Two-Year Results of Ceramic-on-Ceramic Hip Resurfacing in an International Multicenter Cohort.

BACKGROUND: Hip resurfacing arthroplasty (HRA) is a bone-conserving alternative to total hip arthroplasty. We present the 2-year clinical and radiographic follow-up of a novel ceramic-on-ceramic HRA in an international multicenter cohort. METHODS: Patients undergoing HRA between September 2018 and January 2021 were prospectively included. Patient-reported outcome measures (PROMs) in the form of the Forgotten Joint Score, Hip Disability and Osteoarthritis Outcome Score Jr., Western Ontario and McMaster Universities Arthritis Index, Oxford Hip Score, and University of California, Los Angeles, Activity Score were collected preoperatively, and at 1 and 2 years postoperation. Serial radiographs were assessed for migration, component alignment, evidence of osteolysis or loosening, and heterotopic ossification formation. RESULTS: The study identified 200 patients who reached a minimum 2-year follow-up (mean 3.5 years). Of these, 185 completed PROMs follow-up at 2 years. There was a significant improvement in Hip Disability and Osteoarthritis Outcome Score (P < .001) and Oxford Hip Score (P < .001) between the preoperative, 1-year, and 2-year outcomes. Patients had improved activity scores on the University of California, Los Angeles, Active Score (P < .001), with 45% reporting a return to high-impact activity at 2 years. At 1 and 2 years, the Forgotten Joint Score was not significantly different (P = .38). There was no migration, osteolysis, or loosening of any of the implants. No fractures were reported over the 2-year follow-up, with only 1 patient reporting a sciatic nerve palsy. There were 2 revisions, 1 for unexplained pain at 3 months due to acetabular component malposition and 1 at 33.5 months for acetabular implant failure. CONCLUSIONS: The ceramic-on-ceramic resurfacing at 2 years postoperation demonstrates promising results with satisfactory outcomes in all recorded PROMs. Further long-term data are needed to support the widespread adoption of this prosthesis as an alternative to other HRA bearings.

Assessing the Clinical Value of Objective and Patient-Reported Audiovestibular Outcome Measures in the Risk Estimation of Systemic Cobalt Toxicity for Patients With a Metal-on-Metal Hip Implant.

OBJECTIVES: Based on limited evidence from case reports and small cohort studies of metal-on-metal (MoM) hip implant patients with presumed systemic cobalt (Co) toxicity, and a few animal studies on Co-induced damage to the otovestibular system, it was hypothesised that Co exhibits an ototoxic potential alongside other systemic manifestations. Preliminary investigations from our research group in MoM patients confirmed this assumption for the auditory system, whereas no signs of Co-induced vestibular impairment were detected, and a clear dose-response relationship between the auditory function and the blood Co levels was lacking. Therefore, the current study aimed to extend and validate these findings in a larger sample of MoM patients and control subjects, to explore the potential clinical value of audiovestibular outcome measures in the risk estimation of systemic Co toxicity in this patient population. DESIGN: Fifty patients (32 to 68 years) with a primary unilateral/bilateral MoM hip implant were matched for age, gender, and noise exposure to 50 nonimplanted control subjects. Both groups underwent the same protocol, consisting of an objective auditory [i.e., conventional and high-frequency audiometry, transient-evoked and distortion (TEOAEs and DPOAEs), auditory brainstem responses] and vestibular (i.e., cervical and ocular vestibular evoked myogenic potentials, horizontal and vertical video head impulse tests) test battery, a questionnaire inquiring auditory, balance, and general neurological symptoms, and a blood sample collection to determine the plasma Co concentration. RESULTS: The auditory test battery presented consistently higher audiometric thresholds in the MoM patient group, with group differences ranging from 2.1 to 5.7 dB in the lower frequencies (0.25 to 6.0 kHz) and from 4.6 to 9.3 dB in the high frequencies (8.0 to 14.0 kHz). Group differences at high frequencies were statistically significant ( p ≤ 0.001). Additionally, significantly lower TEOAE ( p = 0.009) and DPOAE ( p < 0.001) amplitudes were observed in the MoM patients when the better ear was included in the analysis, and more absent TEOAE and DPOAE responses were found between 1.0 and 4.0 kHz (0.008 ≤ p ≤ 0.039). Within the vestibular test battery, the MoM patients showed longer N1 and P1 ocular vestibular evoked myogenic potentials latencies for the left ear, and lower video head impulse test gains for the left anterior and right posterior semicircular canals (0.005 ≤ p ≤0.035). The patient-reported (questionnaire) outcome delivered no significant group differences ( p > 0.01). Six patients had elevated Co levels according to our local institutional threshold (>4 or 5 µg/l for unilateral or bilateral MoM hip implants, resp.), but their audiovestibular outcome measures did not differ significantly from those of the other patients. CONCLUSIONS: Corresponding to our preliminary investigations, the results indicate possibly Co-induced (predominantly high-frequency) auditory impairment, probably triggered by toxic damage to the cochlear structures. However, the low mean difference values, the lack of group differences for the patient-reported outcome measures, and the lack of any relationship with the blood Co levels strongly reduce the clinical relevance of these findings. Therefore, the risk of Co-induced ototoxic impairment is considered to be clinically negligible for the majority of MoM hip implant patients, and the use of auditory tests in the risk estimation of systemic Co toxicity should be decided on a case-by-case basis.

