Best timing of bilateral total hip arthroplasty - an analysis of revision and mortality rates from the German Arthroplasty Registry (EPRD).

BACKGROUND: The burden of osteoarthritis (OA) in multiple joints is high and for patients with bilateral OA of the hip there is no clear recommendation about the indication for simultaneous (one-stage) bilateral total hip arthroplasty (THA) versus two-staged procedures. The purpose of this study was therefore to compare revision and mortality rates after different strategies of surgical timing in bilateral hip OA from the German Arthroplasty Registry (EPRD). METHODS: Since 2012 22,500 patients with bilateral THA (including 767 patients with one-staged bilateral surgery and 11,796 patients with another separate procedures within one year after first THA) are documented in the registry. The patients who underwent simultaneous bilateral THA were matched with a cohort of 767 patients who underwent the second THA between 1 and 90 days postoperatively (short interval) and another cohort of 4,602 patients with THA between 91 and 365 days postoperatively (intermediate interval). Revision for all reasons and mortality rates were recorded. Cox regression was performed to evaluate the influence of different patient characteristics. RESULTS: The cumulative 5-year revision rate for patients with simultaneous bilateral THA was 1.8% (95% CI 0.9-2.6), for patients with two-staged THA 2.3% (95% CI 1.0-3.6) in the short interval and 2.5% (95% CI 2.1-2.9) in the intermediate interval, respectively. In all three groups, patients who underwent THA in a high-volume center (≥ 500 THA per year) had a significant lower risk for revision (HR 0.687; 95% CI 0.501-0.942) compared to surgeries in a low-volume center (< 250 THA per year). There was no significant difference regarding cumulative mortality rates in the three cohorts. Higher age (HR 1.060; 95% CI 1.042-1.078) and severe comorbidities as reflected in the Elixhauser Score (HR 1.046; 95% CI 1.014-1.079) were associated with higher mortality rates after simultaneous THA. CONCLUSION: Simultaneous bilateral THA seems to be a safe procedure for younger patients with limited comorbidities who have bilateral end-stage hip OA, especially if performed in high-volume centers. LEVEL OF EVIDENCE: III.

Evaluation of a Digital Decision Aid for Knee Replacement Surgery.

BACKGROUND: We studied whether an individualized digital decision aid can improve decision-making quality for or against knee arthroplasty. METHODS: An app-based decision aid (EKIT tool) was developed and studied in a stepped-wedge, cluster-randomized trial. Consecutive patients with knee osteoarthritis who were candidates for knee replacement were included in 10 centers in Germany. All subjects were asked via app on a tablet about their symptoms, prior treatments, and preferences and goals for treatment. For the subjects in the intervention group, the EKIT tool was used in the doctor-patient discussion to visualize the individual disease burden and degree of fulfillment of the indication criteria, and structured information on knee arthroplasty was provided. In the control group, the discussion was conducted without the EKIT tool in accordance with the local standard in each participating center. The primary endpoint was the quality of the patient's decision on the basis of the discussion of indications, as measured with the Hip and Knee Quality Decision Instrument (HK-DQI). (Registration number: ClinicalTrials.gov:NCT04837053). RESULTS: 1092 patients were included, and data from 1055 patients were analyzed (616 in the intervention group and 439 in the control group). Good decision quality, as rated by the HKDQI, was achieved by 86.0% of patients in the intervention group and 67.4% of patients in the control group (relative risk, 1.24; 95 % confidence interval, [1.15; 1.33]). CONCLUSION: A digital decision aid significantly improved the quality of decision-making for or against knee replacement surgery. The widespread use of this instrument may have an even larger effect, as this trial was conducted mainly in hospitals with high case numbers.

Evidence-based and Patient-centered Indication for Knee Arthroplasty - Update of the Guideline. / Evidenzbasierte und patientenorientierte Indikationsstellung zur Knieendoprothese ­ Update der Leitlinie.

