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Objectives: This study aimed to characterize the processes of listing prostheses and medical devices in all insurance schemes., Methods: A literature review was performed, and in-depth interviews were conducted with the representatives of 6 insurance agencies. Civil Servant Medical Benefits Scheme (CSMBS), Social Security Scheme, Local Government Officer Scheme (LGOS), State Enterprise Scheme (SES), Universal Coverage Scheme (UCS), and Non-Thai Resident Scheme (NTRS)., Results: The outcomes of interest were structure details and the body of the working groups, listing processes, and key assessment criteria. Each insurance scheme's process can be summarized in 5 steps: (1) receiving the proposed topics of health technologies, (2) screening, (3) selection, (4) consideration, and (5) approval and publicization. Notably, the organizational structures and working group compositions vary across schemes, leading to differences in process activities and assessment criteria. LGOS and SES are exceptions because they follow the application process of CSMBS. UCS demonstrates the most transparent process, providing specific working groups that are competent in undertaking each activity. The processes of listing prostheses and medical devices vary across health insurance in Thailand, leading to varying numbers of health technologies covered by insurance schemes., Conclusions: This study characterizes prostheses and medical device listing processes in 6 Thai Universal Health Coverage insurance schemes (CSMBS, Social Security Scheme, UCS, LGOS, SES, and Non-Thai Resident Scheme). Variations in processes result in differing technology listings. It offers essential insights for healthcare professionals and policy makers., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section., (Copyright © 2024 International Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: Prosthetists and orthotists (POs) are essential members of the health care workforce and one of the United Kingdom's (UK's) allied health professions. There is a paucity of information on their demographics, which is essential for the development of the profession. To fill this void, this study has attempted to comprehensively explore the sociodemographics and work-related characteristics of the entire workforce., Methods: Data were collected in 2022 through multiple sources, including surveys of POs, private companies employing POs, and freedom of information requests to National Health Service Trusts/Health Boards and higher education institutes offering programs leading to registration as a prosthetist/orthotist., Results: The workforce survey had 641 respondents (74% response rate). The estimated national ratio of POs per million population was 13, with all bar of the 12 regions below the World Health Organization minimum recommendation of 15 POs per million population. Most of the survey respondents were female (47.6%) and younger than male respondents, were British (75.8%), and in the White ethnic group (74.3%). Most of them were employed by private companies (59.9% vs. 31.4% employed by the National Health Service) and had clinical duties (94%), permanent contracts (90%), worked full-time (75%), and treated a wide range of clinical conditions., Conclusions: The national UK prosthetist and orthotist ratio falls below the recommended international standards. The versatility and broad skill set of POs highlight their crucial role in multidisciplinary teams. Establishing a centralized prosthetist and orthotist workforce database system is recommended for data-driven strategic planning., (Copyright © 2024 International Society for Prosthetics and Orthotics.)

Objective: In a postlaryngectomy patient, tracheoesophageal (TE) speech is considered to be the most effective and preferred method of communication. Previous research has demonstrated that despite an appropriately sized TE prosthesis placement at the time of puncture, there are a portion of patients that require resizing postoperatively. The purpose of this study was to report on the variability of the tracheoesophageal prosthesis length., Study Design: Retrospective chart review., Setting: Tertiary care academic medical center., Methods: This was a retrospective chart review of 62 patients who underwent secondary tracheoesophageal puncture (TEP) at a tertiary care academic medical center from January 2008 to November 2019. Patient demographic information, average changes in prosthesis length, number of prosthesis adjustments, and timing of prosthesis exchanges were collected., Results: 62 patients met criteria for study inclusion. Mean age was 61.96 years old with 49 being male (79%) and 13 (21%) females. Overall change in prosthesis length was - 3.85 mm ± 3.58 with time to first prosthesis change at 2.29 months ± 2.73. There was an average of 4.37 changes ± 3.43 before reaching a stable length. Twenty-six patients (41.9%) had increases in their prosthesis length resulting in closure of the tracheoesophageal fistula requiring seven patients (11.3%) to return to the operating room for repuncturing. History of smoking (P = 0.02), Blom-Singer prosthesis type (P = 0.03), and larger diameter (P = 0.01) appeared to be predisposing factors for a fluctuating prosthesis length., Conclusion: Tracheoesophageal prosthesis length decreases over time for secondary punctures, requiring adjustments with a speech language pathologist. There are a clinically significant portion that have fluctuations in prosthesis length resulting in an increased risk for requiring re-puncturing., (Published by Elsevier Inc.)

