implants. Studies have shown up to 16% allergy to metal ions on pre-operative allergy patch testing. We set out to determine the incidence of hypersensitivity to Cobalt, Chromium and Molybdenum in a arthroplasty population. Method. We assayed whole blood using a validated optimized lymphocyte transformation test, MELISA as part of a prospective randomized study on large diameter bearing surfaces. We recruited 47 subjects, 19 males, 28 females (35–75 yrs). Specific exclusions included presence of metal implants in the body and industrial exposure to metals. Results. Results were available for 46 patients. Four patients (9%) demonstrated hypersensitivity to Cobalt and none to Chromium or Molybdenum. Two were female and two male. The result was weakly positive in three patients and strongly positive in one female. Conclusion. Hypersensitivity in patients without prior exposure to Cobalt, Chromium and Molybdenum is low. The relevance of a positive hypersensitivity test and implications on the choice of bearings is a subject that requires further research. NO DISCLOSURES

In a randomized study of 60 patients allergic reactions are evaluated in three joint prosthesis groups, a resurfacing arthroplasty (ReCap), a non-cemented, large metal-on-metal head (Bimetric Magnum) and a non-cemented, alumina ceramic-on-ceramic bearing in a titanium shell (Bimetric C2a).

The inclusion criteria were osteoarthritis, ASA I–II, MRI-scan without caput necrosis, DXA-scan without osteoporosis. The exclusion criteria were short neck (<2cm.), large cysts (>1cm.), medical treatment affecting the bone metabolism, severe deformity of the femoral head, impaired kidney function and inability to co-operate.

Blood samples were drawn prior to and 6 weeks, 6 months, 1 year, and 3 years after surgery; two tubes from which plasma was prepared, and two tubes for serum. From the last included 20 patients in each group was also taken blood one and three years after surgery for an in vitro lymphocyte assay for scoring of possible hypersensitivity to prosthesis metals. The isolated lymphocytes were subjected to measurement of proliferation and expression of CD69 by flow cytometry and measurement of the Migration Inhibitory Factor (MIF) by ELISA. Plasma concentrations of the cytokines IL-1, IL-4, IL-6, IL-8, IL-12p70, IL-15, interferon-and osteoprotegerin were determined by multiplex-immunoassay. Serum concentrations of chromium and cobalt were determined by graphite furnace atomic absorption spectrometry.

The serum concentrations of chromium and cobalt were lowest in patients with the C2a implant and highest with Magnum, some of these differences were significant at 6 weeks, 6 months, and 1 year after surgery. No patient had a very high serum metal concentration. The values of the variables measured in the in vitro lymphocyte assay mainly changed in the expected direction depending on the concentration of the same metal in the serum sample drawn at the same time, but no significant correlation was seen. One patient had uncertain symptoms of metal hypersensitivity and relatively high serum metal concentrations 3 years after arthroplasty with a Magnum prosthesis and was assessed extraordinarily, and elicited the marginally highest MIF responses in the lymphocyte assay. A strong correlation was found between the plasma concentrations of most cytokines, but the cytokine concentrations were not correlated to contemporary metal concentrations.

Abstract. Introduction. The aims of our systematic review were to assess the Nickel sensitising potential of total knee arthroplasty (TKA), explore the relationship between Nickel hypersensitivity and clinical outcomes, and evaluate the utility of skin patch testing pre- and/or post-operatively. Methodology. A literature search was performed through EMBASE, Medline and PubMed databases. Articles were screened independently by two investigators. Levels of Evidence were assessed using Oxford CEBM criteria and quality was assessed using MINORS and Cochrane risk-of-bias tools. Results. Twenty studies met the eligibility criteria, reporting on 1354 TKAs. Prevalence of Nickel hypersensitivity ranged from 0% to 87.5%. Only one study which compared prevalence of hypersensitivity in the same patient group before and after surgery noted newly positive patch test reactions in 4.1%. Three studies reported lower prevalence of hypersensitivity in post-operative patients compared to pre-operative patients. Seven studies suggested hypersensitivity might cause complications; six studies did not support any relationship. Seven studies recommended pre-operative patch testing in patients with history of metal allergy; nine studies concluded testing may be valuable post-operatively. Conclusions. Patients undergoing TKA do not seem to be at increased risk of developing Nickel hypersensitivity, and there is conflicting evidence that patients with established hypersensitivity are more likely to experience adverse clinical outcomes. The evidence suggests performing patch testing pre-operatively in patients with history of metal allergy to aid selection of the most appropriate prosthesis, and post-operatively once common causes of implant failure have been excluded, since implant removal or revision with hypoallergenic implants may alleviate symptoms

