Metal hypersensitivity in trapeziometacarpal arthroplasty: A systematic pattern of progression.

Metal hypersensitivity is a rare and often underestimated complication, as shown by the small number of published studies, particularly concerning the upper limbs and the hand. However, the increase in the annual number of trapeziometacarpal arthroplasties underlines the importance of better understanding of this problem. We performed a study based on data from the revision of trapeziometacarpal prostheses to assess the incidence of this complication and to define a sequence of radiological changes to detect metal hypersensitivity. This single-center retrospective study included 37 patients operated on between January 2014 and November 2023 for revision of trapeziometacarpal prosthesis. Ten (27%) had no clearly identified cause of failure. For these 10 patients, we analyzed clinical data and postoperative X-rays. In the 11 revision arthroplasties, 2 patients had no symptoms or radiographic signs suggestive of allergy. Six patients had a-posteriori diagnosis established by allergy testing, which also identified 2 additional patients, for a total of 8 patients (21% of the initial cohort). In these cases, there was systematic metaphyseal osteolysis of the first metacarpal between 15 days and 1 month after implantation. Clinically, most patients had an asymptomatic period of 2 weeks to 1 month before onset of symptoms and osteolysis, often accompanied by local inflammation. This study found a reproducible pattern of progression, characterized by the appearance of radiographic signs of osteolysis in the first month, followed by clinical deterioration. Although this course is strongly suggestive of a metal hypersensitivity, it is crucial not to exclude the possibility of an infectious cause, which should always be considered.

The impact of allergies on patient-reported outcomes after total hip and knee arthroplasty: a systematic review and meta-analysis.

INTRODUCTION: Metal hypersensitivity has been associated with persistent symptoms after total hip arthroplasty (THA) and total knee arthroplasty (TKA), despite successful joint replacement. Allergies frequently co-occur and have been linked to psychiatric disturbances such as anxiety. There is a knowledge gap regarding the effect of allergies, including metal hypersensitivity, on patient-reported outcome measures (PROMs) after THA and TKA. This study aimed to evaluate the influence of allergies including metal hypersensitivity on PROMs in patients undergoing THA and TKA. MATERIAL AND METHODS: A systematic search PROSPERO (CRD42023475972) was conducted using PubMed, EMBASE, Scopus, and Cochrane databases. Studies that compared allergic and non-allergic adults undergoing primary THA or TKA and reported PROMs were included. Methodological quality was assessed using the MINORS criteria. The mean differences (MD) and standardized mean differences (SMD) with 95% confidence intervals (CI) were calculated. Eight studies, involving 33,808 patients, were included. RESULTS: For functional outcomes assessed using SF-12, SF-36, KOOS JR, and HOOS JR, allergic patients demonstrated significantly worse scores (SMD - 0.23, 95% CI -0.36 to -0.09). The WOMAC functional scale also demonstrated poorer results in allergic patients (MD 2.49, 95% CI 0.64 4.35). For pain assessed using the WOMAC pain scale, allergic patients reported significantly greater pain (MD 1.04, 95% CI 0.46 1.62). Changes in mental status assessed using the SF-12 and SF-36 did not show significant differences between the groups (MD -0.46, 95% CI -1.40 to 0.47). In subgroup analysis, patients in the THA subgroup showed significantly worse outcomes (MD -7.20, 95% CI -12.97 - -1.43). CONCLUSION: This meta-analysis found that patients with allergies, including metal hypersensitivity, generally had worse functional outcomes after THA and TKA than patients without allergies. Further research is required to confirm these findings. Preoperative allergy screening can identify individuals at risk of treatment optimization.

Hypersensitivity to metals in metal-on-metal hip arthroplasty: a prospective study of one hundred and thirty five lymphocyte transformation tests.