This prospective clinical study aimed to evaluate the peri-implant hard tissue dimensional change at 6 months of immediate implant placement with bone graft materials in the posterior area using cone-beam computed tomography (CBCT). Twelve dental implants were placed concurrently following tooth extraction in the posterior area and filled with xenograft particles. The CBCT images were taken immediately after surgical procedures and then at 6 months follow-up. To evaluate the hard tissue changes, the vertical and horizontal bone thickness were analyzed and measured using ImageJ software. Paired t -test or Wilcoxon match-pair signed-rank test was done to analyze the changes of hard tissue values at the same level between immediately and 6 months following immediate implant placement. Independent t -test or Mann-Whitney U test was used to analyze the dimensional change in the vertical and horizontal direction in buccal and lingual aspects. The level of significance was set at p value = 0.05. All implants were successfully osseointegrated. At 6 months follow-up, the vertical bone change at the buccal aspect was -0.69 mm and at the lingual aspect -0.39 mm. For horizontal bone thickness, the bone dimensional changes at 0, 1, 5, and 9 mm levels from the implant platform were -0.62 mm, -0.70 mm, -0.24 mm, and -0.22 mm, respectively. A significant bone reduction was observed in all measurement levels during the 6 months after implant placement ( p value < 0.05). It was noted that even with bone grafting, a decrease in bone thickness was seen following the immediate implant placement. Therefore, this technique can be an alternative method to place the implant in the posterior area.

Significance: The intent of this work was to summarize the existing evidence of, and highlight knowledge gaps specific to, prosthetic devices/componentry and training regimes, particularly in the context of the human-device interaction and deleterious musculoskeletal conditions secondary to lower limb loss. Recent Advances: With the recent and evolving technological advancements in prostheses, there are numerous devices available to individuals with lower limb loss. Current literature demonstrates the importance of expanding the knowledge of all prosthetic device-specific factors and the significance of proper prescription, fit, and alignment, along with adequate device-/activity-specific training, to enhance human-device interaction, reduce gait abnormalities and compensatory motions, and as a result, mitigate risk for secondary musculoskeletal conditions. Critical Issues: Inadequate device prescription, fit, alignment, and training are evident owing to the lack of knowledge or awareness of the many device-specific properties and factors, leading to suboptimal use, as well as, biomechanical compensations, which collectively and adversely affect the function, activity level, and overall health of the prosthesis user. Future Directions: To maximize optimal outcomes after lower limb loss, it is essential to better appreciate the factors that affect both prosthesis use and satisfaction, particularly any modifiable factors that might be targeted in rehabilitation interventions such as device prescription, fit/alignment, and training regimes. A better understanding of such device-specific factors will help enhance the human-device interaction and resulting functional performance, thereby reducing secondary musculoskeletal conditions, allowing for the readiness of the fighting force (return-to-duty/redeployment) and/or improved reintegration into civilian society/work, and overall enhancing quality of life after lower limb loss.

Background: Prosthesis-related complications, after knee reconstruction with endoprosthesis during operation for tumors around the knee, remain an unresolved problem which necessitate a revision or even an amputational surgery. The purpose of the current study was to identify significant risk factors associated with implant failure, and establish a novel model to predict survival of the prosthesis in patients operated with endoprostheses for tumor around knee., Methods: We retrospectively reviewed the clinical database of our institution for patients who underwent knee reconstruction due to tumors. A total of 203 patients were included, including 123 males (60.6%) and 80 (39.4%) females, ranging in age from 14 to 77 years (mean: 34.3 ± 17.3 years). The cohort was randomly divided into training (n = 156) and validation (n = 47) samples. Univariable COX analysis was used for initially identifying potential independent predictors of prosthesis survival with the training group (p < 0.150). Multivariate COX proportional hazard model was selected to identify final significant prognostic factors. Using these significant predictors, a graphic nomogram, and an online dynamic nomogram were generated for predicting the prosthetic survival. C-index and calibration curve were used for evaluate the discrimination ability and accuracy of the novel model, both in the training and validation groups., Results: The 1-, 5-, and 10-year prosthetic survival rates were 94.0, 90.8, and 83.0% in training sample, and 96.7, 85.8, and 76.9% in validation sample, respectively. Anatomic sites, length of resection and length of prosthetic stem were independently associated with the prosthetic failure according to multivariate COX regression model (p<0.05). Using these three significant predictors, a graphical nomogram and an online dynamic nomogram model were generated. The C-indexes in training and validation groups were 0.717 and 0.726 respectively, demonstrating favourable discrimination ability of the novel model. And the calibration curve at each time point showed favorable consistency between the predicted and actual survival rates in training and validation samples., Conclusions: The length of resection, anatomical location of tumor, and length of prosthetic stem were significantly associated with prosthetic survival in patients operated for tumor around knee. A user-friendly novel online model model, with favorable discrimination ability and accuracy, was generated to help surgeons predict the survival of the prosthesis., (© 2021. The Author(s).)