Demographic expansion of an African opportunistic carnivore during the Neolithic revolution.

The diffusion of Neolithic technology together with the Holocene Climatic Optimum fostered the spread of human settlements and pastoral activities in North Africa, resulting in profound and enduring consequences for the dynamics of species, communities and landscapes. Here, we investigate the demographic history of the African wolf (Canis lupaster), a recently recognized canid species, to understand if demographic trends of this generalist and opportunistic carnivore reflect the increase in food availability that emerged after the arrival of the Neolithic economy in North Africa. We screened nuclear and mitochondrial DNA in samples collected throughout Algeria and Tunisia, and implemented coalescent approaches to estimate the variation of effective population sizes from present to ancestral time. We have found consistent evidence supporting the hypothesis that the African wolf population experienced a meaningful expansion concurring with a period of rapid population expansion of domesticates linked to the advent of agricultural practices.

The Ototoxic Potential of Cobalt From Metal-on-Metal Hip Implants: Objective Auditory and Vestibular Outcome.

OBJECTIVES: During the past decade, the initial popularity of metal-on-metal (MoM) hip implants has shown a progressive decline due to increasingly reported implant failure and revision surgeries. Local as well as systemic toxic side effects have been associated with excessive metal ion release from implants, in which cobalt (Co) plays an important role. The rare condition of systemic cobaltism seems to manifest as a clinical syndrome with cardiac, endocrine, and neurological symptoms, including hearing loss, tinnitus, and imbalance. In most cases described in the literature, revision surgery and the subsequent drop in blood Co level led to (partial) alleviation of the symptoms, suggesting a causal relationship with Co exposure. Moreover, the ototoxic potential of Co has recently been demonstrated in animal experiments. Since its ototoxic potential in humans is merely based on anecdotal case reports, the current study aimed to prospectively and objectively examine the auditory and vestibular function in patients implanted with a MoM hip prosthesis. DESIGN: Twenty patients (15 males and 5 females, aged between 33 and 65 years) implanted with a primary MoM hip prosthesis were matched for age, gender, and noise exposure to 20 non-implanted control subjects. Each participant was subjected to an extensive auditory (conventional and high-frequency pure tone audiometry, transient evoked and distortion product otoacoustic emissions [TEOAEs and DPOAEs], auditory brainstem responses [ABR]) and vestibular test battery (cervical and ocular vestibular evoked myogenic potentials [cVEMPs and oVEMPs], rotatory test, caloric test, video head impulse test [vHIT]), supplemented with a blood sample collection to determine the plasma Co concentration. RESULTS: The median [interquartile range] plasma Co concentration was 1.40 [0.70, 6.30] µg/L in the MoM patient group and 0.19 [0.09, 0.34] µg/L in the control group. Within the auditory test battery, a clear trend was observed toward higher audiometric thresholds (11.2 to 16 kHz), lower DPOAE (between 4 and 8 kHz), and total TEOAE (1 to 4 kHz) amplitudes, and a higher interaural latency difference for wave V of the ABR in the patient versus control group (0.01 ≤ p < 0.05). Within the vestibular test battery, considerably longer cVEMP P1 latencies, higher oVEMP amplitudes (0.01 ≤ p < 0.05), and lower asymmetry ratio of the vHIT gain (p < 0.01) were found in the MoM patients. In the patient group, no suggestive association was observed between the plasma Co level and the auditory or vestibular outcome parameters. CONCLUSIONS: The auditory results seem to reflect signs of Co-induced damage to the hearing function in the high frequencies. This corresponds to previous findings on drug-induced ototoxicity and the recent animal experiments with Co, which identified the basal cochlear outer hair cells as primary targets and indicated that the cellular mechanisms underlying the toxicity might be similar. The vestibular outcomes of the current study are inconclusive and require further elaboration, especially with respect to animal studies. The lack of a clear dose-response relationship may question the clinical relevance of our results, but recent findings in MoM hip implant patients have confirmed that this relationship can be complicated by many patient-specific factors.

