Impact of fixation method on femoral bone loss: a retrospective evaluation of stem loosening in first-time revision total hip arthroplasty among two hundred and fifty five patients.

PURPOSE: Implant loosening represent the most common indication for stem revision in hip revision arthroplasty. This study compares femoral bone loss and the risk of initial revisions between cemented and uncemented loosened primary stems, investigating the impact of fixation method at primary implantation on femoral bone defects. METHODS: This retrospective study reviewed 255 patients who underwent their first revision for stem loosening from 2010 to 2022, receiving either cemented or uncemented stem implants. Femoral bone loss was preoperatively measured using the Paprosky classification through radiographic evaluations. Kaplan-Meier analysis estimated the survival probability of the original stem, and the hazard ratio assessed the relative risk of revision for uncemented versus cemented stems in the first postoperative year and the following two to ten years. RESULTS: Cemented stems showed a higher prevalence of significant bone loss (type 3b and 4 defects: 32.39% vs. 2.72%, p < .001) compared to uncemented stems, which more commonly had type 1 and 2 defects (82.07% vs. 47.89%, p < .001). In our analysis of revision cases, primary uncemented stems demonstrated a 20% lower incidence of stem loosening in the first year post-implantation compared to cemented stems (HR 0.8; 95%-CI 0.3-2.0). However, the incidence in uncemented stems increased by 20% during the subsequent years two to ten (HR 1.2; 95%-CI 0.7-1.8). Septic loosening was more common in cemented stems (28.17% vs. 10.87% in uncemented stems, p = .001). Kaplan-Meier analysis indicated a modestly longer revision-free period for cemented stems within the first ten years post-implantation (p < .022). CONCLUSION: During first-time revision, cemented stems show significantly larger femoral bone defects than uncemented stems. Septic stem loosening occurred 17.30% more in cemented stems.

Implant-derived CoCrMo alloy nanoparticle disrupts DNA replication dynamics in neuronal cells.

The complexity of cobalt-chromium-molybdenum (CoCrMo) nanoparticles generated from the hip modular taper interfaces resulted in inconclusive outcomes on the level of toxicity in orthopedic patients. We used a hip simulator to generate physiologically relevant CoCrMo degradation products (DPs) to demonstrate the variation in the level of toxicity in neurons in comparison to processed degradation products (PDPs). The study outcomes indicate that DP induces a higher level of DNA damage in the form of double- and single-stranded DNA breaks and alkaline labile DNA adducts versus PDPs. The scientific advancements of this study are the following: (i) how DPs mimic more closely to the implant debris from hip implants in terms of bioactivity, (ii) how hip implant debris causes local and systemic issues, and (iii) methods to augment the biologic impact of implant debris. We discovered that DP is bioactive compared with PDP, and this should be considered in the toxicity evaluation related to implants. • The physicochemical characteristics of the CoCrMo is a major factor to consider for implant-related cytotoxicity or genotoxicity experimental design. • Elevated levels of intracellular ROS induced by the physiologically relevant wear particle are detrimental to the neuronal cells. • The DP can induce variation in DNA replication dynamics compared to PDP.

Halo and spillover effect illustrations for selected beneficial medical devices and drugs.

BACKGROUND: Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a 'negative halo effect,' a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a 'negative halo effect' may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1) intrauterine contraceptive devices (IUDs); 2) silicone gel-filled breast implants (SGBI); 3) metal-on-metal hip implants (MoM); and 4) the drug Tysabri. METHODS: Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events. RESULTS: We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product's safety reputation and prevalent use may take decades in the U.S., even while these products may exhibit widespread use and good safety records in other countries. CONCLUSIONS: We conclude that the 'negative halo effect' associated with a stigma, rather than an objective risk-benefit assessment of medical products can increase negative health outcomes for patients due to reduced or inappropriate product usage.

Revision of Recalled Modular Neck Rejuvenate and ABG Femoral Implants.