Wireless, battery-free, and fully subdermally implantable optogenetic tools are poised to transform neurobiological research in freely moving animals. Current-generation wireless devices are sufficiently small, thin, and light for subdermal implantation, offering some advantages over tethered methods for naturalistic behavior. Yet current devices using wireless power delivery require invasive stimulus delivery, penetrating the skull and disrupting the blood-brain barrier. This can cause tissue displacement, neuronal damage, and scarring. Power delivery constraints also sharply curtail operational arena size. Here, we implement highly miniaturized, capacitive power storage on the platform of wireless subdermal implants. With approaches to digitally manage power delivery to optoelectronic components, we enable two classes of applications: transcranial optogenetic activation millimeters into the brain (validated using motor cortex stimulation to induce turning behaviors) and wireless optogenetics in arenas of more than 1 m 2 in size. This methodology allows for previously impossible behavioral experiments leveraging the modern optogenetic toolkit., Competing Interests: The authors declare no competing interest.

Background: To report the 3-year results of a prospective, single arm, multicenter, international clinical study with the second generation of the temporary implantable nitinol device (iTIND; Medi-Tate Ltd®, Israel) on men suffering lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO)., Methods: Eighty-one men with symptomatic BPO (IPSS ≥ 10, peak urinary flow <12 ml/s, and prostate volume <75 ml) were enrolled in this study between December 2014 and December 2016. Subjects were washed-out 1 month for alpha-blockers and 6 months for 5-ARIs. The implantation was performed under light sedation and the removal 5-7 days later with topical anesthesia. Perioperative results including OR-time, pain (VAS) postoperative complications (Clavien-Dindo-Grading System), functional results (Qmax, IPSS, PVR) and quality of life (QoL) were assessed at 1, 3, 6 months, 1, 2, and 3 years. Sexual and ejaculatory function were evaluated using two yes/no questions., Results: Thirty-six month functional results were available for 50 patients and demonstrated that iTIND efficacy remained stable through 3 years, with averages IPSS, QOL, Qmax and PVR of 8.55 + 6.38, 1.76 + 1.32, 15.2 + 6.59 ml/s and 9.38 + 17.4 ml, improved from baseline by -58.2, -55.6, +114.7, and -85.4% (all significantly different from their corresponding baseline values, p < 0.0001). Even considering the Intention to Treat analysis (ITT), the 36-month results confirmed significant improvements of the functional outcomes if compared with baselines values (all p < 0.0001). No late post-operative complications were observed between 12 and 36 months. Sexual function was stable through 3 years, with no reports of sexual or ejaculatory dysfunctions. No patients underwent alternative treatments between 24 and 36 months., Conclusion: Treatment of BPO-related LUTS with iTIND demonstrated a significant and durable reduction in symptoms and improvement of functional parameters and quality of life at 3 years of follow-up. No late post-operative complications, ejaculatory dysfunction or additional treatment failures were observed between 24 and 36 months.

Palatal defects are rehabilitated by fabricating maxillofacial prostheses called obturators. The treatment incorporates taking deviously unpredictable impressions to facsimile the palatal defects into plaster casts for obturator fabrication in the dental laboratory. The casts are then digitally stored using expensive hardware to prevent physical damage or data loss and, when required, future obturators are digitally designed, and 3D printed. Our objective was to construct and validate an economic in-house smartphone-integrated stereophotogrammetry (SPINS) 3D scanner and to evaluate its accuracy in designing prosthetics using open source/free (OS/F) digital pipeline. Palatal defect models were scanned using SPINS and its accuracy was compared against the standard laser scanner for virtual area and volumetric parameters. SPINS derived 3D models were then used to design obturators by using (OS/F) software. The resultant obturators were virtually compared against standard medical software designs. There were no significant differences in any of the virtual parameters when evaluating the accuracy of both SPINS, as well as OS/F derived obturators. However, limitations in the design process resulted in minimal dissimilarities. With further improvements, SPINS based prosthetic rehabilitation could create a viable, low cost method for rural and developing health services to embrace maxillofacial record keeping and digitised prosthetic rehabilitation.