Italian version of University of California at Los Angeles (UCLA) Activity Score: cross-cultural adaptation.

Over the last 10 years, patient-oriented evaluations using questionnaires have become an important aspect of clinical outcome studies. Any questionnaire must be translated and culturally adapted in order to be used with different language groups, and the translated version must then be evaluated for reliability, validity and responsiveness which are fundamental attributes of any measurement tool. The aim of this study is the validation, translation and cross-cultural adaptation of the Italian version of UCLA activity Score, following the Guillemin criteria. The results show that our Italian version of the UCLA score has the following: reproducibility expressed as ICC=0.994, an internal consistency calculated as Spearman-Brown coefficient=0.754 and finally the construct validity has demonstrated a significant Pearson's correlation coefficient with other validated hip questionnaires.

The 2012 Otto Aufranc Award: The interpretation of metal ion levels in unilateral and bilateral hip resurfacing.

BACKGROUND: The interpretation of metal ion concentrations and their role in clinical management of patients with metal-on-metal implants is still controversial. QUESTIONS/PURPOSES: We questioned whether patients undergoing hip resurfacing with no clinical problems could be differentiated from those with clinical (pain, loss of function) and/or radiographic (component malpositioning, migration, bone loss), problems based on metal ion levels, and if there was a threshold metal level that predicted the need for clinical intervention. Furthermore, we asked if patient and implant factors differed between these functional groups. METHODS: We retrospectively identified 453 unilateral and 139 bilateral patients with ion measurements at minimum followup of 12 months (mean, 4.3 years; range, 1-12.9 years). Patients were designated as well functioning or poorly functioning based on strict criteria. The acceptable upper levels within the well-functioning group were determined from the 75th percentile plus 1.5× interquartile range. The sensitivity and specificity of these levels to predict clinical problems were calculated. RESULTS: Well-functioning group ions were lower than the poorly functioning group ion levels. The acceptable upper levels were: chromium (Cr) 4.6 µg/L, cobalt (Co) 4.0 µg/L unilateral and Cr 7.4 µg/L, Co 5.0 µg/L bilateral. The specificity of these levels in predicting poor function was high (95%) and sensitivity was low (25%). There were more males in the well-functioning group and more females and smaller femoral components in the poorly functioning group. CONCLUSIONS: Metal levels higher than these proposed safe upper limits can predict problems with metal-on-metal resurfacings and are important parameters in the management of at-risk patients. LEVEL OF EVIDENCE: Level II, diagnostic study. See Guidelines for Authors for a complete description of levels of evidence.

A modified posterior approach preserves femoral head oxgenation during hip resurfacing.

In 11 patients, the oxygenation was measured in the superolateral quadrant of the femoral head during resurfacing with a modified posterior approach, designed to preserve the blood supply, using a gas-sensitive electrode. These were compared with measures from 10 patients in whom the standard posterior approach was used. The modified approach patients maintained a significantly (P < .005) higher amount of relative oxygenation after the approach, 78% (standard deviation [SD], 45%) vs 38% (SD, 26%), and acetabular component implantation, 74% (SD, 56%) vs 20% (SD, 28%). The modified posterior approach, unlike the standard extended approach, does not significantly compromise the blood supply to the head; and we recommend this approach be considered for hip resurfacing.

Histological features of pseudotumor-like tissues from metal-on-metal hips.