BACKGROUND: Metal allergy remains a controversial topic in the orthopaedic community. It is not known if or to what degree metal sensitivity contributes to inflammatory soft tissue failures, unexplained residual pain, or clinical complications after total joint replacement with metal prostheses. METHODS: We investigated the efficacy of the lymphocyte transformation test (LTT) in predicting adverse outcomes in patients after receiving a metal joint replacement. Our study cohort consists of 135 metal-on-metal hip resurfacing arthroplasty cases performed between 2013 and 2015. All study patients had an LTT preoperatively. We retrospectively analyzed clinical outcomes and failures for our cohort. RESULTS: There was no difference in LTT reactivity between men and women. Of the 135 patients tested, 46 (34.1% of cohort) tested positive to at least one of the materials comprising their implant, and 78 patients (57.8%) had at least one reactive score to any component of the LTT. After a minimum follow-up of two years, we did not observe an allergic response to the implant in any patients. There were no failures requiring revision. We observed a 2.2% rate of moderate residual pain; no patients with residual pain tested positive for metal sensitivity. When patients with moderate-high LTT reactivity (30.4% of cohort) were compared to the remainder of the study group, there was no difference in HHS or UCLA activity score. There was no correlation between blood metal ion levels and LTT reactivity. CONCLUSION: We were unable to prove any predictive value of the LTT. We failed to identify hypersensitivity to metals in patients with metal-on-metal hip resurfacing arthroplasty.

Do Patients With Hypoallergenic Total Knee Arthroplasty Implants for Metal Allergy Do Worse? An Analysis of Health Care Utilizations and Patient-Reported Outcome Measures.

BACKGROUND: Metal allergy is a rare and controversial cause of implant failure and poor outcomes following total knee arthroplasty (TKA). Few studies have investigated clinical and patient-reported outcome measures (PROMs) in patients treated with hypoallergenic implants. This investigation aimed to compare: (1) health care utilizations (eg, hospital length of stay, 90-day readmission rate, and incidence of nonhome discharge) and (2) 1-year PROMs between patients who received hypoallergenic and standard TKA implants. METHODS: This was a retrospective review of prospectively collected data from patients who underwent primary TKA between 2018 and 2019. Propensity score matching (3:1) was used to compare standard TKA patients with those who received hypoallergenic TKA implants, respectively. Knee injury and Osteoarthritis Outcome Score (KOOS) pain, KOOS Physical function Shortform (PS), and Veterans RAND 12-Item Health Survey Mental Component Score were collected preoperatively and at 1-year. After matching, 190 hypoallergenic and 570 standard TKAs were analyzed. RESULTS: No differences were observed in length of stay (P = .98), 90-day readmission (P = .89), and nonhome discharge (P = .82). Additionally, there was no significant difference in change from preoperative to 1-year PROMs (KOOS pain, P = .97; KOOS PS, P = .88; Veterans RAND 12-Item Health Survey Mental Component Score, P = .28). Patient-reported satisfaction was similar at 1-year (P = .23). Patients achieved similar rates of Patient Acceptable Symptom State (PASS) and minimal clinically important difference (MCID) for KOOS pain (PASS, P = .77; MCID, P = .33) and KOOS PS (PASS, P = .44; MCID, P = .65). CONCLUSION: Patients treated with hypoallergenic TKA implants for suspected metal allergy had similar outcomes compared to patients who had standard implants and no metal allergy.

No difference in patient reported outcome and inflammatory response after coated and uncoated total knee arthroplasty - a randomized controlled study.