Background: Anal inserts and percutaneous tibial nerve stimulation may be offered to those with fecal incontinence in whom other conservative treatments have failed., Objective: We aimed to compare anal inserts and percutaneous tibial nerve stimulation., Design: This was an investigator-blinded randomized pilot study., Settings: The study was conducted at a large tertiary care hospital., Patients: Adult patients with passive or mixed fecal incontinence were recruited., Interventions: Patients were randomly assigned to receive either the anal inserts or weekly percutaneous tibial nerve stimulation for a period of 3 months., Main Outcome Measures: The primary end point was a 50% reduction of episodes of fecal incontinence per week as calculated by a prospectively completed 2-week bowel diary. Secondary end points were St Mark's incontinence score, International Consultation on Incontinence Questionnaire-Bowel scores (for bowel pattern, bowel control, and quality of life), use of antidiarrheal agents, estimates of comfort and acceptability., Results: Fifty patients were recruited: 25 were randomly assigned to anal inserts and 25 were randomly assigned to percutaneous tibial nerve stimulation. All completed treatment. A significant improvement of scores in the 2-week bowel diary, the St Mark's scores and the International Consultation on Incontinence Questionnaire-Bowel scores, was seen in both groups after 3 months of treatment. A reduction of ≥50% fecal incontinence episodes was reached by 76% (n = 19/25) by the anal insert group, compared with 48% (n = 12/25) of those in the percutaneous tibial nerve stimulation group (p = 0.04). The St Mark's fecal incontinence scores and the International Consultation on Incontinence Questionnaire-Bowel scores for bowel pattern, bowel control, and quality of life (p = 0.01) suggest similar improvement for each group., Limitations: A realistic sample size calculation could not be performed because of the paucity of objective prospective studies assessing the effect of the insert device and percutaneous tibial nerve stimulation., Conclusions: Both anal insert and percutaneous tibial nerve stimulation improved the symptoms of fecal incontinence after 3 months of treatment. The insert device appeared to be more effective than percutaneous tibial nerve stimulation. Larger studies are needed to investigate this further. See Video Abstract at http://links.lww.com/DCR/B460., Trial Registration Number: Clinicaltrials.gov No. NCT04273009., Estudio Piloto Aleatorizado De Inserciones Anales Contra La Estimulacin Percutnea Del Nervio Tibial En Pacientes Con Incontinencia Fecal: ANTECEDENTES:Las inserciones anales y la estimulación percutánea del nervio tibial (PTNS) se pueden ofrecer a las personas con incontinencia fecal que han fallado en otros tratamientos conservadores.OBJETIVO:Nuestro objetivo fue comparar inserciones anales y estimulación percutánea del nervio tibial.DISEÑO:Este fue un estudio piloto aleatorio ciego para investigadores.AJUSTE:El estudio se realizó en un hospital de atención terciaria.PACIENTES:Se reclutaron pacientes adultos con incontinencia fecal pasiva o mixta.INTERVENCIONES:Los pacientes fueron asignados al azar para recibir inserciones anales o estimulación del nervio tibial percutáneo semanal durante un período de tres meses.PRINCIPALES MEDIDAS DE RESULTADO:El principal resultado fue una reducción del 50% de los episodios de incontinencia fecal por semana, según lo calculado mediante un diario intestinal de dos semanas completado de forma prospectiva. Los criterios de valoración secundarios fueron la puntuación de incontinencia de St Mark, las puntuaciones del ICIQ-B (para patrón intestinal, control intestinal y calidad de vida), uso de agentes antidiarreicos, estimaciones de comodidad y aceptabilidad.RESULTADOS:Se reclutaron 50 pacientes: 25 fueron asignados al azar a inserciones anales y 25 a PTNS. Todo el tratamiento completado. Se observó una mejora significativa de las puntuaciones en el diario intestinal de dos semanas, la puntuación de St Mark y la puntuación del ICIQ-B en ambos grupos después de 3 meses de tratamiento. Se alcanzó una reducción de ≥ 50% de los episodios de incontinencia fecal en un 76% (n = 19/25) en el grupo de inserción anal, en comparación con el 48% (n = 12/25) de los del grupo de estimulación percutánea del nervio tibial (p = 0,04). Las puntuaciones de incontinencia fecal de St Mark, las puntuaciones del ICIQ-B para el patrón intestinal, el control intestinal y la calidad de vida (p = 0,01) sugieren una mejora similar para cada grupo.LIMITACIONES:No se pudo realizar un cálculo realista del tamaño de la muestra debido a la escasez de estudios prospectivos objetivos que evaluaran el efecto del dispositivo de inserción y la estimulación percutánea del nervio tibial.CONCLUSIONES:Tanto la inserción anal como la estimulación percutánea del nervio tibial mejoraron los síntomas de incontinencia fecal después de 3 meses de tratamiento. El dispositivo de inserción parecia ser más efectivo que la estimulación percutánea del nervio tibial. Se necesitan estudios más amplios para investigar esto más a fondo. Consulte Video Resumen en http://links.lww.com/DCR/B460.NÚMERO DE REGISTRO DE PRUEBA:Clinicaltrials.gov No. NCT04273009., (Copyright © The ASCRS 2021.)