BACKGROUND: Pseudotumor-like periprosthetic tissue reactions around metal-on-metal (M-M) hip replacements can cause pain and lead to revision surgery. The cause of these reactions is not well understood but could be due to excessive wear, or metal hypersensitivity or an as-yet unknown cause. The tissue features may help distinguish reactions to high wear from those with suspected metal hypersensitivity. QUESTIONS/PURPOSES: We therefore examined the synovial lining integrity, inflammatory cell infiltrates, tissue organization, necrosis and metal wear particles of pseudotumor-like tissues from M-M hips revised for suspected high wear related and suspected metal hypersensitivity causes. METHODS: Tissue samples from 32 revised hip replacements with pseudotumor-like reactions were studied. A 10-point histological score was used to rank the degree of aseptic lymphocytic vasculitis-associated lesions (ALVAL) by examination of synovial lining integrity, inflammatory cell infiltrates, and tissue organization. Lymphocytes, macrophages, plasma cells, giant cells, necrosis and metal wear particles were semiquantitatively rated. Implant wear was measured with a coordinate measuring machine. The cases were divided into those suspected of having high wear and those suspected of having metal hypersensitivity based on clinical, radiographic and retrieval findings. The Mann-Whitney test was used to compare the histological features in these two groups. RESULTS: The tissues from patients revised for suspected high wear had a lower ALVAL score, fewer lymphocytes, but more macrophages and metal particles than those tissues from hips revised for pain and suspected metal hypersensitivity. The highest ALVAL scores occurred in patients who were revised for pain and suspected metal hypersensitivity. Component wear was lower in that group. CONCLUSIONS: Pseudotumor-like reactions can be caused by high wear, but may also occur around implants with low wear, likely because of a metal hypersensitivity reaction. Histologic features including synovial integrity, inflammatory cell infiltrates, tissue organization, and metal particles may help differentiate these causes. CLINICAL RELEVANCE: Painful hips with periprosthetic masses may be caused by high wear, but if this can be ruled out, metal hypersensitivity should be considered.

Complications encountered with the use of constrained acetabular prostheses in total hip arthroplasty.

At our department, 46 constrained acetabular components in 38 patients were placed successively for a period of 4 years. Indications included recurrent dislocation, septic and aseptic loosening with extensive bone loss, tumor surgery with extensive bone resection, and instability due to neurologic impairment. Because 2 cup failures and 10 dislocations were observed with the constrained devices at 4 to 7 years of follow-up, the authors started to use large-diameter metal-on-metal bearings for similar indications. A series of 36 such bearings in 38 patients revealed only one cup failure and one dislocation at 2 to 4 years of follow-up. Although the 2 series are different and therefore difficult to compare, the authors recommend judicious use of constrained devices because of the high failure rate (26%) and consideration of alternative options such as the use of large-diameter metal-on-metal bearings.

Radiographic evaluation of hip resurfacing: the role of x-rays in the diagnosis of a problematic resurfaced hip.

INTRODUCTION: Hip resurfacing (HRA) requires a new standardised radiographic evaluation protocol. Evaluation of acetabular components is similar to total hip arthroplasty (THA) but femoral components require different criteria. This study evaluates the efficacy of a new femoral zonal system for radiographic HRA assessment in identifying clinical problems. METHODS: A new proximal femoral zonal system divides implant-cement-bone interfaces at head and neck into 7 DeSmet zones. 611 in situ and 100 revised HRA were assessed for component positioning, borderline findings (reactive lines, cortical thickening, cancellous condensation) or sinister findings (lucent lines, bone resorption, osteolysis). Findings were correlated with gender, size, implant survival, clinical scores, metal ions, and adverse soft tissue reactions (ALTR). RESULTS: Radiological changes were found in 265 hips (37.3%), 154 sinister (21.7%) and 111 borderline (15.6%). 84% of revisions had sinister findings versus 11.4% of in situ HRA (p < 0.001). The mean number of abnormal acetabular and femoral zones was 3.3 in revised compared to 0.6 in situ HRA (p < 0.001). Sinister findings were associated with female gender, lower clinical scores, smaller sizes or ASR design (all: p < 0.001). Metal ions were higher with sinister (p < 0.001) and borderline (p < 0.01) findings compared to normal radiographs. Pathological findings in ⩾4 zones had a sensitivity of 50% and specificity of 94.2% (AUC = 0.898) in detecting hips with ALTR (odds ratio = 49). CONCLUSION: In order to accurately evaluate progressive radiographic changes in HRA, specific zones have been established around the femoral component. There was a high correlation between radiographic findings and outcome measures. 84% of problematic hips and 90.4% of proven ALTR had sinister changes.