Knee arthroplasty is one of the most frequently performed operations in Germany, with approximately 170000 procedures per year. It is therefore essential that physicians should adhere to an appropriate, and patient-centered indication process. The updated guideline indication criteria for knee arthroplasty (EKIT-Knee) contain recommendations, which are based on current evidence and agreed upon by a broad consensus panel. For practical use, the checklist has also been updated.For this guideline update, a systematic literature research was conducted in order to analyse (inter-)national guidelines and systematic reviews focusing on osteoarthritis of the knee and knee arthroplasty, to answer clinically relevant questions on diagnostic, predictors of outcome, risk factors and contraindications.Knee arthroplasty should solely be performed in patients with radiologically proven moderate or severe osteoarthritis of the knee (Kellgren-Lawrence grade 3 or 4), after previous non-surgical treatment for at least three months, in patients with high subjective burden with regard to knee-related complaints and after exclusion of possible contraindications (infection, comorbidities, BMI ≥ 40 kg/m2). Modifiable risk factors (such as smoking, diabetes mellitus, anaemia) should be addressed and optimised in advance. After meeting current guideline indications, a shared decision-making process between patients and surgeons is recommended, in order to maintain high quality surgical management of patients with osteoarthritis of the knee.The update of the S2k-guideline was expanded to include unicondylar knee arthroplasty, the preoperative optimisation of modifiable risk factors was added and the main indication criteria were specified.

Girdlestone resection arthroplasty for femoral neck fractures has poorer outcomes than hemiarthroplasty in frail patients with increased risk for arthroplasty-related complications: a retrospective case study of 21 patients.

BACKGROUND AND PURPOSE: Hemiarthroplasty (HA) is the usual treatment for displaced femoral neck fractures (FNF) in elderly patients. Patients may be unsuitable for HA due to secondary conditions such as systemic infections or severe neurological conditions, which is why Girdlestone resection arthroplasty (GRA) may be an option. We aimed to determine (1) patient survival in matched patient groups treated with either GRA or HA and (2) functional outcomes. PATIENTS AND METHODS: 21 patients treated with GRA for FNF in a German university hospital were retrospectively reviewed (2015-2019). After matching for age and comorbidities, a control group of 42 HA patients was established. Patient survival was determined by a Kaplan-Meier analysis. The mean follow-up (FU) was 1.5 (0-4.4) years. Function at FU was documented using the modified Harris Hip Score (mHHS) and the National Hip Fracture Database (NHFD) mobility score. RESULTS: The 1-month-mortality was 19% in the GRA group and 12% in the HA group; the 1-year mortality was 71% and 49%, respectively (P = 0.01). The mHHS at FU was lower in the GRA group than in the HA group (22 [range 0-50] vs. 46 [11-80]). 82% of patients in the GRA group were bedridden post-surgery as opposed to 19% in the HA group. CONCLUSION: Patients with HA after FNF had higher survival and better functional outcomes when compared with GRA in matched patient groups. Considering this, GRA for FNF should be selected restrictively.

Two-Year Results of Injectable Matrix-Associated Autologous Chondrocyte Transplantation in the Hip Joint: Significant Improvement in Clinical and Radiological Assessment.

PURPOSE: Articular cartilage defects are a prevalent consequence of femoroacetabular impingement (FAI) in young active patients. In accordance with current guidelines, large chondral lesions of the hip joint over 2 cm2 are recommended to be treated with matrix-associated, autologous chondrocyte transplantation (MACT); however, the conditions in the hip joint are challenging for membrane-based MACT options. Injectable MACT products can solve this problem. The purpose of the trial was to assess clinical and radiological outcomes 24 months after injectable MACT of focal chondral lesions caused by FAI. METHODS: We present data of 21 patients with focal cartilage defects of the hip [3.0 ± 1.4 cm2 (mean ± SD)], ICRS Grade III and IV caused by CAM-type impingement, who underwent arthroscopic MACT (NOVOCART® Inject) and FAI correction. The outcome was evaluated with the patient-reported outcome instruments iHOT33 and EQ-5D-5L (index value and VAS), whilst graft morphology was assessed based on the MOCART score over a follow-up period of 24 months. RESULTS: The iHOT33 score increased significantly from 52.9 ± 21.1 (mean ± SD) preoperatively to 85.8 ± 14.8 (mean ± SD; p < 0.0001) 24 months postoperatively. The EQ-5D-5L index value (p = 0.0004) and EQ-5D VAS (p = 0.0006) showed a statistically significant improvement as well. MRI evaluation after 24 months showed successful integration of the implant in all patients with a complete defect filling in 11 of 14 patients. CONCLUSIONS: Injectable MACT for the treatment of full-thickness chondral lesions of the hip joint due to FAI in combination with FAI correction improved symptoms, function, and quality of life in the treated cohort. Alongside the treatment of the underlying pathology by the FAI correction, the developed cartilage defect can be successfully repaired by MACT, which is of considerable clinical relevance.