Purpose: While limb-sparing surgery is now possible for more than 80% of patients with bone tumours, wide resection is often required, necessitating bone reconstruction. This paper aims to present a surgical technique that combines the advantages of a hollow, titanium, custom-made prosthesis and the biological aspects of microsurgical flaps and bone graft., Patients and Methods: From June 2016 to September 2017 at our institution, six consecutive patients with skeletal tumours underwent one-stage reconstructive surgery with concomitant implantation of a 3D-printed prosthesis., Results: At an average follow-up of 30 months (range: 18-45), no early complications were observed, and no implant removals were needed. One patient experienced a delayed haematogenous deep infection, which healed after surgical debridement. Three patients died of their underlying disease 18, 22, and 23 months after surgery, respectively. All flaps and custom reconstructions were successful, with primary osseointegration at a mean of four months (range: 2-7). Patients' average Musculoskeletal Tumour Society score was 23.2 (range: 18-28)., Conclusion: A hollow, custom-made, titanium prosthesis filled with bone graft, used in conjunction with a microsurgical flap, may offer good osseointegration in different anatomic locations among a patient population with a high risk of infection, pseudarthrosis, and long-term mechanical complications. The surgical technique's advantages are preliminarily demonstrated. Further studies with longer follow-up periods and larger sample sizes are required to confirm our findings., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: There are few reports on the surgical management of early-onset scoliosis (EOS) associated with Marfan syndrome (MFS). Affected patients tend to have more rapid curve progression than those with idiopathic EOS, and their course is further complicated by medical comorbidities. As surgical techniques and implants for growing spines become more widely applied, this study seeks to better delineate the safety and efficacy of growth-friendly spinal instrumentation in treating this population., Methods: A prospective registry of children treated for EOS was queried for MFS patients treated between 1996 and 2016. Forty-two patients underwent rib-based or spine-based growing instrumentation and were assessed on preoperative, surgical, and postoperative clinical and radiographic parameters including complications and reoperations. Subgroup analysis was performed based on spine-based versus rib-based fixation., Results: Patients underwent their index surgery at a mean age of 5.5 years, when the major coronal curve and kyphosis measured 77 and 50 degrees, respectively. Over half were treated with traditional growing rods. Patients underwent 7.2 total surgical procedures-4.7 lengthening and 1.9 revision surgeries not including conversion to fusion-over a follow-up of 6.5 (±4.1) years. Radiographic correction was greatest at index surgery but maintained over time, with a final thoracic height measuring 23.8 cm. Patients experienced a mean of 2.6 complications over the course of the study period; however, a small group of 6 patients experienced ≥6 complications while over half of patients experienced 0 or 1. Implant failures represented 42% of all complications with infection and pulmonary complications following., Conclusions: This is the largest report on patients with EOS and MFS. All subtypes of growth-friendly constructs reduced curve progression in this cohort, but complications and reoperations were nearly universal; patients were particularly plagued by implant failure and migration. Further collaborations are needed to enhance understanding of optimal timing and fixation constructs for those with MFS and other connective tissue diseases., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To undertake a prospective multicentre national audit of penile prosthesis practice in the UK over a 3-year period., Patients and Methods: Data were submitted by urological surgeons as part of the British Association of Urological Surgeons Penile Prosthesis National Audit. Patients receiving a penile prosthesis (inflatable or malleable) were included as part of a prospective registry over a 3-year period. Data were validated and then analysed using a software package (Tableau)., Results: A total of 1071 penile prosthesis procedures were included from 22 centres. The three commonest aetiological factors for erectile dysfunction were diabetes, prostate surgery and Peyronie's disease. Of the recorded data, inflatable penile prostheses were the commonest devices implanted, with 665 devices used (62.1%), whereas malleable prostheses accounted for 14.2% of the implants. Recorded intra-operative complications included urethral injury (0.7%, n = 7), corporal perforation (1.1%, n = 12) and cross-over (0.6%, n = 6). Known postoperative complications were recorded in 9.8% of patients (74/752), with the two most frequently reported being postoperative penile pain (n = 11) and scrotal haematoma (n = 14)., Conclusion: This baseline analysis is the largest prospective registry of penile prostheses procedures to date. The data show that, over the 3-year collection period in the UK, there are now fewer surgeons performing the procedure, together with a reduction in the number of centres. Peri-operative complications were infrequent, and the rate of implant abortion (e.g. as a result of urethral injury) was very low. Further follow-up data will be required to publish long-term outcomes and patient satisfaction., (© 2020 The Authors BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)

