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Purpose Some data indicate that first-generation highly cross-linked polyethylene (HXLPE) can oxidise in vivo and is associated with reduced mechanical properties. To overcome these limitations, a natural anti-oxidant vitamin E has been added to HXLPE to preserve the mechanical properties and decrease oxidative degradation whilst conserving high wear resistance. We hypothesised that after a minimal three years of follow-up the use of vitamin E-blended HXLPE would result in lower radiographic wear when compared with ultra-high molecular weight polyethylene (UHMWPE). Methods One hundred patients were randomised to receive hybrid total hip arthroplasty (THA) using a monoblock cementless acetabular component made either of UHMWPE or vitamin E-blended HXLPE. All other parameters were identical in both groups. Complete follow-up was available for 74 of these patients. Femoral head penetration was measured using a validated computer-assisted method. Results The median creep measured 0.111 mm (range, −0.576 – +0.444 mm) in the vitamin E-blended group versus 0.170 mm (range, −0.861 – +0.884 mm) in the UHMWPE group (difference of medians, 0.059; p  = 0.046). The median steady state penetration rate was −0.008 mm/year (range, −0.88 – +0.64 mm/year) in the vitamin E-blended group versus 0.133 mm/year (range, −0.84 – +0.85 mm/year) in the UHMWPE group (difference of medians 0.141, p  = 0.043). Conclusions This study demonstrated that femoral head penetration was lower when using vitamin E-blended HXLPE when compared with UHMWPE, with a steady-state penetration rate far below the osteolysis threshold. Longer-term follow-up is needed to warrant whether wear reduction will generate less occurrence of osteolysis and aseptic loosening.

Introduction Stent migration is a significant clinical problem in palliation of malignant strictures in the esophagus and gastro-esophageal junction (GEJ). We have compared a newer design of a fully-covered stent to a widely used semi-covered stent using migration >20 mm as the primary outcome variable. Effects on dysphagia, quality of life (QoL) and re-intervention frequency were also investigated. Methods Patients with dysphagia due to non-curable esophagus/GEJ cancer were randomized to receive either a more recent design of a fully-covered stent (n = 48) or a conventional semi-covered stent (n = 47). Chest x-ray, dysphagia and QoL were studied at baseline, one week, four weeks and three months thereafter. Results There were no significant differences either in stent migration distance or in the migration frequency. Stent migration during the total study period occurred in 37.2 % in the semi-covered group compared to 20.0 % for the fully-covered group. Dysphagia was measured with Watson and Ogilvie scores and with the dysphagia module in the QoL scale (QLQ-OG25). On average, there was a tendency to better dysphagia relief for the fully-covered design as scored with the two latter dysphagia instruments (p= 0.081 and p= 0.067) at three months and towards more re-interventions in the semi-covered group (p= 0.083). Conclusion In spite of its somewhat lower intrinsic radial force, the fully-covered stent was comparable to the conventional semi-covered stent with regard to stent migration. The data further suggest a potential benefit of the fully-covered stent in improving dysphagia in patients with longer life expectancy.

Background Inferior placement of a femoral stem is predictive for early loosening and failure, but does restoration of the original hip anatomy benefit the function and survival of a total hip replacement? Methods Seventy-five patients with primary unilateral hip osteoarthritis operated with an uncemented anatomical stem were randomized for either standard or modular stems. We used 50 ABG II stems with modular necks and 25 standard stems (control group). We measured the symmetry in hip anatomy between healthy and operated side. The anatomical restoration variables were anteversion, global offset, and femoral offset/acetabular offset (FO/AO) quota. We performed measurements using a CT-based 3D templating and measuring software. Migratory behavior of the stems was then measured postoperatively with repeated radiostereometry (RSA) examinations over 5 years. Results Both stem types showed an early (within 3 months) good stabilization after an initial slight rotation into retroversion and subsidence. There were no significant differences in RSA migration between modular and standard stems. Postoperative anteversion and FO/AO quota had no impact on stem migration. The standard stem tended to result in insufficient global offset (GO), whereas the modular stem did not. Conclusions The modular stem gave good symmetrical anatomical restoration and, like the standard version, a benign migratory behavior. Anteversion, GO, and FO/AO quota had no significant impact on stem migration. It therefore seems to be of no importance whether we choose a modular or a standard stem with regard to postoperative stem migration for this stem type. We overestimated the effect anatomical parameters have on stem movement; hence, we believe the study to be underpowered. Trial registration ClinicalTrials.gov identifier: NCT01512550 . Registered 19 January 2012—retrospectively registered,