BACKGROUND: Allergies against implant materials are still not fully understood. Despite controversies about its relevance, some patients need treatment with hypoallergenic implants. This study compared coated and standard total knee arthroplasty (TKA) regarding inflammatory response and patient-reported outcome measures (PROMs). METHODS: 76 patients without self-reported allergies against implant materials were included in a RCT and received a coated or standard TKA of the same cemented posterior-stabilized knee system. 73 patients completed the 3-year follow-up. Two patients died and there was one revision surgery. Serum levels of cytokines with a possible role in implant allergy were measured in patient`s serum (IL-1beta, IL-5, IL-6, IL-8, IL-10, IFN γ, TNF α) prior to, one and three years after surgery. Furthermore, PROMs including knee function (Oxford Knee Score, Knee Society Score) and health-related quality of life (QoL, EuroQuol questionnaire) were assessed. Additionally, 8 patients with patch-test proven skin allergy against implant materials who received the coated implant were assessed similarly and compared to a matched-pair group receiving the same implant. RESULTS: There were no differences in function and QoL between the assessed groups at any follow-up. The majority of patients demonstrated no elevation of the measured blood cytokines. Cytokine patterns showed no differences between study groups at any follow-up. The allergy patients demonstrated slower functional improvement and minor differences in cytokine pattern. Yet these results were not significant. There were no differences in the matched-pair analysis. CONCLUSION: We observed no relevant increase in serum cytokine levels in any group. The inflammatory response measured seems limited, even in allergy patients. Furthermore, there were no differences between coated and standard TKA in non-allergy patients in the 3-year Follow-Up period. TRIAL REGISTRATION: The study protocol was registered in the US National Institutes of Health's database ( http://www. CLINICALTRIALS: gov ) registry under NCT03424174 on 03/17/2016.

Metal hypersensitivity in hip, knee and spine surgery.

The number of implanted joint prostheses and damaged spinal components is steadily increasing. At the same time, rejection of the implanted material is observed in operated patients, which manifests itself in both skin and general reactions, as well as loosening and earlier wear of implanted prostheses, which was previously referred to as aseptic reactions. However, it has been shown that in a significant proportion of patients, rejection of implanted material may be caused by hypersensitivity to a specific metal. For this reason, patients qualified for implantation of foreign material, mainly nickel, titanium, chromium, molybdenum, and other alloys, should be subjected to allergy tests to detect possible risks in the form of metal sensitivity reactions.

Patient Journey Map: Metal Hypersensitivity.

In this study, we highlight patients' experiences with metal hypersensitivity (MH) after receiving implantable medical devices (IMDs). We aim to identify gaps in clinical care and improve outcomes for individuals who have or may be sensitive to metals. Secondary data analysis from a previous interpretative phenomenological qualitative study was utilized. Using patient journey maps, we explored the experiences of 8 individuals from outpatient settings who received IMD and have first-hand experience with MH. We documented their journey from MH symptom recognition to diagnosis and subsequent IMD management. The results reveal that the time frames from device implantation to the treatment of MH varied from 17 to 228 months. The longest phase on the patient journey maps was the symptom recognition phase, which refers to the time between symptom emergence and MH diagnosis. Participants also required extensive healthcare utilization following their initial surgery. These findings emphasize that MH should be considered in differential diagnoses for patients with IMD. Early screening and detection of MH can enhance patient safety, alleviate distress, and reduce unnecessary healthcare utilization.

Hypersensitivity and lymphocyte activation after total hip arthroplasty.

In the last decades total hip arthroplasty (THA) has become a standard procedure with many benefits but also a few still unsolved complications, which can lead to surgical revision in 19-23% of cases. Thus, aseptic loosening and metal hypersensitivity remain challenges. The phenomenon of wear debris causes chronic inflammation, which produces osteolysis and aseptic loosening. Wear debris promotes osteoclast production and inhibits osteoblasts by secretion of pro-inflammatory cytokines. Micro-abrasions can be induced by abrasive, adhesive and fatigue wear and cause a liberation of metal ions, which lead to another immune response elicited mostly by macrophages. Another reaction in the neocapsule can be a type IV hypersensitivity reaction to various alloys, containing metals such as nickel, cobalt and chromium. Patch testing and the lymphocyte transformation test (LTT) are not the best diagnostic possibilities to exclude a postoperative hypersensitivity reaction, because of the different alignment of the epicutaneous cells compared to the periprosthetic deep tissue. This hypersensitivity reaction is mostly induced by cytokines, which are secreted by macrophages rather than lymphocytes. In cell cultures and in animal studies, multipotent mesenchymal stem cells (MSC) have been shown to play a role in improving initial implant integration, to limit periprosthetic osteolysis and also to reconstitute peri-implant bone stock during implant revision. Thus, MSC might be used in the future to prolong the durability of THA. A better understanding of the interactions between primary chronic inflammation, corrosion, osteolysis and hypersensitivity is mandatory to develop new therapeutic strategies, aiming at the reduction of the incidence of implant failures. In this article the underlying immunological mechanisms to aseptic loosening are presented.