Introduction of innovations in joint arthroplasty: Recommendations from the 'EFORT implant and patient safety initiative'.

With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 'Introduction of Innovation', combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745. Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies. Different degrees of novelty and innovation were described and agreed on in relation to when surgeons can start, using implants and implant-related instrumentation routinely. Before any clinical phase of a new implant, following the pre-market clinical investigation or the equivalent device PMCF pathway, it is a common understanding that all appropriate pre-clinical testing (regulatory mandatory and evident state of the art) - which has to be considered for a specific device - has been successfully completed. Once manufacturers receive the CE mark for a medical device, it can be used in patients routinely when a clinical investigation has been conducted to demonstrate the conformity of devices according to MDR Article 62 or full equivalence for the technical, biological and clinical characteristics has been demonstrated (MDR, Annex XIV, Part A, 3.) and a PMCF study has been initiated.

Treatment of Severe Acetabular Defects With an Antiprotrusio Cage and Trabecular Metal Augments - Clinical and Radiographic Results After a Mean Follow-Up of 6.6 Years.

BACKGROUND: Large acetabular bone defects present a serious challenge in revision total hip arthroplasty. The off-label use of antiprotrusio cages in combination with tantalum augments is a promising treatment option in these difficult situations. METHODS: Between 2008 and 2013, 100 consecutive patients underwent acetabular cup revision with a cage-augment combination in Paprosky 2 and 3 defect types (including pelvic discontinuities). There were 59 patients available for follow-up. The primary endpoint was the explantation of the cage-and-augment construct. The secondary endpoint was acetabular cup revision for any reason. Also, radiographic and functional outcomes (Western Ontario and McMaster Universities Osteoarthritis Index, Harris Hip Score) were evaluated. Implant survival rates were determined using a Kaplan-Meier analysis. The significance level was set at P < .05. RESULTS: Explantation-free survivorship of the "Cage-and-Augment" system was 91.9% after a mean follow-up of 6.2 years (range, 0 to 12.8). All 6 explantations were due to periprosthetic joint infection (PJI). The overall revision-free implant survival rate was 85.7%, including 6 additional liner revisions due to instability. In addition, 6 early PJI occurred, which were successfully treated with debridement, irrigation, and implant retention. We did observe one patient who had radiographic loosening of the construct without necessity for treatment. CONCLUSION: The combination of an antiprotrusio cage with tantalum augments is a promising technique in treating large acetabular defects. A major risk of PJI and instability due to large bone and soft tissue defects needs special attention.

Do hip resurfacing and short hip stem arthroplasties differ from conventional hip stem replacement regarding impingement-free range of motion?

Total hip joint replacement (THR) is clinically well-established. In this context, the resulting range of motion (ROM) is crucial for patient satisfaction when performing joint movements. However, the ROM for THR with different bone preserving strategies (short hip stem and hip resurfacing) raises the question of whether the ROM is comparable with conventional hip stems. Therefore, this computer-based study aimed to investigate the ROM and type of impingement for different implant systems. An established framework with computer-aided design 3D models based on magnetic resonance imaging data of 19 patients with hip osteoarthritis was used to analyse the ROM for three different implant systems (conventional hip stem vs. short hip stem vs. hip resurfacing) during typical joint movements. Our results revealed that all three designs led to mean maximum flexion higher than 110°. However, hip resurfacing showed less ROM (-5% against conventional and -6% against short hip stem). No significant differences were observed between the conventional and short hip stem during maximum flexion and internal rotation. Contrarily, a significant difference was detected between the conventional hip stem and hip resurfacing during internal rotation (p = 0.003). The ROM of the hip resurfacing was lower than the conventional and short hip stem during all three movements. Furthermore, hip resurfacing shifted the impingement type to implant-to-bone impingement compared with the other implant designs. The calculated ROMs of the implant systems achieved physiological levels during maximum flexion and internal rotation. However, bone impingement was more likely during internal rotation with increasing bone preservation. Despite the larger head diameter of hip resurfacing, the ROM examined was substantially lower than that of conventional and short hip stem.