Modular neck femoral stems have been associated with adverse local tissue reactions (ALTR), leading to a voluntary recall, but these effects have not been well-characterized. A retrospective review of intraoperative findings and cobalt/chromium levels was performed in 103 hips undergoing revision for ALTR. The average preoperative serum cobalt level was 7.6 µg/L (range 1.1-23 µg/L) and chromium level was 1.8 µg/L (range 0.1-6.8 µg/L). Metallic sludge was noted in 100%, synovitis in 98%, pericapsular rind in 82%, and calcar erosion in 85%. An osteotomy was required for removal in 44%. We concluded that revision of modular neck femoral stems is associated with increased preoperative metal ion levels and stem-neck corrosion. Despite advanced stem explantation techniques, osteotomy was frequently required, leading to increased morbidity.

MRI Findings Associated with Recalled Modular Femoral Neck Rejuvenate and ABG Implants.

MARS-MRI is suggested for the diagnosis of adverse local tissue reactions (ALTR) in patients with recalled femoral stems with modular necks, but there has been no major study looking at MARS-MRI findings in this population. A retrospective review was performed on 312 patients who received a modular neck hip implant between October 2007 and February 2012. 62% of patients had intra-articular effusions, with 27% containing debris. Extra-capsular effusions were present in 35% of hips. 54% had synovitis and 5.4% had osteolysis. Tendinopathy and tendon disruption was present in the gluteus medius (58%/12%), hamstring (56%/12%), gluteus minimus (38%/7.7%) and iliopsoas (7.1%/4.8%). Abnormal MARS-MRI findings are associated with modular neck femoral components and can suggest underlying ALTR. MARS-MRI abnormalities merit serious consideration in this population.

Toxicology-based cancer causation analysis of CoCr-containing hip implants: a quantitative assessment of genotoxicity and tumorigenicity studies.

In this paper, quantitative methods were used to evaluate the weight of evidence regarding a causative relationship between cobalt-chromium (CoCr)-containing hip implants and increased cancer risk. We reviewed approximately 80 published papers and identified no-observed-adverse-effect level (NOAEL) and/or lowest-observed-adverse-effect level (LOAEL) values for specific endpoints of interest: genotoxic effects from in vitro studies with human cell lines as well as genotoxicity and tumor formation in animal bioassays. Test articles included Co particles and ions, Cr particles and ions, and CoCr alloy particles as well as CoCr alloy implants. The NOAEL/LOAEL values were compared with body burdens of Co/Cr particles and ions we calculated to exist in systemic tissues of hip implant patients under normal and excessive wear conditions. We found that approximately 40 tumor bioassays have been conducted with CoCr alloy implants or Co/Cr particles and ions at levels hundreds to thousands of times higher than those present in hip implant patients, and none reported a statistically significant increased incidence of systemic tumors. Results from in vitro and in vivo genotoxicity assays, which are relatively less informative owing to false positives and other factors, also indicated that DNA effects would be highly unlikely to occur as a result of wear debris from a CoCr implant. Hence, the toxicological weight of evidence suggests that CoCr-containing hip implants are unlikely to be associated with an increased risk of systemic cancers, which is consistent with published and ongoing cancer epidemiology studies involving patients with CoCr hip implants.

Non-vertebral Mycobacterium avium complex osteomyelitis in an immunocompetent patient.

Mycobacterium avium complex (MAC) is a ubiquitous soil pathogen that is an uncommon cause of diseases in immunocompetent patients. In this case, we describe the presentation of an otherwise healthy man in his 50s presenting with months of malaise and severe hip pain, with aspiration initially yielding no bacteria and presumed fastidious infection. He was treated with irrigation and debridement, surgical stabilisation of the femoral neck and conventional broad-spectrum antibiotics with final cultures diagnostic of MAC osteomyelitis. This case serves to demonstrate the importance of clinical suspicion and appropriate workup of this unusual case of MAC hip osteomyelitis in an otherwise immunocompetent patient.