Does intraoperative cell salvage remove cobalt and chromium from reinfused blood?

In 12 patients undergoing a revision hip arthroplasty after a failed metal-on-metal primary hip arthroplasty, the effectiveness of intraoperative cell salvage (ICS) in removing metal ions was investigated. Samples of blood collected during surgery were filtered using 2 ICS devices. The samples had the concentrations of cobalt (Co) and chromium (Cr) measured before and after filtration. There was an average reduction of 76.3% for Cr concentration and 78.6% for Co concentration after ICS filtering. The Co-to-Cr ratio before and after filtration was similar. At the present time, these salvage systems should be used with caution in the patient undergoing revision of metal-on-metal bearing surfaces.

Hip resurfacing arthroplasty complicated by mismatched implant components.

Metal-on-metal hip resurfacing has gained popularity as a feasible treatment option for young and active patients with hip osteoarthritis and high functional expectations. This procedure should only be performed by surgeons who have trained specifically in this technique. Preoperative planning is essential for hip resurfacing in order to execute a successful operation and preview any technical problems. The authors present a case of a man who underwent a resurfacing arthroplasty for osteoarthritis of the left hip that was complicated by mismatched implant components that were revised three days afterwards for severe pain and leg length discrepancy. Such mistakes, although rare, can be prevented by educating operating room staff in the size and colour code tables provided by the companies on their prostheses or implant boxes.

Current expert views on metal-on-metal hip resurfacing arthroplasty. Consensus of the 6th advanced Hip resurfacing course, Ghent, Belgium, May 2014.

This paper reports the consensus of an international faculty of expert metal-on-metal (MoM) hip resurfacing surgeons, with a combined experience of over 40,000 cases, on the current status of hip resurfacing arthroplasty. Indications, design and metallurgy issues, release of metal ions and adverse soft tissue reactions to particles, management of problematic cases and revisions, as well as required experience and training are covered. The overall consensus is that MoM hip resurfacing should not be banned and should be viewed separately from MoM total hip arthroplasty (THA) with a large diameter head because of the different design and wear behaviour related to the taper/trunnion connection. The use of hip resurfacing has decreased worldwide but specialist centres continue to advocate hip resurfacing in young and active male patients. Regarding age the general recommendation is to avoid hip resurfacing in men older than 65 and in women older than 55, depending on the patient activity and bone quality. Female gender is considered a relative contraindication. Most surgeons would not implant a MoM hip in women who would still like a child. Regardless of gender, there is a consensus not to perform hip resurfacing in case of a femoral head size smaller than 46 mm and in patients with renal insufficiency or with a known metal allergy. Regarding follow-up of hip resurfacing and detection of adverse local tissue reactions, metal ion measurements, MRI and ultrasound are advocated depending on the local expertise. The consensus is that hip resurfacing should be limited to high volume hip surgeons, who are experienced in hip resurfacing or trained to perform hip resurfacing in a specialist centre.

Belgium experience with metal-on-metal surface arthroplasty.

Hybrid metal-on-metal surface arthroplasty of the hip has recently been introduced, with a vast number of implants used in European countries including Belgium. This article presents results in 252 hips with a mean follow-up of 2.8 years. Using a tight press-fit with minimal cement mantle as the technique of femoral fixation, there have been only three failures. The main complications have been avascular necrosis of the femoral head and femoral neck fracture. In most cases, patients returned to a high functional level with no restrictions in their physical activity and were highly satisfied. Future refinements in surgical technique and instruments will make this procedure more accessible and reproducible for the surgeon.

Kinetics of disappearance of resistance mutations and reappearance of wild-type during structured treatment interruptions.