Allergic reaction and metal hypersensitivity after shoulder joint replacement.

PURPOSE: Metal ion release may cause local and systemic effects and induce hypersensitivity reactions. The aim of our study is first to determine if implant-related hypersensitivity correlates to patient symptoms or not; second, to assess the rate of hypersensitivity and allergies in shoulder arthroplasty. METHODS: Forty patients with shoulder replacements performed between 2015 and 2017 were studied with minimum 2-year follow-up; no patient had prior metal implants. Each patient underwent radiographic and clinical evaluation using the Constant-Murley Score (CMS), 22 metal and cement haptens patch testing, serum and urine tests to evaluate 12 metals concentration, and a personal occupational medicine interview. RESULTS: At follow-up (average 45 ± 10.7 months), the mean CMS was 76 ± 15.9; no clinical complications or radiographic signs of loosening were detected; two nickel sulfate (5%), 1 benzoyl peroxide (2.5%) and 1 potassium dichromate (2.5%) positive findings were found, but all these patients were asymptomatic. There was an increase in serum aluminum, urinary aluminum and urinary chromium levels of 1.74, 3.40 and 1.83 times the baseline, respectively. No significant difference in metal ion concentrations were found when patients were stratified according to gender, date of surgery, type of surgery, and type of implant. CONCLUSIONS: Shoulder arthroplasty is a source of metal ion release and might act as a sensitizing exposure. However, patch test positivity does not seem to correlate to hypersensitivity cutaneous manifestations or poor clinical results. Laboratory data showed small constant ion release over time, regardless of gender, type of shoulder replacement and implant used. LEVELS OF EVIDENCE: Level II.

Similar clinical and radiographic outcomes after two different hypoallergenic medial unicompartmental knee in patients with metal allergy.

BACKGROUND: The purpose in the present study was to compare clinical and radiological outcomes of patients who had undergone a mobile-bearing unicompartmental knee arthroplasty (UKA) with either titanium niobium nitride (TiNbN) alloy implants or with fixed-bearing oxidized zirconium alloy implants. METHODS: The records of two consecutive cohorts for a total of 86 hypoallergenic implants were prospectively analyzed. The first cohort consisted of 49 consecutive implantations of the hypoallergenic UKA Journey Uni Oxinium (Ox Group), while the second consisted of 37 consecutive series of UKA Oxford (TiNbN Group). All patients were evaluated by two independent surgeons who were not involved in the index surgery. The clinical evaluation consisted of evaluating each patient's Oxford Knee Score and Knee Society Score day before surgery (T0), and with two consecutive follow-ups at T1 (minimum follow-up 9 months) and T2 (minimum follow-up 24 months). RESULTS: The two groups were homogeneous in all preoperative values, except Body Mass Index (BMI) and duration of final follow-up [both statistically higher (p < 0.05) in the TiNbN group]. Both groups showed a clinically significant improvement for all scores at final follow-up (p < 0.05). The only differences between the two groups involved a higher pre-operative Oxford Score in TiNbN group (p = 0.031), and different tibial and femoral angles at the final follow-up. CONCLUSIONS: Both TiNbN and Oxinium UKA procedures enabled patients from good to excellent clinical and radiographic outcomes after the final follow-up, regardless of the age, gender, BMI bearing type, and implant size. LEVEL OF EVIDENCE: LEVEL II: Comparative study.

Metal Allergy: State-of-the-Art Mechanisms, Biomarkers, Hypersensitivity to Implants.