Currently, there is considerable interest in the role that metal allergy may play in the clinical performance of orthopaedic devices. The extant literature suggests that metal allergy is a real clinical phenomenon, albeit the prevalence and clinical impact are not defined. Degradation products in the form of ionic or particulate debris can complex with local proteins and alter their conformation so that they may not be recognised as self-proteins. This can result in an adaptive immune response. The typical paradigm proposed for such an allergy is that of a delayed type hypersensitivity response (Type 4) whereby the antigenic stimulus interacts with antigen presenting cells and T lymphocytes to elicit a cell mediated immune response. There is some evidence that patients with metal-on-metal bearings and/or high serum metal levels elicit more response to metal antigen challenge measured as either patch test sensitivity or lymphocyte proliferation. Thus, while there is an idiosyncratic aspect of the allergic response, there is also a dose response component. The diagnosis of metal allergy remains a challenge as patch testing has not been shown to correlate well with clinical symptoms. In-vitro assays, such as lymphocyte transformation testing, have promise but await robust clinical validation before they can be considered reliable diagnostic testing modalities. Allergy to implanted metal orthopaedic devices is a rare clinical event, and is a diagnosis of exclusion. Revision surgery should be considered a last resort with the understanding that the outcomes are unpredictable. Given the limitations of current diagnostic modalities, widespread screening of patients for metal allergies prior to TKA is not recommended

The role of metal sensitivity or allergy in causing persistent symptoms or failure and need for a revision of a total joint replacement has been the topic of debate and controversy for decades. There was renewed interest in this area with the rise of metal-on-metal hip arthroplasty and the advent of adverse local tissue reactions. This led to an increase in metal ion testing as well as metal sensitivity testing. With the decline of the use of metal-on-metal hip components, this is now mostly an issue in knee arthroplasty. It is well known that a substantial percentage of patients have persistent symptoms following knee replacement. What remains in question is whether allergy to metal or other materials such as PMMA may be a contributing factor. It is accepted that the incidence of positive skin patch tests is higher in symptomatic failed joint replacements. Nickel sensitivity is most common as a positive skin test with up to 15% of patients demonstrating this followed by chromium and cobalt. A recent review by Lachiewicz et al. concluded that there was insufficient evidence to recommend routine or widespread cutaneous or in vitro hypersensitivity testing before primary TKA, that there is no evidence-based rationale to recommend a routine metal allergy screening questionnaire, that there is only anecdotal support for Ni-free implants, and that local dermatitis should be treated with topical steroids. In another article, routine screening for metal allergy was not recommended, however, selective screening for history of sensitivity or unexplained pain or early loosening was suggested. Other experts have recommended a role for utilizing a commercially available alternative to components containing nickel or cobalt in patients thought to be hypersensitive. A recent study, however, concluded that there was no difference in complications, revisions, or reoperations among patients who tested positive with patch testing whether they were treated with standard components or nickel free components. Likewise, a consensus panel published results from the United Kingdom in which cobalt chrome implants were recommended regardless of the patients metal allergy status. Patient perception is important, however, and among patients who report multiple allergies of any kind, a higher percentage are likely to be dissatisfied with their knee replacement. Of more importance are those reporting a specific allergy to metal are substantially more likely to express some dissatisfaction with their components. Metal allergy as a cause of chronic pain and/or early failure of joint replacement is rare if it exists at all. It is always a diagnosis of exclusion. Patients who think they are allergic are probably more likely to be more symptomatic following joint replacement. Whether or not to use a nickel free or hypoallergenic component in such patients remains an area of controversy

