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

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

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

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