Numerical Investigation of Fatigue Behavior in Ti-6Al-4V Orthopedic Hip Implants Subjected to Different Environments.

In this paper, hip implants made of Ti-6Al-4V titanium alloy are analyzed numerically using Extended Finite Element Method XFEM. The combined effect of corrosion and fatigue was considered here since this is a common cause of failure of hip implants. Experimental testing of Ti-6Al-4V alloy was performed to determine its mechanical properties under different working environments, including normal, salty, and humid conditions. The integrity and life of the hip implant were assessed using the Linear Elastic Fracture Mechanics (LEFM) approach. For this purpose, the conditional fracture toughness Kq using CT specimens from all three groups (normal, humid, salty conditions) were determined. This provided insight into how different aggressive environments affect the behavior of Ti-6Al-4V alloy; i.e., how much its resistance to crack growth would degrade depending on conditions corresponding to the real exploitation of hip implants. Next, analytical and XFEM analyses of fatigue behavior in terms of the number of cycles were performed for all three groups, and the obtained results showed good agreement, confirming the validity of the integrity assessment approach shown in this work, which also represented a novel approach since fatigue and corrosion effects were investigated simultaneously.

Chronic abductor lesion after total hip arthroplasty in a sitting proud stem: direct repair by osteotomy of the greater trochanter.

A woman in her late 70s with bilateral total hip arthroplasty (THA) presented with left hip pain arising immediately after the last THA procedure, progressively worsening. Clinically, a severe abductor insufficiency with Trendelenburg limp was observed. Moreover, symptomatic leg length discrepancy required a contralateral heel lift of 0.5 cm. She was previously managed conservatively without any clinical benefit. Radiographs showed a well-fixed uncemented straight, sitting proud stem. MRI showed a large abductor tear. A minimally invasive proximal advancement of the greater trochanter was planned to allow direct surgical repair of the abductor lesion. The patient made a good recovery, and 12 months after surgery, wire removal was performed. The patient gained significant improvements in hip function (Harris Hip Score from 52 to 89), full limp recovery and complete pain relief at 13 months follow-up from primary surgery.

In Vitro Tribocorrosion Evaluation of Carbide-derived Carbon (CDC) for Hip Implants.

Carbide-derived carbon (CDC) was previously proposed as a surface modification method for hip implant applications since it showed excellent tribocorrosion performance under open-circuit potential (OCP) conditions. Nonetheless, a systematic evaluation of CDC's tribocorrosion properties was still missing. Therefore, our objective is to test CDC's tribocorrosion performance under various electrochemical conditions and to identify the synergism between wear and corrosion. Based on the findings, the variations in OCP for CDC (0.626 mV) is smaller than Ti6Al4V (1.91 mV), and CDC showed lower induced current than T6Al4V for all potentials, suggesting CDC is more stable than Ti6Al4V under tribocorrosive conditions. Eventually, the weight loss of Ti6Al4V (50.662±5.19 µg) was found to be significantly higher than that of CDC (4.965±5.19 µg), which agrees with the electrochemical results. In summary, CDC showed better tribocorrosion performance than Ti6Al4V and was determined as an Antagonism regime.

The role of muscle forces and gait cycle discretization when assessing acetabular cup primary stability: A finite element study.