On hundred and ninety unselected patients, mean age 62(SD12.8) were operated upon by one surgeon, using same approach. HSS improved from 33 to 75 post-operatively, the low figures reflecting a high percentage of Charnley C patients (71%). There was a 5% mortality rate from unrelated causes. Early complications included a 2.97% femoral fracture rate within 4–8 weeks of surgery (analysis showed no relation between implant position, BMI, age or Charnley classification, but there was correlation between high level of satisfaction and early weight bearing). There was one infection and one dislocation. Late complications included 3 periprosthetic fractures, 3 dislocations and 2 aseptic cup failures. However, 30% of patients developed groin pain, increasing stiffness and clunking at 1–2 years following surgery. These patients were investigated with an ultrasound scan. 28 patients (14%) had an effusion and were aspirated. Chrome and cobalt levels in synovial fluid, blood and urine were very high. 13 patients have been revised. 1 showed infection, 10 showed metal allergy and 2 a mixed picture of allergy and foreign body reaction. In our MOM database (762 hips including the current study) a total of 35 patients were revised for similar problems. Two distinct histological finding were observed. Metal allergy occurred independently of cup angle. The implants were well fixed; there was tissue necrosis and histological evidence of ALVAL. There was no infection or metalosis. FB reaction occurred more frequently when the cup was open. The Implants were loose; there was naked eye evidence of metalosis and metallic particles seen on light microscopy. We concluded that Birmingham/Freeman Hybrid had high complication rate without significant functional superiority, and other MoM devises shared similar complication. Both Metal allergy and FB reaction can occur in MOM THR. Ultra sound is a good screening tool in symptomatic patients

Metal-on-metal bearings have become popular in the last ten years because of a low wear rate combined with the ability to use large head sizes for conventional total hip arthroplasty (THA) and to facilitate resurfacing hip arthroplasty. Further advantages of metal-metal bearings include the fact that they are not at risk for fracture, and they can be made as modular or non-modular acetabular implants. It was recognized early that metal-on-metal implants had the potential to increase serum ion levels, and this was demonstrated in a number of studies. The significance of elevated ion levels, however, for most patients has been primarily a theoretical concern of toxicity, carcinogenesis or mutagenicity, and to date very few, if any, systemic problems related to systemic metal ions have been documented with certainty. Nevertheless, most surgeons have avoided use of the implants in patients who are likely to become pregnant, patients with renal disease, or patients with major systemic illnesses which have a high likelihood of leading to renal disease. Furthermore, most have avoided using them in patients with known dermal metal allergies, even though the connection between dermal metal allergies and metal bearings has not been established. Unexpectedly, an extremely important concern has emerged with metal bearings: the finding of local inflammatory reactions related to metal bearings. These inflammatory reactions can take several forms including pain with a milky effusion, local tissue necrosis, or large fluid collections or pseudotumors. The histology of these different reactions appears to be predominantly lymphocytic in nature and a term for at least some of these reactions has been coined “AVALS”. Whether these local reactions are primarily immunologic in nature or primarily related to dose of local metal ions or debris remains uncertain. While there is much still to be learned, it appears that certain patient populations may be at increased risk for metal reactions, possibly related to implant size (women and smaller patients). It also seems verticallyoriented implants, which create edge loading, increase wear and increase risk of local metal reactions. Perhaps the most important question is the incidence of local metal reactions, which remains to be defined. To date the problems in most series have been infrequent, less than 1 or 2 percent. However, in a few selected series the incidence has been higher, and when screening has been done for asymptomatic patients with fluid or masses around the joint, the rate has been higher in at least one reported series. Surgeons may interpret the importance of local metal reactions differently, but certainly ultimately incidence of this problem will have a very major effect on the future of these bearings