Objective: This study aimed to evaluate surgical and functional outcomes, in a tertiary referral centre, of two different types of semi-implantable transcutaneous bone conduction devices., Method: This study involved prospective data collection and review of patients implanted between November 2014 and December 2016. Glasgow Hearing Aid Inventory (Glasgow Hearing Aid Benefit Profile or Glasgow Hearing Aid Difference Profile) and Client Oriented Scale of Improvement were completed where appropriate. Surgical and audiological outcomes were recorded in the surgical notes., Results: Glasgow Hearing Aid Difference Profile and Glasgow Hearing Aid Benefit Profile showed similar mean score in the active and the passive transcutaneous bone conduction devices. Client Oriented Scale of Improvement showed improvements in listening situations. Post-operative speech reception threshold showed better mean threshold in the active transcutaneous bone conduction devices group when compared with the passive transcutaneous bone conduction devices group. No device failures or surgical complications existed in either group, with the surgical time being less in the passive transcutaneous bone conduction devices group., Conclusion: Both devices are reliable semi-implantable transcutaneous bone conduction devices with excellent surgical and functional outcomes and patient satisfaction. Overall surgical time was much less in the passive transcutaneous bone conduction devices group with no necessity for pre-planning. This is much easier to remove with the possibility of conversion to other devices in the manufacturer's portfolio and wide-ranging wireless accessories. Further studies are needed to assess the longer-term results in a bigger population.

Purpose: Biofilm-active antibiotics are suggested to improve the outcome of implant-associated infections; however, their role in infections after spinal instrumentation is unclear. Therefore, we evaluated the outcome of patients with spinal implant-associated infections treated with and without biofilm-active antibiotics., Methods: The probability of infection-free survival was estimated for treatment of spinal implant-associated infections with and without biofilm-active antibiotics using the Kaplan-Meier method; Cox proportional-hazards regression model was used to identify factors associated with treatment failure., Results: Among 93 included patients, early-onset infection was diagnosed in 61 (66%) and late-onset in 32 infections (34%). Thirty patients (32%) were treated with biofilm-active antibiotic therapy and 63 (68%) without it. The infection-free survival after a median follow-up of 53.7 months (range, 8 days-9.4 years) was 67% (95% confidence interval [CI], 55-82%) after 1 year and 58% (95% CI 43-71%) after 2 years. The infection-free survival after 1 and 2 years was 94% (95% CI 85-99%) and 84% (95% CI 71-93%) for patients treated with biofilm-active antibiotics, respectively, and 57% (95% CI 39-80%) and 49% (95% CI 28-61%) for those treated without biofilm-active antibiotics, respectively (p = 0.009). Treatment with biofilm-active antibiotics (hazard ratio [HR], 0.23, 95% CI 0.07-0.77), infection with Staphylococcus auras (HR, 2.19, 95% CI 1.04-4.62) and polymicrobial infection (HR, 2.44, 95% CI 1.09-6.04) were significantly associated with treatment outcome. Severe pain was observed more often in patients without biofilm-active antibiotic therapy (49% vs. 18%, p = 0.027)., Conclusion: Treatment with biofilm-active antibiotics was associated with better treatment outcome and less postoperative pain intensity.