Metal allergy is mainly an environmental disorder which can cause allergic contact dermatitis. Environmental metal exposures include jewelry, everyday metal items, mobile phones, leather, metal-rich food and implants, including stents or anchors. While consumer exposure is liable for the majority of metal hypersensitivity cases, the significance of occupational exposure to metals remains relevant. Although the most common metal allergens are nickel, chromium, and cobalt; however, lately, gold, palladium, titanium, and some others have also attracted attention. This review highlights advances in metal allergy mechanisms, biomarkers for potential patients' stratification as well as biological treatments. The most recent evidence of human exposure to metal for risk assessment is discussed, as well as the relationship between the occurrence of metal hypersensitivity and implanted devices, including non-characteristic symptoms. The latest data on the diagnosis of metal hypersensitivity are also reported.

Poor Correlation Among Metal Hypersensitivity Testing Modalities and Inferior Patient-Reported Outcomes After Primary and Revision Total Knee Arthroplasties.

Background: Metal allergy testing may influence clinical decision-making for patients undergoing a total knee arthroplasty (TKA). Limited data were found to examine the consistency of available testing modalities. This study compares different metal allergy test results and clinical outcomes after primary and revision TKAs in patients with and without metal hypersensitivity. Methods: Primary (n = 28) and revision (n = 20) TKA patients receiving hypoallergenic implants for metal allergies diagnosed by skin patch testing (SPT), lymphocyte proliferation testing (LPT), or lymphocyte transformation testing (LTT) were retrospectively reviewed. The agreement between tests was assessed by percentage and kappa statistic within patients who used multiple testing modalities. Postoperative clinical outcomes of these patients were compared to those of patients without metal hypersensitivity matched by age (±5 years), body mass index (±5), gender, and follow-up duration (±2 years). Results: SPT and LPT showed weak agreement for nickel and minimal agreement for cobalt. SPT and LTT showed minimal agreement for nickel; weak agreement for titanium, bone cement, vanadium, and zirconium; but strong agreement for chromium and cobalt. LPT and LTT agreement was weak. Compared to matched controls, metal hypersensitivity patients undergoing primary TKAs with hypoallergenic implants experienced less improvement in Knee Society Scores, Veterans RAND 12 physical component scores, and range of motion. Patients undergoing revision TKAs for multiple indications including metal hypersensitivity had worse clinical outcomes with significantly worse improvements in Knee Society functional scores compared to matched controls. Conclusions: Metal allergy tests produce conflicting results. Hypersensitivity patients may experience inferior clinical outcomes even with hypoallergenic implants. Clinician awareness may influence the choice of testing and improve preoperative counseling of this patient population.

Metal hypersensitivity and pro-inflammatory cytokine production in patients with failed orthopedic implants: A case-control study.

Orthopedic implants heal well without complications in most patients but fail for unclear reasons in some individuals. This study determined the relevance of metal hypersensitivity in patients with failed orthopedic implants and those requiring orthopedic implant surgery. The study included 35 patients with failed orthopedic implants and 15 subjects scheduled for orthopedic implant surgery. The production of selected pro-inflammatory cytokines was measured in patients with failed orthopedic implants. Metal hypersensitivity was measured in all subjects using the MELISA® test. Of common metals in orthopedic alloys, the patients with failed orthopedic implants responded most frequently to nickel, chromium, titanium, iron, and molybdenum. Hypersensitivity to metals found in implants was measured in 40% of patients with failed implants. The study also showed that titanium exposure in patients with titanium hypersensitivity might lead to implant failure. Metal hypersensitivity testing should be offered to patients before surgery to minimize the risk of implant failure.

Beneficial effect of a zirconium-nitride-coated implant in total knee arthroplasty revision for suspected metal hypersensitivity.