Introduction. The utilization of lymphocyte transformation testing (LTT) has increased for diagnosing metal sensitivity associated with TKA, but its validity for the diagnosis of TKA failure due to an immune reaction has not been established. Methods. We performed a retrospective study of 27 well-fixed, aseptic primary TKAs with persistent pain and/or stiffness, revised by a single, experienced surgeon for suspected metal allergy to nickel based on a positive LTT. Periprosthetic tissue samples obtained at the time of revision surgery were scored using the aseptic lymphocytic vasculitis-associated lesion (ALVAL) scoring system. Results. Eight patients were categorized as mildly reactive, 8 reactive, and 11 highly reactive to nickel by LTT. The predominant findings on routine histology were fibrosis and varying degrees of lymphocytic infiltration in 17/27 (63%) of the cases. The average ALVAL score of the cohort was 3.1 ± 1.9, out of a maximum score of 10. Average Knee Society Scores (KSS) improved post-revision, as did range of motion (all p<0.01). Neither LTT stimulation index as a continuous variable nor as a categorical variable (mild, moderate, high) was correlated with ALVAL score, pre-operative function, or change in function at last follow-up (0.015 < r < 0.30, 0.13 < p < 0.95) as measured by KSS. In addition, the ALVAL score did not correlate significantly with either pre-operative or post-operative KSS or range of motion (0.061 < r < 0.365, 0.09 < p < 0.88). Conclusions. Based on this analysis including histopathology, LTT results alone are insufficient for the diagnosis of TKA failure due to an immune reaction. A positive LTT may not indicate that an immune reaction is the cause of pain and stiffness post-TKA. The role of LTT in assessing immune failure of TKA needs further investigation. Diagnostic criteria for immune failure of a TKA need to be established

Introduction. Today TKR is considered one of the most successful operative procedures in orthopedic surgery. Nevertheless, failure rates of 2 – 10% depending on the length of the study and the design are still reported. This provides evidence for further development in knee arthroplasty. Particularly the oxide ceramics used now in THA show major advantages due to their excellent tribological properties, their significantly reduced third-body wear as well as their high corrosion resistance. A further advantage of ceramic materials is their potential use in patients with metal allergy. Metallic wear induces immunological reactions resulting in hypersensitivity, pain, osteolysis and implant loosening. The purpose of our study was to examine the safety of the tibial component of a novel all-ceramic TKR. Materials and Methods. We tested the tibial components of the primary knee implant BPK-S Integration Ceramic. Both the tibial and the femoral component consist of BIOLOX®delta ceramic The standards ISO 14879-1 and ASTM F1800-07 describe the test set-up for the experimental fatigue strength testing of tibial components from knee implants. We conducted the testing with a significantly increased maximum load of 5,300 N (900 N are required). A final burst strength test was carried out after the fatigue load testing in the same embedding and with the same test set-up. Results. No specimen failed during fatigue load testing. The subsequent post-fatigue burst strength testing showed a maximum strength against fracture of at least 9.7 kN for size 3 and at least 12.1 kN for size 6. Discussion. The good results of the strength testing of the tibial component of the BPK-S Integration Ceramic tibial plateau supported the good initial clinical outcome without any implant specific complications of this knee design. Further clinical studies have to show if this design fulfills the high expectations over long periods of time

Stiffness remains one of the most common, and challenging postoperative complications after TKA. Preoperative motion and diagnosis can influence postoperative motion, and careful patient counseling about expectations is important. Postoperative stiffness should be evaluated by ruling out infections, metal allergy, or too aggressive physical therapy. A careful physical and radiographic examination is required. Manipulation under anesthesia (MUA) in selected cases can be helpful. The best timing to perform MUA is between the 6th and 10th week postoperatively. Careful technique is required to minimise the risk of fracture or soft tissue injury. This requires complete paralysis! For more chronic stiffness, revision may be indicated if an etiology can be identified. An excessively thick patellar resurfacing, an overstuffed tibia insert, an oversized femoral component, or gross malrotation should be corrected. During revision, thorough synovectomy, release of contractures, ligamentous balancing and restoration of the joint line is required. Careful attention to component rotation, and sizing is critical. Downsizing components is helpful to place less volume into the joint space. Patients should be counseled that the results of revision for stiffness are mixed and somewhat unpredictable. More frequent postoperative nurturing is helpful to guide rehabilitation progress. Manipulation after revision at 6 weeks is almost expected