The aim of this study was to investigate the influence of the muscle force contribution and loading cycle discretization on the predicted micromotion and interfacial bone strains in the implanted acetabulum. To this end, a patient specific finite element model of the hemipelvis was developed, based on the CT-scan and gait analysis results, collected as part of the authors' previous work. Outcomes of this study suggests that the acetabular cup micromotion and interfacial bone strains can be predicted just using the joint contact force. This helps to reduce the complexity of the finite element models by ignoring the contribution of muscle forces and the associated challenges of mapping these forces to the pelvis. However, the gait cycle needs to be adequately discretised to capture the micromotion at the bone-implant interface. BACKGROUND AND OBJECTIVE: The Dalstra load case, which includes muscle forces, has been widely adopted in the literature for studying the mechanical environment in the intact and implanted acetabulum. To simplify the modelling approach, some researchers ignore the contribution of muscle forces. The Dalstra load case is also divided into eight separate load steps (five in the stance phase and three in the swing phase), however, it is unclear whether this adequately captures the micromotions, for a cementless acetabular cup, during a simulated activity. The aim of this study was to investigate the influence of the muscle force contribution and loading cycle discretization on the predicted micromotion and interfacial bone strains. METHODS: In this work, a patient specific finite element model of the hemipelvis was developed, based on the CT-scan and gait analysis results, collected as part of the authors' previous work. Finite element simulations were performed using the joint contact and muscle forces derived from two sources. The first approach was used the load case proposed by Dalstra et al. The second approach used joint contact and muscle forces predicted by a musculoskeletal model. Additionally, the musculoskeletal load case was discretised into 50 equal load steps and the results compared with the equivalent Dalstra load steps. RESULTS: The results showed that the contribution of the muscle forces resulted in minor differences in both the magnitude and distribution of the predicted acetabular micromotion (up to 4.01% in the mean acetabular micromotion) and interfacial bone strains (up to 10.34% in the mean interfacial bone strains). The degree of gait cycle discretisation had a significant influence on the acetabular micromotion with a difference of 20.89% in the mean acetabular micromotion. CONCLUSION: Outcomes of this study suggests that the acetabular cup micromotion and interfacial bone strains can be predicted just using the joint contact force. This helps to reduce the complexity of the finite element models by ignoring the contribution of muscle forces and the associated challenges of mapping these forces to the pelvis. However, the gait cycle needs to be adequately discretised to capture the micromotion at the bone-implant interface.

Revision Arthroplasty for Bilateral McKee-Farrar Hip Prostheses 48 Years Following Implantation.

The McKee-Farrar hip prosthesis gained popularity in the 1960s and was one of the first widely used prostheses to employ a metal-on-metal design. Eventually, it laid the framework for the development of second and third-generation hip replacement prostheses. In time, the McKee-Farrar prosthesis was found to have high rates of early aseptic loosening and fell out of favor, especially with the development of the Charnley low-friction metal-on-polyethylene design. We present an interesting case of a patient who underwent bilateral total hip arthroplasty with a McKee-Farrar hip prostheses at the young age of 28 years, in view of secondary hip osteoarthritis resulting from ankylosing spondylitis. The implants lasted approximately 48 years after initial implantation in this case, which is an unusually long survival of this prosthesis. He presented to us at the age of 76 years with groin pain and difficulty to weight-bear, worse on the right side. Significant osteolysis around the acetabular component was noted, greater on the right side. Infection was excluded, and the patient underwent staged revision bilateral hip replacements one year apart. Extraction of the femoral components on both sides was done with the aid of extended trochanteric osteotomies. For both revisions, uncemented acetabular revision shells (TMARS, Zimmer Biomet, Warsaw, Indiana) were used for the acetabulum and long uncemented diaphyseal engaging interlocked stems (Arcos ILS, Zimmer Biomet) were used for the femoral side. No complications were encountered during the procedures. The patient made excellent progress following the procedures with immediate weight-bearing, as tolerated, and physiotherapy input. No subsequent postoperative complications occurred till the time of the patient's death five years later from unrelated medical causes. It is rare to encounter and revise the McKee-Farrar prosthesis in modern orthopaedic practice. This, to the best of our knowledge, is the longest-described survival of this prosthesis in literature.

Simultaneous above-knee amputation and ipsilateral total hip arthroplasty in a neglected neck of femur fracture with an insensate limb.