This study aimed to assess differences in the fixation and functional outcomes between pegged and keeled all-polyethylene glenoid components for standard total shoulder arthroplasty. Patients were randomized to receive a keeled or pegged all-polyethylene glenoid component. We used model-based radiostereometric analysis (RSA) to assess glenoid fixation and subjective outcome measures to assess patient function. Follow-up examinations were completed at 6 weeks and 6, 12 and 24 months after surgery. Modifications to the RSA surgical, imaging and analytical techniques were required throughout the study to improve the viability of the data. Stymied enrolment resulted in only 16 patients being included in our analyses. The RSA data indicated statistically greater coronal plane migration in the keeled glenoid group than in the pegged group at 12 and 24 months. Functional outcome scores did not differ significantly between the groups at any follow-up. One patient with a keeled glenoid showed high component migration after 24 months and subsequently required revision surgery 7 years postoperatively. Despite a small sample size, we found significant differences in migration between glenoid device designs. Although clinically these findings are not robust, we have shown the feasibility of RSA in total shoulder arthroplasty as well as the value of a high-precision metric to achieve objective results in a small group of patients. Cette étude avait pour objet d’évaluer les différences sur le plan de la fixation et des résultats fonctionnels entre les composants glénoïdiens à plots et à quille, tous deux en polyéthylène, dans une arthroplastie totale traditionnelle de l’épaule. La répartition des composants glénoïdiens en polyéthylène à plots et à quille a été faite de façon aléatoire. Nous nous sommes servis de modèles d’analyses radiostéréométriques (ARS) pour évaluer la fixation glénoïdienne et les indicateurs de résultats subjectifs, ce qui nous a ainsi permis d’évaluer les résultats fonctionnels des patients. Quatre examens de suivi ont été réalisés après la chirurgie : à 6 semaines, puis à 6 mois, à 12 mois et à 24 mois. Tout au long de l’étude, des ajustements ont été apportés aux modèles d’ARS de la chirurgie, de l’imagerie et des analyses afin d’améliorer la viabilité des données. Des problèmes liés au recrutement ont fait en sorte que nous n’avons retenu que 16 patients dans le cadre de nos analyses. Les données d’ARS ont montré une migration statistiquement plus grande du plan frontal dans le groupe quille que dans le groupe plots à 12 et à 24 mois. Les résultats fonctionnels étaient sensiblement les mêmes d’un groupe à l’autre, peu importe le moment du suivi. Un patient du groupe quille a présenté une migration très importante du composant après 24 mois; il a dû subir une chirurgie de révision 7 ans après la chirurgie initiale. Malgré la petite taille de l’échantillon, nous avons observé des différences significatives dans la migration des composants, selon le type utilisé. Même si ces observations ne permettent pas d’arriver à des conclusions robustes d’un point de vue clinique, nous avons montré qu’il est possible d’avoir recours aux ARS en contexte d’arthroplastie totale de l’épaule et démontré la valeur associée à l’utilisation de mesures de haute précision pour l’obtention de résultats objectifs chez un petit groupe de patients.