Purpose of the study. We reviewed one hundred and twenty patients who had primary total hip replacement using Corail/Pinnacle Metal on metal bearing surfaces between 2006 and 2009. We were interested in the metal ion levels of the whole cohort, the incidence of unexplained pain, pseudo tumour lesions (ALVAL) and early loosening and failure. We were particularly interested in the relationship of the acetabular cup position in relation to the pelvis and lumbar spine. Material and methods. We reviewed 120 charts and 104 patients in total. All patients had metal ion assays (cobalt and chromium). All patients had standardised radiographic evaluation using a special technique to assess acetabular cup position and the relationship to the pelvis and lumbar spine. Results. Ten patients had mild hip pain. This was not considered to be pathological pain related to the MOM articulation. None of the patients had any generalised symptoms of metal allergy as reported in the literature. We detected one patient with soft tissue fluid collections suggestive of an ALVAL lesion on ultrasound. The average cup inclination was 48 degrees with a range from 34 to 53 degrees. Conclusion. Our experience at 5 years with the Corail/Pinnacle Metal on Metal articulation has been acceptable. NO DISCLOSURES

Implant related hypersensitivity is an infrequent complication after total knee replacement. It remains a relatively unpredictable and poorly understood cause of failure of an implant. We present a report of five patients who presented with persistent hypertrophic synovitis after total knee replacement using a cobalt chrome component. Extensive preoperative and intraoperative attempts ruled out infection as a cause of symptoms. The knees had good ligamentous balance and were well aligned and fixed. The clinical condition improved after revision to a zirconium femoral and titanium metal backed tibial components. Intraoperative histopathology revealed thickened synovium with a predominantly monocellular (lymphocytic or histiocytic) response. Where infection has been excluded as a cause of persistent pain and swelling, consideration should be given to metal allergy as a cause of failure in primary knee replacement surgery

Background. Implants based on the polyetheretherketon (PEEK) polymer have been developed in the last decade as an alternative to conventional metallic devices. PEEK devices may provide several advantages over the use of conventional orthopedic materials, including the lack of metal allergies, radiolucency, low artifacts on magnetic resonance imaging scans and the possibility of tailoring mechanical properties. The purpose of this study was to evaluate the clinical results at mean 24-month follow-up using a new plate made of carbon-fiber-reinforced polyetheretherketon (CFR-PEEK) for the treatment of distal radius fractures. Materials and methods. We performed a prospective study including all patients who were treated for unstable distal radius fracture with a CFR-PEEK volar fixed angle plate. We included 70 consecutive fractures of AO types B and C that remained displaced after an initial attempt at reduction. The fractures were classified according to the AO classification: 35 fractures were type C1, 13 were type C2, 6 were type C3, 5 were type B1 and 11 were type B2. Results. All fractures healed, and radiographic union was observed at an average of 6 weeks. The final Disabilities of Arm, Shoulder and Hand score was 5.2 points. The average grip strength, expressed as a percentage of the contralateral limb, was 94 %. Three cases of hardware breakage were reported. Two cases were due to intraoperative plate rupture caused by the attempt to achieve the reduction of the fracture in 1 case and while inserting a distal screw in the other case. In the last case hardware breakage was caused by a fall on the injuried arm 1 week after surgery. No cases of loss of the surgically achieved fracture reduction were documented. Hardware removal was performed in 3 cases, for the occurrence of extensor tenosynovitis in 2 patients and tenosynovitis of flexor pollicis longus in 1 case. Conclusion. The major advantage of CFR-PEEK plate is its radiolucency. This characteristic allows direct visualization of osseous callus formation, allowing monitoring of the healing of the fracture, thereby improving clinical assessment and accuracy. Therefore, specific indications for this new radiolucent plate can be represented by fractures with significant metaphyseal comminution and in cases of nascent malunion where a distal radius osteotomy with bone grafting is usually performed to correct the wrong angle. At early follow-up this device showed good clinical results and allowed maintenance of reduction in complex, AO fractures. The occurrence of tendon complications related to this implant was similar to that reported in literature for the other new-generation plates. However, attention should be payed when stressing the plate to achieve the desired fracture reduction to avoid hardware failure