Total hip arthroplasty (THA) in patients with ipsilateral mid-thigh amputation is surgically challenging. We report a case of same setting THA and ipsilateral above-knee amputation in a male patient. The patient had 8 months old neglected neck femur fracture and ipsilateral femur shaft fracture with 14 cm bone loss. There was an associated neurovascular (femoral artery injury and sciatic nerve palsy) deficit at the initial insult; however, the limb survived because of well-formed collaterals. The limb was insensate at the time of presentation because of complete sciatic nerve palsy. The decision to undergo amputation was taken based on insensate limb, compromised circulation and huge bone loss with healed open fracture. After 10 months follow-up, the patient was walking with prosthesis limb fitted to the amputated mid-thigh stump and there were no incidences of osteolysis, subsidence or infection in the THA site.

Comprehensive Review on Biomaterials and Their Inherent Behaviors for Hip Repair Applications.

Developing biomaterials for hip prostheses is challenging and requires dedicated attention from researchers. Hip replacement is an inevitable and remarkable orthopedic therapy for enhancing the quality of patient life for those who have arthritis as well as trauma. Generally, five types of hip replacement procedures are successfully performed in the current medical market: total hip replacements, hip resurfacing, hemiarthroplasty, bipolar, and dual mobility systems. The average life span of artificial hip joints is about 15 years, and several studies have been conducted over the last 60 years to improve the performance and thereby increase the lifespan of artificial hip joints. Present-day prosthetic hip joints are linked to the wide availability of biomaterials. Metals, ceramics, and polymers are some of the most promising types of biomaterials; nevertheless, each biomaterial has advantages and disadvantages. Metals and ceramics fail in most applications owing to stress shielding and the emission of wear debris; ongoing research is being carried out to find a remedy to these unfavorable responses. Recent research found that polymers and composites based on polymers are significant alternative materials for artificial joints. With growing research and several biomaterials, recent reviews lag in effectively addressing hip implant materials' individual mechanical, tribological, and physiological behaviors. This Review comprehensively investigates the historical evolution of artificial hip replacement procedures and related biomaterials' mechanical, tribological, and biological characteristics. In addition, the most recent advances are also discussed to stimulate and guide future researchers as they seek more effective methods and synthesis of innovative biomaterials for hip arthroplasty application.

Fracture of a titanium femoral neck after revision total hip arthroplasty.

We report a case of a fractured titanium alloy (Ti6Al4V) femoral stem 2 years after revision (debridement, antibiotics and implant retention due to periprosthetic joint infection) total hip arthroplasty (THA). Material analysis revealed a superficial abnormality on the upper neck surface caused by local melting with electrocautery probably acting as a stress amplifier. This lesion presumably was the trigger of a fatigue fracture with typical features on the fracture surface. Electrocautery should therefore be avoided in case of revision THA or used with utmost care to avoid contact with the femoral stem.

Denosumab in Cementless Total Hip Arthroplasty: Multivariate Reanalysis of 3D Femoral Stem Migration and the Influence on Outliers.

In cementless total hip arthroplasty, adequate implant stability is necessary for the success of osseointegration and rapid clinical recovery. Postoperative femoral stem migration, measured by radiostereometric analysis (RSA), defines the initial stability achieved during surgical implantation. In a recent trial of 65 postmenopausal women randomized 1:1 denosumab:placebo, denosumab failed to reduce the initial migration of a cementless femoral stem despite the successful prevention of periprosthetic bone loss. The trial applied the current RSA standard, which examined stem migration on an axis-by-axis basis and did not consider more complex three-dimensional (3D) migration. Therefore, we performed a reanalysis of the trial data using a multivariate hierarchical linear mixed model (LMM). As an additional limitation, the data included influential outliers. Women with normal bone mineral density exhibited significantly (p = 0.036) less stem subsidence compared with osteopenic and osteoporotic women. Denosumab significantly decreased the variance of stem migration in osteopenic and osteoporotic women. The mean magnitude of 3D stem migration did not differ between denosumab-treated and placebo-treated women (p = 0.820). After application of a common statistical definition for RSA outlier identification, there were eight (12%) outliers, six in the placebo group and two in the denosumab group (p = 0.149). After exclusion of the outliers, the repeated LMM analysis demonstrated a trending difference in 3D stem migration (p = 0.086), with a significant difference of z-axis rotation (valgus-varus tilt) of the femoral stem (p = 0.029). The observed effect size was small and without clinically important differences in postoperative recovery. Based on a Monte Carlo simulation with random-generated 3D migration data, multivariate LMM showed greater statistical power than univariate analyses. The application of hierarchical LMM facilitated the analysis of implant migration as a factual 3D event. The observed trend in the lower number of RSA outliers in denosumab-treated subjects warrants powered large-scale trials. © 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Non-ischaemic cardiomyopathy associated with elevated serum cobalt and accelerated wear of a metal-on-metal hip resurfacing.