OBJECTIVE: To monitor the disappearance of resistance-associated mutations and reappearance of wild-type (WT) virus during structured treatment interruptions (STI) using DNA sequencing and line probe assay. METHODS: Eleven HIV-1-infected patients participating in the MUTAVIR study undergoing a 3-month STI after multi-HAART failure were monitored biweekly. Genotypes were assessed by sequencing and VERSANT HIV-1 Resistance Assays (LiPA). RESULTS: At treatment interruption, 54 mutations in total were identified with both methods among the patients. LiPA provided a result for 93.3% of the codons at baseline. For 37 mutations, a complete reversion of mutant to WT was observed with one of the two methods. Among these, LiPA detected mutations in 23 codons for 7 to 52 days longer, in 10 codons for the same period, and in four codons for a shorter time than sequencing. Similarly, LiPA detected 35 WT codons 8 to 86 days earlier, and 15 at the same time point as sequencing. A sharp reduction in the number of mutations was observed at the time of viral load increase in five of the 11 patients. Taking only the codons detected by LiPA into consideration, two patients showed a complete reversion to WT according to both genotyping assays at the end of the STI period. CONCLUSIONS: The determination of the timepoint at which a virus population of an HIV-1 patient undergoing STI reverts to WT is dependent on the assay used. The viral load increase in most patients is compatible with the outgrowth of virus with fewer or no mutations.

A combination of poor adherence and a low baseline susceptibility score is highly predictive for HAART failure.

The relationship between adherence, virological response to highly active antiretroviral therapy (HAART) and the presence and development of genotypic resistance was assessed in 41 HIV-infected patients on HAART. Four adherence parameters (drug taking adherence, dosing adherence, timing adherence and drug holidays) were scored prospectively using electronic event monitoring. Genotypic resistance at baseline and after therapy failure was scored retrospectively and a genotype-based susceptibility score was calculated. Overall median adherence rates were high. All adherence parameters were better in virological responders (n=31) compared to non-responders (n=10), drug taking adherence and number of drug holidays being significantly different. Responders had a significantly higher susceptibility score. Stepwise logistic regression showed that the number of drug holidays and a low susceptibility score were highly predictive for therapy failure. Despite the presence of a limited number of baseline resistance mutations, perfectly adherent patients can control virus replication for a prolonged period.

Increased case finding of tuberculosis from sputum and sputum deposits after magnetic bead concentration of mycobacteria.

Concentration of mycobacteria from sputum by centrifugation prior to acid-fast microscopy increases case finding compared to direct microscopy of the sputum (direct smear). However, centrifugation has to be performed outside the safety cabinet and many laboratories do not have access to a centrifuge. Magnetic bead extraction of the mycobacteria is an alternative method that can be performed in a cabinet with just a magnet. Magnetic TB-Bead (Microsens Medtech Ltd) extraction of mycobacteria from sputum prior to microscopy was compared to direct smear on 78 sputum samples. Microscopy of the TB-Bead extracts identified all of 26 of the direct smear positive samples either with the same microscopy score or, in 19/27 of samples, with an increased microscopy score which aided microscopy detection. In addition, microscopy of the TB-Bead extracts identified 10 additional positive samples compared to direct smear; which represents a statistically significant increase in case finding of 38% (p = 0.002) compared to direct smear. In a separate study, TB-Beads enabled further 4 positive samples to be detected from 30 centrifuged pellets that were originally smear negative; two of these were subsequently found to be positive when the original deposits were reinvestigated by smear microscopy. By concentrating mycobacteria from sputum and sputum deposits, TB-Beads have been demonstrated to increase the number of positive sputum samples which could increase case-finding. The TB-Bead method is simple and rapid and compatible with use within a safety cabinet.

Reducing metal ion release following hip resurfacing arthroplasty.

Recent guidelines have suggested that routine postoperative care of patients with metal-on-metal hip prostheses should involve metal ion analysis. This study sought to investigate the relationship between bearing surface wear rates of metal components and serum metal ion analysis and also to quantify the incidence of excessive increases in serum metal ion concentrations post-hip resurfacing arthroplasty.

Revisions of metal-on-metal hip resurfacing: lessons learned and improved outcome.

This retrospective, consecutive case series of a single surgeon performed between 2001 and 2010 assesses the outcome following revision of metal-on-metal hip resurfacing arthroplasties (N = 113). Mean time to revision was 31 months (0-101) after primary hip resurfacing. Malpositioning of the components with associated wear-induced soft tissue fluid collections was the most frequent factor leading to failure of a hip resurfacing arthroplasty. The mid-term outcome of the revisions was satisfactory; complications occurred in 11 patients (9.7%). Six of these patients underwent a re-revision.