Purpose. Aim of the study was to assess difficulties and adverse effects in more than 400 CAS hip replacements using a short modular femoral stem to assess their incidence and to determine if this surgical procedure has to be considered as an high demanding surgical technique. Materials and Methods. Since 1998, 511 computer assisted hip replacements using a short modular stem were performed in our department. 403 implants were followed for at least 6 months postoperatively and included in the study. All the cases were divided into 3 series according to when the surgery had been performed to consider the evolution of the navigation systems and the surgeons familiarity with this improvement (group A: 1998–2003, group B: 2004–2008 and group C: 2009–2014). All intra-operative problems (difficulties that required no operative intervention to resolve or without any conseguence on the navigation process), intra-operative obstacles (difficulties that required operative intervention or that caused a failure of the navigation process) and complications (intra-operative injuries and all the problems following in the first 6 months post-operatively) were registered. Adverse facts not directly caused by the surgical but derived by other conditions were excluded from the study. Results. There were no differences in number of total problems/complications among the 3 groups. Obstacles were statistically higher in group A where we observed a higher incidence of navigation failures in association both to the first software versions and to a minor surgical experience. We did not register any statistically significant difference in the number of septic THR (complication) and incidence of superficial pin site infections (complication). One case in group A had to be successfully revised because a proven metal allergy in group B. We registered 8 cases of proximal femur fractures with different distribution among the 3 groups. In 1 case in group A we experienced an acetabular fracture during cup impaction managed with rest. No abnormal intra operative or post operative bleeding was registered because of the surgical technique with no statistical difference in clinical evident DVT among the 3 groups. Surgical time was longer in group A with a statistical significant difference in group A compared both to group B and C. Conclusion. In this study the authors registered both a higher rate in navigation failure and longer surgical time in the first cases even because of less advance navigation systems and lower experience with CAS. However in a series of more than 400 CAS THRs using a modular short femoral stem the authors could demonstrate no increased rate of complications compared to traditional techniques

Introduction. The purpose of this study was to introduce our perioperative prophylaxis method for infection and clarify surgical site infection rate in our patients performed total hip arthroplasty (THA). Method. Two hundred and eighty four THA (including revision 18 cases) performed by single surgeon between Oct. 2007 and Jan. 2013 were evaluated. The mean age of patients was 65.7 years old. The male to female ratio was 46 to 238. BMI was 23.6. Ninety patients (32%) were compromised host suffering from diabetes mellitus, rheumatoid arthritis, autoimmune disease, history of malignant tumor, hemodialysis or skin disease at surgical site respectively. At preoperative period, we checked decayed tooth, alveolar pyorrhea, hemorrhoids, and leg skin condition. In addition, we examined culture of nasal cavity. At the day of surgery, patient took a shower just before entering surgical room. All of THA was performed in clean room NASA class 100. Surgeons and assistant nurse put on nonwoven fabric gown, space suit and double rubber gloves. We wiped surgical site leg by gauze impregnated by 0.5% chlorhexidine alchohol to eliminate skin bacteria twice just before surgeons scrubbing hands. Surgical site was covered by povidone iodine containing drape. Surgeons or nurse changed gloves when glove was broken at each time. We cleaned surgical field by pulse washer whenever necessary. We did not use drain except for 5 revision THAs. Regarding to prophylactic antibiotics usage, we administered cefcapene pivoxil orally the day before surgery. Drip infusion antibiotics (PIPC: until Oct. 2008, CEZ: after Oct. 2008) was administered at the period of 30 min. before surgery and 4 hours after surgery in case of prolonged surgical time (4 hours >). Skin closure was performed by staple and covered by gauze until May 2010. After that, we used surgical tape and transparent water proof sheet. After finishing surgery, antibiotic was administered 8 hours interval at surgery day and 12 hours interval for additional two days. In case multi-drug resistant bacteria (MRSA, MRSE) was positive in nasal culture, we applied mupirocin ointment to nasal cavity for 3 days before surgery and administered vancomycin (from Aug. 2011) or linezolid (from 2012) for prophylactic antibiotics in perioperative period. Results. Multi-drug resistant bacteria was detected from nasal cavity in 23 patients (8%). The mean operation time was 194 min (due to education for young surgeon). Intraoperative bleeding was 598g. Length of skin incision was 13.6 cm. Intraoperative wash volume was 4500 ml. The infection rate were 0 % in early period and 0.7 % (two case) in late period respectively. One infected case was 75 years old female. Deep infection was occurred 3 years after surgery. She was administered steroid and immunosuppressive drug due to metal allergy after total knee arthroplasty. The other case was 64 years old female. Superficial infection happened 3 months after THA. The patient was suffered from collagen disease and diabetes. Conclusion. Our prophylaxis method for surgical site infection of THA achieved 0 % in early infection and 0.7% late chronic infection respectively