Study Design: Analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods., Objective: The aim of this study was to quantify the rate of locking pin breakage in explanted MAGEC rods and compare with the manufacturer's data., Summary of Background Data: On June 25, 2019, NuVasive released an Urgent Field Safety Notice stating that MAGEC rods manufactured before March 26, 2015 had a higher than expected locking pin breakage rate of 5%. For rods made on or after that date, no pin breakages had occurred., Methods: From our independent explant database of 139 explanted MAGEC rods supplied from 10 UK spinal centers (Belfast, Bristol, Birmingham, Edinburgh, Exeter, Leeds, Newcastle, Nottingham, Oxford, and Sheffield) and one Danish center (Aarhus), we divided the rods into those manufactured before March 26, 2015, and those manufactured on or after that date. MAGEC rods were cut open to fully assess internal components including locking pins. From each of the two cohorts, 10 locking pins were selected at random and their diameters were measured using a micrometer., Results: One hundred and five explanted MAGEC rods were made before March 26, 2015 and could be disassembled to allow the locking pin to be examined. Fifty-nine percent (62/105) of these locking pins had fractured. For the MAGEC rods manufactured on or after March 26, 2015, 21% (6/29) were found to have fractured locking pins. Locking pins in MAGEC rods made on or after March 26, 2015 were of a stronger material and a larger diameter., Conclusion: Fifty-nine percent of the locking pins in MAGEC rods manufactured before March 26, 2015 had fractured, far greater than the 5% stated in the Urgent Field Safety Notice. Locking pin fracture still occurred in MAGEC rods manufactured on or after that date, in 21% of cases. This contrasted with the 0% reported by the manufacturer., Level of Evidence: 4.

Background: Detection of atrial fibrillation (AF) after cryptogenic stroke (CS) has therapeutic implications, but the most effective type and optimal duration of monitoring have still to be defined. This study that involved patients with CS or transient ischemic attack (TIA), all of whom carried an implantable cardiac monitor (ICM), sought to assess the incidence of AF and other arrhythmia detected using tele-monitoring or interval-based follow-up by an internal cardiologist at the university medical center of Rostock (UMR) or an external cardiologist., Methods: The ICM implantation was performed during the inpatient stay in the neurology department, with inclusion and exclusion criteria jointly determined by the neurology and cardiology departments. Cardiologists programmed individual threshold values during ICM implantation, which were designed to instantly trigger an episode being recording and an alarm message being sent out. Outpatient care consisted of tele-monitoring of implants or interval-based follow-up care., Results: The indication for ICM implantation was made for 102 patients, 88 of whom underwent ICM implantation, with full documentation available for these 88 study patients. Within a median observation period of 21.5 months, AF occurred in 19 patients, with a median observation time to the event of 7 months. In all cases, AF detection was followed by immediate medical intervention. Comparing patients with and without AF revealed that the median age of the AF group exceeded by 10 years that of the other patients. Stroke recurrence was recorded in five patients, with a median observation time to the event of 9 months. Comparing patients with and without stroke recurrence revealed that the median age in the stroke recurrence group tended to be higher by 14 years. No statistically significant between-group differences were found with regard to integration into tele-monitoring, nor were there any differences identified between outpatient care at the UMR or in the outpatient sector., Conclusions: This study confirmed the feasibility of using an interdisciplinary and intersectoral therapeutic approach for monitoring CS patients with implanted ICMs. Further randomized studies are warranted to confirm these encouraging data. An open discussion concerning optimal care forms and opportunities for introducing digitizing care pathways appears warranted.

Background and Objectives : Implant stability in vivo is contingent on multiple factors, such as bone structure, instrument positioning and implant surface modifications, implant diameter, and implant length. Resonance-frequency analysis is considered a non-invasive, reliable, predictable, and objective method by which to evaluate implant stability, due to its correlation with bone-to-implant contact. The purpose of this study was to evaluate the effect of implant length on the primary and secondary stability of single-implant crown rehabilitations, as measured by resonance-frequency analysis at different times. Materials and Methods : Implants of 10 and 11.5 mm were placed, and the resonance frequency was measured at the time of surgery (T0), as well as at 3 (T1), 6 (T2), and 12 (T3) months post-surgery. Results : A total of 559 implants were placed in 195 patients. Significant differences were observed when comparing the implant stability quotient (ISQ) values at T1, with values for 10-mm implants being greater than those for 11.5-mm implants ( p = 0.035). These differences were also observed when comparing ISQ values for buccal and lingual areas. At T0, T2, and T3, no significant differences in ISQ values were observed. The use of 10-mm implants in the anterior maxilla yielded significantly greater values at T0 ( p = 0.018) and T1 ( p = 0.031) when compared with 11.5-mm implants. Significant differences in measurements were observed only for buccal areas ( p = 0.005; p = 0.018). When comparing the sample lengths and sex, women with 11.5-mm implants showed significantly lower results than those with 10-mm implants ( p < 0.001). Conclusions : There is a direct relationship between implants of a smaller length and greater ISQ values, with this relationship being most evident in the maxilla and in women.