Does Adjunction of Autologous Osteoblastic Cells Improve the Results of Core Decompression in Early-stage Femoral Head Osteonecrosis? A Double-blind, Randomized Trial.

BACKGROUND: Osteonecrosis of the femoral head (ONFH) is a disabling disease that can ultimately progress to collapse of the femoral head, often resulting in THA. Core decompression of the femoral head combined with cell therapies have shown beneficial effects in previous clinical studies in patients with early-stage (Association Research Circulation Osseous [ARCO] Stage I and II) ONFH. However, high-quality evidence confirming the efficacy of this treatment modality is still lacking. QUESTIONS/PURPOSES: (1) Is core decompression combined with autologous osteoblastic cell transplantation superior to core decompression with placebo implantation in relieving disease-associated pain and preventing radiologic ONFH progression in patients with nontraumatic early-stage ONFH? (2) What adverse events occurred in the treatment and control groups? METHODS: This study was a Phase III, multicenter, randomized, double-blind, controlled study conducted from 2011 to 2019 (ClinicalTrails.gov registry number: NCT01529008). Adult patients with ARCO Stage I and II ONFH were randomized (1:1) to receive either core decompression with osteoblastic cell transplantation (5 mL with 20 x 10 6 cells/mL in the study group) or core decompression with placebo (5 mL of solution without cells in the control group) implantation. Thirty percent (68 of 230) of the screened patients were eligible for inclusion in the study; of these, 94% (64 of 68) underwent a bone marrow harvest or sham procedure (extended safety set) and 79% (54 of 68) were treated (study group: 25 patients; control group: 29). Forty-nine patients were included in the efficacy analyses. Similar proportions of patients in each group completed the study at 24 months of follow-up (study group: 44% [11 of 25]; control: 41% [12 of 29]). The study and control groups were comparable in important ways; for example, in the study and control groups, most patients were men (79% [27 of 34] and 87% [26 of 30], respectively) and had ARCO Stage II ONFH (76% [19 of 25] and 83% [24 of 29], respectively); the mean age was 46 and 45 years in the study and control groups, respectively. The follow-up period was 24 months post-treatment. The primary efficacy endpoint was the composite treatment response at 24 months, comprising the clinical response (clinically important improvement in pain from baseline using the WOMAC VA3.1 pain subscale, defined as 10 mm on a 100-mm scale) and radiologic response (the absence of progression to fracture stage [≥ ARCO Stage III], as assessed by conventional radiography and MRI of the hips). Secondary efficacy endpoints included the percentages of patients achieving a composite treatment response, clinical response, and radiologic response at 12 months, and the percentage of patients undergoing THA at 24 months. We maintained a continuous reporting system for adverse events and serious adverse events related to the study treatment, bone marrow aspiration and sham procedure, or other study procedures throughout the study. A planned, unblinded interim analysis of efficacy and adverse events was completed at 12 months. The study was discontinued because our data safety monitoring board recommended terminating the study for futility based on preselected futility stopping rules: conditional power below 0.20 and p = 0.01 to detect an effect size of 10 mm on the 100-mm WOMAC VA3.1 pain subscale (improvement in pain) and the absence of progression to fracture (≥ ARCO Stage III) observed on radiologic assessment, reflecting the unlikelihood that statistically beneficial results would be reached at 24 months after the treatment. RESULTS: There was no difference between the study and control groups in the proportion of patients who achieved a composite treatment response at 24 months (61% [14 of 23] versus 69% [18 of 26]; p = 0.54). There was no difference in the proportion of patients with a treatment response at 12 months between the study and control groups (14 of 21 versus 15 of 23; p = 0.92), clinical response (17 of 21 versus 16 of 23; p = 0.38), and radiologic response (16 of 21 versus 18 of 23; p = 0.87). With the numbers available, at 24 months, there was no difference in the proportion of patients who underwent THA between the study and control groups (24% [six of 25] versus 14% [four of 29]). There were no serious adverse events related to the study treatment, and only one serious adverse event (procedural pain in the study group) was related to bone marrow aspiration. Nonserious adverse events related to the treatment were rare in the study and control groups (4% [one of 25] versus 14% [four of 29]). Nonserious adverse events related to bone marrow or sham aspiration were reported by 15% (five of 34) of patients in the study group and 7% (two of 30) of patients in the control group. CONCLUSION: Our study did not show any advantage of autologous osteoblastic cells to improve the results of core decompression in early-stage (precollapse) ONFH. Adverse events related to treatment were rare and generally mild in both groups, although there might have been a potential risk associated with cell expansion. Based on our findings, we do not recommend the combination of osteoblastic cells and core decompression in patients with early-stage ONFH. Further, well-designed studies should be conducted to explore whether other treatment modalities involving a biological approach could improve the overall results of core decompression. LEVEL OF EVIDENCE: Level II, therapeutic study.