BackgroundProtocols including combination of surgery and radiotherapy are more and more frequent in the treatment of bone tumors of the spine. In metastatic disease, combination of surgery and radiotherapy is since long time accepted, as based on clinical evidence. In primary tumors, combination of surgery and radiotherapy can be considered in all the cases in which a satisfactory oncological margin cannot be achieved: high-grade malignancies, recurrent tumors, huge tumors expanding in an extracompartimental area, and when tumor-free margin requires unacceptable functional sacrifices. However, metal implants are an obstacle in the collaboration between surgeons and radiation oncologists. Carbon-fiber-reinforced polyethil–ether–ether–ketone (CFR-PEEK) composite implants could make easier and more effective the treatment as radiolucent and not interfering with ionizing radiation and accelerated particles. The purpose of this article is to report the preliminary results from a cohort of patients treated with CFR-PEEK and to evaluate the safety and the non-inferiority of the device respect the commonly used titanium implants.Materials and methodsThis study concerns an ambispective cohort series of 34 tumor patients (14 metastases and 20 primaries, most of them recurrent) submitted to thoracic and lumbar spine fixation with a CFR-PEEK composite implants. Oncologic surgery was palliative decompression and fixation in 9 cases, tumor excision in 21, and enbloc resection in 4. Data collected for this preliminary report were all intraoperative remarks, incidence of complications, changes in neurological status, local control, and survival. All the cases were followed 6–36 months (mean 13 months).ResultsOnly one intraoperative screw breakage occurred out of 232 implanted screws. Pain control and neurological improvement were the early clinical results. Two sacral screws loosening were found at 9 and 12 months in multilevel constructs performed on multirecurrent tumors. Six local recurrences were early found thanks to the implant radiolucency. Radiation oncologists’ opinion was favourable as concerning better treatment planning on CT and lacking of scattering effect during the treatment.ConclusionsNo artifacts on imaging studies mean early local recurrence detection. For radiation oncologists, no artifacts on imaging studies mean easier planning and no scattering effect means more effective and safe radiotherapy, particularly when particles are used. Moreover, it seems that the clinical use of CFR-PEEK composite implants may be safe and at least comparable with the commonly used titanium implants in terms of intraoperative complications, stability at weight bearing and at functional recovery. Larger patient series and longer follow-up are required to confirm these data.

Key Points Ureteral stents are associated with complications including infection, encrustation, haematuria and discomfort that can be caused by tissue irritation The role of bacterial adhesion and biofilm formation on stents in stent-associated UTIs is unclear and development of UTIs and their treatment might depend on patient immune status Encrustation and calcification are common problems that can lead to severe complications, which can be prevented by implementing electronic systems to monitor stent dwell times Metal stents are a good alternative to polymer stents in the treatment of extrinsically caused ureteral obstruction; flexible and drug-eluting metal designs could help ameliorate discomfort and stenosis, respectively Biodegradable ureteral stents could avoid complications, such as encrustation, but flaws in their biocompatibility still need to be addressed Future stent design will focus on biodegradable and metal stents that elute drugs to prevent complications and are engineered to treat specific urological conditions In this Review, Lange et al . give an overview of the main complications associated with commonly used ureteral stents and discuss novel stent designs based on metal or biodegradable materials that could help ameliorate patient discomfort and overcome current problems, such as encrustation and stenosis. Ureteral stents are one of the most commonly used devices in the treatment of benign and malignant urological diseases. However, they are associated with common complications including encrustation, infection, pain and discomfort caused by ureteral tissue irritation and possibly irregular peristalsis. In addition, stent migration and failure due to external compression by malignancies or restenosis occur, albeit less frequently. As these complications restrict optimal stent function, including maintenance of adequate urine drainage and alleviation of hydronephrosis, novel stent materials and designs are required. In recent years, progress has been made in the development of drug-eluting expandable metal stents and biodegradable stents. New engineering technologies are being investigated to provide stents with increased biocompatibility, decreased susceptibility to encrustation and improved drug-elution characteristics. These novel stent characteristics might help eliminate some of the common complications associated with ureteral stenting and will be an important step towards understanding the behaviour of stents within the urinary tract.