INTRODUCTION: Revision of total knee arthroplasty (rTKA) for suspicion of metal hypersensitivity (MHS) may require hypoallergenic implants. Results for coated implants have not been reported. The aim of the present study was to assess short-term results and survival of rTKA for MHS using a multilayer implant coating. HYPOTHESIS: Multilayer implant coating improves functional results in rTKA, with survival comparable to primary coated implants. MATERIAL AND METHODS: A single-center retrospective observational study included 28 patients (30 knees) undergoing rTKA for MHS using a coated implant between May 2011 and November 2016. Exclusion criteria comprised implant malpositioning and history of infection in the affected knee. Clinical and radiological results were assessed on the International Knee Society (IKS) and SF-36 functional scores and Ewald radiological score. Survival was calculated on Kaplan-Meier estimation. RESULTS: Mean follow-up was 3.8 years. Mean IKS score increased by 40.2 points (40%) [range, 28.1-52.3] (p<0.05). Mean range of motion increased by 17° [range, 9.5-24.5°] (p<0.05). Mean physical and mental SF-36 components were respectively 44.7 and 46.1. Survivorship was 93%. DISCUSSION: There was significant functional improvement after rTKA for MHS. There were no short-term complications related to the zirconium nitrate coating. However, studies with longer follow-up will be needed for confirmation. LEVEL OF EVIDENCE: IV; retrospective study.

Evaluation of local tissue peri-implant reaction in total knee arthroplasty failure cases.

Introduction: Implant-related hypersensitivity is emerging as a causative factor as a potential source of total knee arthroplasty (TKA) failure. Mechanistically, this type IV hypersensitivity reaction (T4HR) is mediated by effector T-cells, macrophages, and leukocytes that infiltrate to the site of implant and react to metal exposure and induce inflammatory tissue damage. Methods: A case-control study was performed where cortical bone was taken at the time of revision surgery for all patients operated on for primary TKA in which metal allergy was suspected and for revision TKA cases done for presumed metal allergy. Cytof was used to determine the cell density of inflammatory cells, specifically Th1, Th2, M1, and M2 cells. Results: Comparing the mean cell density of primary versus revision TKA, revision TKA patients had significantly higher number of Th2 cells compared with Th1 cells (p = 0.0043). Among revision cases, there were significantly more M1 versus M2 macrophages (p = 0.034) within a patient. When comparing mean cell density of M1 versus M2 macrophages, there was a significant difference in both primary and revision TKA surgeries (p = 0.0041 primary, p < 0.001 revision). Among revision patients who had a predominance of Th2 cells, four (44%) of nine patients had a negative LTT/patch test. Conclusion: These data support metal hypersensitivity, mediated by a T4HR, for some cases of TKA failure. Current methods to screen patients for metal hypersensitivity prior to primary TKA have been inclusive. This study demonstrates the need for a more sensitive screening test from specimens in the knee joint, to more accurately identify patients who will exhibit a T4HR to metal.

Lymphocyte Subset Ratio Cannot Diagnose Immune Failure of a TKA.

BACKGROUND: Up to 20% of patients are dissatisfied following total knee arthroplasty (TKA), most often due to pain and/or stiffness. The differential diagnosis includes immune reaction to the prosthesis. However, there is no consensus on diagnostic criteria for immune failure, an allergic reaction, to a TKA. Histologic evaluation could provide evidence as to whether an allergic reaction caused TKA failure. A recent study showed an increase in CD4+ lymphocytes compared to CD8+ lymphocytes in patients lymphocyte transformation testing (LTT) + for Ni. This finding is consistent with Ni sensitization, but can lymphocyte subsets be used to diagnose immune failure on a case-by-case basis? METHODS: Periprosthetic tissues from 18 revision cases of well-fixed, aseptic, but painful and/or stiff primary TKAs were analyzed. Six patients LTT- for Ni were matched as a cohort for age, sex, and body mass index (BMI), to 12 patients LTT + for Ni. Periprosthetic tissue biopsies underwent immunohistochemical IHC staining for CD4+ and CD8+ lymphocyte subsets and were compared by LTT status. The immunohistochemicalIHC results were also compared with periprosthetic histology. RESULTS: There was no relationship between LTT status and mean CD4+ cells/hpf or CD4+:CD8+ lymphocyte ratio. No relationship was found between LTT stimulation index (continuous or categorical) and CD4+:CD8+ ratio or aseptic lymphocyte-dominant vasculitis-associated lesion ALVAL score. CONCLUSION: Lymphocytes in periprosthetic tissue are highly variable in number, subtype ratio, and location, and have no relationship to LTT result or ALVAL score on a case-by-case basis. Based on these results, lymphocyte subsets cannot diagnose immune failure. Further work is needed to determine criteria for the diagnosis of immune failure of a TKA.