[Hip dysplasia: What influence do age, arthrosis and concomitant diseases have on the treatment result?] / Hüftdysplasie im Grenzbereich: Welchen Einfluss haben Alter, Arthrose und Begleiterkrankungen auf das Behandlungsergebnis?

Pelvic osteotomies are an established treatment for symptomatic adult hip dysplasia with a promising long-term outcome. Results depend not only on the achieved acetabular reorientation but also on patient-factors like preoperative joint condition (degree of osteoarthritis and joint congruency) and age. Additionally, the diagnosis and appropriate therapy of impingement-associated hip deformities is essential in order to achieve good mid- and long-term outcomes. The influence of chondrolabral pathology on the outcome of pelvic osteotomies is not yet defined. Symptomatic patients with residual dysplasia after previous pelvic or acetabular osteotomies can benefit from an additional osteotomy, although results can be worse in comparison to prior unoperated joints. Obesity can make surgery more demanding and increases the complication profile of PAO, although it has no influence on the postoperative outcome. Regarding the overall prognosis after an osteotomy, the consideration of combined risk factors is superior to the concentration on individual factors alone.

Long-Term Mortality of Patients With Osteoarthritis After Joint Replacement: Prognostic Value of Preoperative and Postoperative Pain and Function.

OBJECTIVE: To investigate whether osteoarthritis (OA)-specific assessment values (i.e., Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) and generic pain and function (visual analog scale, Hanover Functionality Status Questionnaire) measured before and 12 months after arthroplasty are associated with the risk of long-term mortality in a cohort of patients with advanced OA of the hip or knee. METHODS: The Ulm Osteoarthritis Study was a prospective cohort study of OA patients with unilateral total hip or knee replacement between January 1995 and December 1996. Correlation coefficients were calculated to describe the agreement between the different assessments. Mortality was assessed during the follow-up period (last update July 2019). Cox proportional regression models were used to estimate hazard ratios (HRs) for mortality after adjusting for covariates. RESULTS: Arthroplasty was accompanied by a clear reduction in pain and improved function throughout all assessments in the 706 included patients. The results of the adjusted Cox models showed no relationship between baseline and follow-up joint-specific WOMAC assessments and long-term mortality. However, an independent increased risk of mortality was found with generic function assessments. In the final adjusted model, the HR for the 12-month follow-up value was 1.79 (95% confidence interval 1.24-2.60) in the group with clinically relevant impairment versus the reference group. CONCLUSION: Poor function based on the generic assessment was associated with increased long-term mortality, suggesting that functional impairments in daily life activities may be more important for long-term survival than OA-specific impairments in this patient group.

Dual-Mobility Cups in Primary Total Hip Arthroplasty. / Tripolare Pfannen in der Primärhüftendoprothetik.

Dual-mobility cups (DMCs) were introduced in France more than 40 years ago and are increasingly used not only in hip revision but also primary hip arthroplasty. Due to a simulated large-head articulation and increased jumping distance, DMCs can contribute to a high range of motion in the hip joint and reduce the risk of instability. Numerous studies have reported low dislocation rates and high survival rates in the mid-term follow-up. Nevertheless, long-term data, especially on primary hip replacement, remain limited, and the effect of recent designs and material innovations is still unclear. Therefore, primary DMCs are mainly proposed in patients at high risk for dislocation (i.e. pelvitrochanteric insufficiency, compromised spinopelvic mobility, neuromuscular disorders, obesity and femoral neck fractures). Based on a review of recently published studies referring to these indications, the current study discusses the advantages and disadvantages of DMCs.