Implant survival after conventional total hip replacement (THR) is often poor in younger patients, so alternatives such as hip resurfacing, with various sizes to fit over the femoral head, have been explored. We assessed the survival of different sizes of metal-on-metal resurfacing in men and women, and compared this survival with those for conventional stemmed THRs. We analysed the National Joint Registry for England and Wales (NJR) for primary THRs undertaken between 2003 and 2011. Our analysis involved multivariable flexible parametric survival models to estimate the covariate-adjusted cumulative incidence of revision adjusting for the competing risk of death. The registry included 434 560 primary THRs, of which 31 932 were resurfacings. In women, resurfacing resulted in worse implant survival than did conventional THR irrespective of head size. Predicted 5-year revision rates in 55-year-old women were 8·3% (95% CI 7·2–9·7) with a 42 mm resurfacing head, 6·1% (5·3–7·0) with a 46 mm resurfacing head, and 1·5% (0·8–2·6) with a 28 mm cemented metal-on-polyethylene stemmed THR. In men with smaller femoral heads, resurfacing resulted in poor implant survival. Predicted 5-year revision rates in 55-year-old men were 4·1% (3·3–4·9) with a 46 mm resurfacing head, 2·6% (2·2–3·1) with a 54 mm resurfacing head, and 1·9% (1·5–2·4) with a 28 mm cemented metal-on-polyethylene stemmed THR. Of male resurfacing patients, only 23% (5085 of 22076) had head sizes of 54 mm or above. Hip resurfacing only resulted in similar implant survivorship to other surgical options in men with large femoral heads, and inferior implant survivorship in other patients, particularly women. We recommend that resurfacing is not undertaken in women and that preoperative measurement is used to assess suitability in men. Before further new implant technology is introduced we need to learn the lessons from resurfacing and metal-on-metal bearings. National Joint Registry for England and Wales.

This study was conducted to longitudinally compare a new floating platform mobile-bearing (MB) prosthesis with an established fixed-bearing (FB) system with respect to early clinical outcomes in patients with bilateral TKAs using the MB prosthesis in one knee and the FB prosthesis in the other. Clinical outcomes (ROM, AKS and WOMAC scores, and side preference), evaluated at 6, 12 and 24 months postoperatively, were compared between knees fitted with the MB prosthesis (e.motion-FP) or the FB prosthesis (Genesis II) in 66 patients who underwent bilateral TKA. In addition, the same comparisons between the knees fitted with the MB prosthesis and the knees with the FB prosthesis were made separately in the subgroup of 33 patients implanted with a cruciate retaining FB (FB-CR) prosthesis and the other subgroup of 33 patients with a posteriorly stabilized FB (FB-PS) prosthesis in a knee. The floating platform MB prosthesis achieved comparable clinical outcomes to the FB prosthesis. No significant differences were found between the FB- and MB-implanted sides at any time with respect to the outcome scales, and temporal patterns were similar. However, comparisons of FB-CR and FB-PS patient groups revealed different temporal patterns. In the FB-CR group, most outcome scales were improved at 6 months, peaked at 12 months and then remained at this level at 24 months. In contrast, outcomes in the FB-PS group improved much faster to almost peak at 6 months, and then remained at this level. In the FB-CR group, more patients preferred the knee with fitted with a MB prosthesis at 6 months. In contrast, in the FB-PS group, no side preference for the MB prosthesis was observed, and more patients preferred knees implanted with the FB prosthesis at 12 and 24 months. This study demonstrates that this new mobile-bearing prosthesis, designed as a floating platform, provides satisfactory clinical performances that are comparable to those achieved using the established fixed-bearing prosthesis in terms of clinical outcomes.