A man in his late 30s developed non-ischaemic cardiomyopathy due to systemic cobalt toxicity associated with accelerated bearing surface wear from metal-on-metal hip resurfacing implanted in the previous 6 years. Following revision arthroplasty, the patient regained baseline cardiac function. Cobalt-induced cardiomyopathy is a grave condition that deserves early consideration due to potentially irreversible morbidity. We present this case to increase awareness, facilitate early detection and emphasise the need for research into the diagnosis and management of at-risk patients.

Hypercalcaemia caused by calcium sulfate beads.

Hypercalcaemia is a relatively common metabolic disturbance seen in hospitalised patients; however, given the complicated systems of calcium regulation, it can take a significant amount of time and testing to pinpoint the aetiology. This case discusses a patient who developed acute hypercalcaemia from calcium sulfate-containing antibiotic beads placed during an orthopaedic procedure. These beads are used in surgical procedures to fill gaps/voids in bony structures and for local delivery of antibiotics. The case highlights the importance of careful review of a patient's hospital course, including the administration of medical products that may not be clearly documented on a patient's medicine administration record when working up an unexplained finding.

Prosthetic hip infection due to Campylobacter jejuni.

A woman in her 60s with a left hip prosthesis was presented with left hip pain and fever. She had an elevated white blood cell count and inflammatory markers. Synovial fluid Gram stain demonstrated curved Gram-negative rods identified as Campylobacter jejuni The patient initially refused surgery and after 3 months underwent one-stage exchange after which she was treated with 12 weeks of levofloxacin. Her inflammatory markers normalised and she was clinically doing well at her 6-month follow-up. C. jejuni is a rare cause of prosthetic joint infection and should be included in the differential diagnosis when a patient has risk factors even without significant preceding gastrointestinal symptoms. Per most recent Infectious Diseases Society of America guidelines, treatment after one-stage revision includes 4-6 weeks of intravenous antimicrobials followed by possible oral suppression therapy, while the European guidelines recommend 12 weeks of orally bioavailable antibiotics.

The Role of the Assembly Force in the Tribocorrosion Behaviour of Hip Implant Head-Neck Junctions: An Adaptive Finite Element Approach.

The cyclic loading, in the corrosive medium of the human body, results in tribocorrosion at the interface of the head-neck taper junction of hip implants. The resulting metal ions and wear debris adversely affect the local tissues. The force applied by surgeons to assemble the junction has proven to play a major role in the mechanics of the taper junction which, in turn, can influence the tribocorrosion damage. Recently, finite element method has been used to predict the material loss at the head-neck interface. However, in most finite element studies, the contribution of electrochemical corrosion has been ignored. Therefore, a detailed study to investigate the influence of the assembly force on the tribocorrosive behaviour of the head-neck junction, which considers both the mechanical and chemical material removal, is of paramount interest. In this study, a finite-element-based algorithm was used to investigate the effect of assembly force on the tribocorrosion damage at the junction interface, for over four million cycles of simulated level gait. The patterns of the material removal in the modelling results were compared with the damage patterns observed in a group of retrieved modular hip implants. The results of this study showed that for different cases, chemical wear was in the range of 25-50% of the total material loss, after four million cycles. A minimum assembly force (4 kN for the studied cases) was needed to maintain the interlock in the junction. The computational model was able to predict the damage pattern at the retrieved head-neck interface.