Ultrasonic bone cement removal efficiency in total joint arthroplasty revision: A computer tomographic-based cadaver study.

Polymethylmethacrylate (PMMA) removal during septic total joint arthroplasty revision is associated with a high fracture and perforation risk. Ultrasonic cement removal is considered a bone-preserving technique. Currently, there is still a lack of sound data on efficacy as it is difficult to detect smaller residues with reasonable technical effort. However, incomplete removal is associated with the risk of biofilm coverage of the residue. Therefore, the study aimed to investigate the efficiency of ultrasonic-based PMMA removal in a human cadaver model. The femoral components of a total hip and a total knee prosthesis were implanted in two cadaver femoral canals by 3rd generation cement fixation technique. Implants were then removed. Cement mantle extraction was performed with the OSCAR-3-System ultrasonic system (Orthofix®). Quantitative analysis of cement residues was carried out with dual-energy and microcomputer tomography. With a 20 µm resolution, in vitro microcomputer tomography visualized tiniest PMMA residues. For clinical use, dual-energy computer tomography tissue decomposition with 0.75 mm resolution is suitable. With ultrasound, more than 99% of PMMA was removed. Seven hundred thirty-four residues with a mean volume of 0.40 ± 4.95 mm3 were identified with only 4 exceeding 1 cm in length in at least one axis. Ultrasonic cement removal of PMMA was almost complete and can therefore be considered a highly effective technique. For the first time, PMMA residues in the sub-millimetre range were detected by computer tomography. Clinical implications of the small remaining PMMA fraction on the eradication rate of periprosthetic joint infection warrants further investigations.

[Strategies for cup revision]. / Strategien für die Pfannenrevision.

Hip arthroplasty revision management can range from simple procedures using standard implants to complex surgical interventions requiring the combined use of revision cups, metal augments, bone grafts, and antiprotrusio cages. The adequate restoration of biomechanics and function of the hip joint with reconstruction of the original center of rotation can be challenging. We present an overview of various available techniques with the associated implant and anchoring strategies and the respective clinical results depending on the acetabular defect situation.

Framework and baseline examination of the German National Cohort (NAKO).

The German National Cohort (NAKO) is a multidisciplinary, population-based prospective cohort study that aims to investigate the causes of widespread diseases, identify risk factors and improve early detection and prevention of disease. Specifically, NAKO is designed to identify novel and better characterize established risk and protection factors for the development of cardiovascular diseases, cancer, diabetes, neurodegenerative and psychiatric diseases, musculoskeletal diseases, respiratory and infectious diseases in a random sample of the general population. Between 2014 and 2019, a total of 205,415 men and women aged 19-74 years were recruited and examined in 18 study centres in Germany. The baseline assessment included a face-to-face interview, self-administered questionnaires and a wide range of biomedical examinations. Biomaterials were collected from all participants including serum, EDTA plasma, buffy coats, RNA and erythrocytes, urine, saliva, nasal swabs and stool. In 56,971 participants, an intensified examination programme was implemented. Whole-body 3T magnetic resonance imaging was performed in 30,861 participants on dedicated scanners. NAKO collects follow-up information on incident diseases through a combination of active follow-up using self-report via written questionnaires at 2-3 year intervals and passive follow-up via record linkages. All study participants are invited for re-examinations at the study centres in 4-5 year intervals. Thereby, longitudinal information on changes in risk factor profiles and in vascular, cardiac, metabolic, neurocognitive, pulmonary and sensory function is collected. NAKO is a major resource for population-based epidemiology to identify new and tailored strategies for early detection, prediction, prevention and treatment of major diseases for the next 30 years.

The incidence of adverse local tissue reaction due to head taper corrosion after total hip arthroplasty using V40 taper and 36 mm CoCr head.