Similar rates of return to sports and BMI reduction regardless of age, gender and preoperative BMI as seen in matched cohort of hypoallergenic and standard Cobalt Chromium medial unicompartmental knee arthroplasty.

PURPOSE: To compare the rate of return to sports and body mass index (BMI) reduction in patients who underwent surgery for unicompartmental knee arthroplasty (UKA) with either Cobalt-Chromium (CoCr) alloy UKA or with hypoallergenic UKA, stratified by age, gender and BMI. METHODS: Two consecutive cohorts of patients with a total of 172 UKA and a minimum 2-year follow-up period were prospectively included in this comparative study. The first cohort consisted of 136 consecutive series of standard Cobalt-Chromium (CoCr Group). The second cohort consisted of 36 consecutive mobile-bearing hypoallergenic Titanium Niobium Nitride UKA, (TiNbN Group). The clinical evaluation was based on the University of California, Los Angeles (UCLA) activity scores and the High-Activity Arthroplasty Score (HAAS) evaluated on the day before surgery (T0) and after a minimum follow-up of 12 months (T1) and 24 months (T2). Radiographic evaluation performed at T2 included the femoral component position in varus/valgus, the tibial component in varus/valgus and the anteroposterior slope. RESULTS: No statistical differences were found between the groups at each follow-up, as shown by the UCLA and HAAS score (n.s.). Both groups showed a statistically significant improvement (p < 0.05) at each follow-up.. Both groups showed a statistically significant BMI reduction between T0 and T2 (p < 0.05). Radiographic analysis revealed no statistical differences between the two groups in terms of the three measures after the final follow-up (n.s.). All the subgroups showed a significant (p < 0.05) rate of return to sport if compared with the preoperative value (T2 versus T0), except for male in TiNbN group. CONCLUSIONS: Both TiNbN and CoCr medial mobile-bearing UKA enabled patients to return to sports after the final follow-up, regardless of age, BMI, gender and metal sensitivity. These findings inform shared decision making and can help to manage patient expectations after surgery, in particular, in active patients with an overt metal allergy, a specific hypoallergenic implant should be considered the gold standard implant in partial knee replacement surgery. LEVEL OF EVIDENCE: Cohort Study, Level III. REGISTRATION: researchregistry6250- www.researchregistry.com .

[The use of knee prostheses with a hypoallergenic coating is safe in the medium term : A randomized controlled study]. / Die Anwendung antiallergisch beschichteter Knieendoprothesen ist mittelfristig sicher : Eine randomisierte kontrollierte Studie.

BACKGROUND: In Germany, patients with contact allergy to implant components usually receive coated joint arthroplasties. Whether the treatment using these hypoallergenic implants achieves comparable results to standard treatment with implants consisting of cobalt-chromium alloy (CoCr) implants is controversially discussed internationally and has rarely been investigated in the mid-term. OBJECTIVES: Are there differences in blood metal ion concentrations, knee function, and patient-reported outcomes (PROM) between coated and standard implants? MATERIAL AND METHODS: 118 patients were randomized to receive either a coated or a standard implant. Knee function as well as patient-reported outcome measures were assessed. Metal ion concentrations in blood samples were additionally determined for chromium, cobalt, molybdenum, and nickel, preoperatively, one and five years after surgery. RESULTS: After five years, it was possible to analyse the results of 97 patients. In metal ion concentrations, as well as PRO, consistently good results were seen, without any difference between the groups. While in 13 patients there was an increase in chromium concentration above 2 µg/l one year after surgery, there was no measured value above 1 µg/l after five years. CONCLUSION: In our study, similar mid-term results were detected for coated (TiNiN) and standard (CoCr)TKA. With respect to metal ion concentrations and PRO there are no disadvantages in using coated TKA.