Purpose Despite numerous reconstructive techniques and prosthetic devices, pelvic reconstructions following peri-acetabular malignant tumours resections are highly challenging. In the present study, we describe our experience with the Integra® (Lépine, Genay, France) ice-cream cone prosthesis in such indications. The objective was to assess the mid-term outcomes of this device. Methods Twenty-four patients’ chart with peri-acetabular malignant tumours, who underwent types II or II + III peri-acetabular resections according to Enneking and Dunham with subsequent reconstruction using the Integra® prosthesis between February 2009 and February 2015, were reviewed. Seventeen cases were primary surgeries and seven cases were revisions (i.e., failures of previous reconstructions for pelvic tumours). All living patients with the prosthesis implanted were functionally assessed, using the musculoskeletal tumour society (MSTS) and Postel-Merle d’Aubigné (PMA) scores. Results After a mean follow-up of 49 ± 26 months (range, 8 to 94 months), 21 patients were alive (88%), including 15 patients continuously disease-free (63%). MSTS and PMA scores averaged 72 ± 13% (range, 43 to 87%) and 14.6 ± 2.6 (range, 9 to 18), respectively. Fourteen patients (58%) presented at least one complication during follow-up, including four cases of deep infection (17%), four cases of dislocation (17%), and two mechanical failures (8%). At 5 years, the implant survival rate was 75%. Conclusions In comparison to previous reconstructive techniques that we used in similar indications, functional and oncologic outcomes were improved with the Integra® implant. However, as commonly observed in pelvic bone tumour surgery, complication rates remain significant. Level of evidence Therapeutic, Level IV-Retrospective Cases Series

PurposePedicle screw loosening is a common and significant complication after posterior spinal instrumentation, particularly in osteoporosis. Radiolucent carbon fiber-reinforced polyetheretherketone (CF/PEEK) pedicle screws have been developed recently to overcome drawbacks of conventional metallic screws, such as metal-induced imaging artifacts and interference with postoperative radiotherapy. Beyond radiolucency, CF/PEEK may also be advantageous over standard titanium in terms of pedicle screw loosening due to its unique material properties. However, screw anchorage and loosening of CF/PEEK pedicle screws have not been evaluated yet. The aim of this biomechanical study therefore was to evaluate whether the use of this alternative nonmetallic pedicle screw material affects screw loosening. The hypotheses tested were that (1) nonmetallic CF/PEEK pedicle screws resist an equal or higher number of load cycles until loosening than standard titanium screws and that (2) PMMA cement augmentation further increases the number of load cycles until loosening of CF/PEEK screws.MethodsIn the first part of the study, left and right pedicles of ten cadaveric lumbar vertebrae (BMD 70.8 mg/cm3 ± 14.5) were randomly instrumented with either CF/PEEK or standard titanium pedicle screws. In the second part, left and right pedicles of ten vertebrae (BMD 56.3 mg/cm3 ± 15.8) were randomly instrumented with either PMMA-augmented or nonaugmented CF/PEEK pedicle screws. Each pedicle screw was subjected to cyclic cranio-caudal loading (initial load ranging from − 50 N to + 50 N) with stepwise increasing compressive loads (5 N every 100 cycles) until loosening or a maximum of 10,000 cycles. Angular screw motion (“screw toggling”) within the vertebra was measured with a 3D motion analysis system every 100 cycles and by stress fluoroscopy every 500 cycles.ResultsThe nonmetallic CF/PEEK pedicle screws resisted a similar number of load cycles until loosening as the contralateral standard titanium screws (3701 ± 1228 vs. 3751 ± 1614 load cycles, p = 0.89). PMMA cement augmentation of CF/PEEK pedicle screws furthermore significantly increased the mean number of load cycles until loosening by 1.63-fold (5100 ± 1933 in augmented vs. 3130 ± 2132 in nonaugmented CF/PEEK screws, p = 0.015). In addition, angular screw motion assessed by stress fluoroscopy was significantly smaller in augmented than in nonaugmented CF/PEEK screws before as well as after failure.ConclusionsUsing nonmetallic CF/PEEK instead of standard titanium as pedicle screw material did not affect screw loosening in the chosen test setup, whereas cement augmentation enhanced screw anchorage of CF/PEEK screws. While comparable to titanium screws in terms of screw loosening, radiolucent CF/PEEK pedicle screws offer the significant advantage of not interfering with postoperative imaging and radiotherapy.Graphical abstractThese slides can be retrieved under Electronic Supplementary Material.