AIMS: Head-taper corrosion is a cause of failure in total hip arthroplasty (THA). Recent reports have described an increasing number of V40 taper failures with adverse local tissue reaction (ALTR). However, the real incidence of V40 taper damage and its cause remain unknown. The aim of this study was to evaluate the long-term incidence of ALTR in a consecutive series of THAs using a V40 taper and identify potentially related factors. METHODS: Between January 2006 and June 2007, a total of 121 patients underwent THA using either an uncemented (Accolade I, made of Ti12Mo6Zr2Fe; Stryker, USA) or a cemented (ABG II, made of cobalt-chrome-molybdenum (CoCrMo); Stryker) femoral component, both with a V40 taper (Stryker). Uncemented acetabular components (Trident; Stryker) with crosslinked polyethylene liners and CoCr femoral heads of 36 mm diameter were used in all patients. At a mean folllow-up of 10.8 years (SD 1.1), 94 patients (79%) were eligible for follow-up (six patients had already undergone a revision, 15 had died, and six were lost to follow-up). A total of 85 THAs in 80 patients (mean age 61 years (24 to 75); 47 (56%) were female) underwent clinical and radiological evaluation, including the measurement of whole blood levels of cobalt and chrome. Metal artifact reduction sequence MRI scans of the hip were performed in 71 patients. RESULTS: A total of 20 ALTRs were identified on MRI, with an incidence of 26%. Patients with ALTR had significantly higher median Co levels compared with those without ALTR (2.96 µg/l (interquartile range (IQR) 1.35 to 4.98) vs 1.44 µg/l (IQR 0.79 to 2.5); p = 0.019). Radiological evidence of osteolysis was also significantly associated with ALTR (p = 0.014). Median Cr levels were not significantly higher in those with ALTR compared with those without one (0.97 µg/l (IQR 0.72 to 1.9) v 0.67 µg/l (IQR 0.5 to 1.19; p = 0.080). BMI, sex, age, type of femoral component, head length, the inclination of the acetabular component, and heterotopic ossification formation showed no significant relationship with ALTR. CONCLUSION: Due to the high incidence of local ALTR in our cohort after more than ten years postoperatively, we recommend regular follow-up investigation even in asymptomatic patients with V40 taper and metal heads. As cobalt levels correlate with ALTR occurrence, routine metal ion screening and consecutive MRI investigation upon elevation could be discussed. Cite this article: Bone Joint J 2022;104-B(7):852-858.

Indication Criteria for Total Hip Arthroplasty in Patients with Hip Osteoarthritis-Recommendations from a German Consensus Initiative.

Background: Osteoarthritis of the hip (hip OA) is a leading cause of pain and disability in elderly people. If non-surgical therapies become ineffective, patients may consider total hip arthroplasty (THA). The biggest challenge in recommending a THA is identifying patients for whom the benefits of this procedure outweigh the potential risks. The aim of this initiative was to develop a clinical practice guideline with accompanying algorithm to guide consultations on THA, supported by a pocket-sized checklist. Methods: The initiative "Evidence- and consensus-based indication criteria for total hip replacement (EKIT-Hip)" used a stepwise approach, starting with an inauguration workshop, where a multidisciplinary German stakeholder panel from various scientific societies agreed on the working process. A Project Coordinating Group (PCG) was formed, and it performed a comprehensive systematic literature search of guidelines and systematic reviews related to the indication criteria for THA, as well as factors influencing outcomes. Based on best-available evidence, preliminary recommendations were formulated by the PCG and discussed with the stakeholder panel during a consensus meeting. In addition, the panel was asked to assess the feasibility of an extracted algorithm and to approve a final checklist. Results: In total, 31 recommendations were approved by 29 representatives of 23 societies. These were used to underpin an algorithm (EKIT-Algorithm), which indicates the minimum requirements for a THA (confirmed diagnosis of hip OA, present and documented individual burden of illness, ineffectiveness of non-surgical therapies, and absence of any contraindications). Once these criteria are fulfilled, further considerations should encompass the medical implications of modifiable risk factors and patients' individual treatment goals, as discussed during shared decision making. The subsequently developed checklist (EKIT-Checklist) lists relevant criteria for decision making. Conclusions: Adherence to the EKIT-Algorithm, conveniently accessed via the EKIT-Checklist, should improve the standardization of decision making leading to a recommendation for THA. By applying minimum requirements and patient-related risk factors, as well as considering patients' individual goals, it is possible to identify patients for whom the benefits of THA may exceed the potential risks.