The US Food and Drug Administration's 2013 Unique Device Identification System Rule requires manufacturers to label devices with unique identifiers. Implantable devices are now shipped with unique identifiers, and many electronic health records have fields to incorporate them. Health policy changes have prompted hospital systems to assess implementation of implant barcode scanning systems to capture unique device identifiers. Project aims were to assess predictors of operating room nurses' acceptance of a new implant barcode scanning system, describe operating room nurses' perceptions of the system value, and identify operating room nurses' perceived gaps in system implementation. An online survey was disseminated to operating room nurses, and focus groups were conducted with orthopedic operating room nurses in an academic medical center that had recently implemented an implant barcode scanning system in surgical services. Predictors of barcode scanning acceptance included perceived usefulness for patient care, perceived ease of use, and perceived usefulness (self). Nurses perceived the system to be more accurate and valuable for patient safety. Perceived gaps in system implementation related to communication, completeness of the system, consistency in process, and training. Understanding nurse perceptions of new barcode scanning systems and engaging them in the implementation process are key areas for success and optimization of these systems.

Introduction: Implant wastage is an under-reported issue in orthopaedics, yet it has been shown to have a significant cost burden on healthcare budgets. In a background of a perilous financial climate in the UK health service, our aim was to define the frequency and costs of implant wastage in orthopaedic trauma., Materials and Methods: The trauma theatre's implant logbook was retrospectively analysed between April 2017 and April 2018. Wasted implants were identified by the study authors independently. Patient demographics, implant details and costs were among the data collected. Product codes of wasted implants were used to identify implant costs through the manufacturer., Results: Implant wastage occurred in 25.1% of trauma procedures during the study period. Most wasted implants (91%) were screws. The total cost of implant wastage was £8,377.25 during the 12-month period, accounting for 2% of the total implant budget. Wasted intramedullary nails accounted for almost 50% of the total cost. More than 51% of affected procedures involved a trainee as the primary operator., Discussion: We report the first study of implant wastage in orthopaedics from the UK. Total implant wastage was higher than reported in most of the published literature, although it represented a small portion of the budget. Implant wastage is attributable to surgeons or operating theatre staff in most cases and is compounded by surgeons' limited understanding of implant costs. Initiatives to reduce implant wastage should include raising awareness of costs and departmental wastage to surgeons and operating theatre staff as well as employing preoperative planning techniques.

Raynaud's phenomenon (RP) is a clinical disorder characterized by recurrent, reversible episodes of digital vasospasm. RP can be classified as primary (pRP) or secondary, depending on whether it occurs as a benign condition (not disease-associated) or is associated with other diseases, mainly of the connective tissues. In both cases, it can be triggered by environmental factors, as indicated by the increased incidence of pRP episodes following exposure to cold, vibration injury or chemicals. The purpose of this prospective case-control study was to assess, in an Italian cohort of 132 pRP patients, the association of the phenomenon with demographic, lifestyle habits, environmental and work-related factors. Compared to healthy controls, pRP was found to be inversely associated with the use of contact lenses (OR = 0.4; p = 0.004) and of chlorous-based disinfectants (OR = 0.3; p < 0.001) and directly associated with the presence of prosthesis implants (OR = 5.3; p = 0.001) and the use of hydrogen peroxide-based compounds (OR = 2.6; p = 0.002), suggesting that the latter should be avoided in RP affected patients. Multivariate and multivariable analysis confirmed the associations. Further investigations are needed to understand the mechanism(s) underlying these findings.

Purpose: To retrospectively analyze the entire cohort of patients in the Republic of Slovenia diagnosed with bone sarcomas in the long bones or pelvis/sacrum/coccyx from January 1, 2009, to December 31, 2018, with an observational nationwide study, whereby all patients were evaluated by one single tumor board in the country. We evaluated surgical outcomes and tested whether survival of bone sarcoma patients depended on age, gender, histological diagnosis., Materials and Methods: Cancer Registry of the Republic of Slovenia was screened for all ICD-10 diagnoses from C40.0 to C40.9 and C41.4 in the designated time frame, and the patients were then clinically followed up until the end of the observation period on June 1, 2019., Results: The cohort of 160 patients was treated surgically in 141 cases, 29 patients required subsequent revision(s) and cumulative endoprosthetic infection rate was 12.5%. In the follow-up, 54 patients died and the 2 patients were missing. Cumulative proportion of survival at 5/10 years was 61%/54%, respectively. After adjustment for age, gender and diagnosis, higher age (odds ratio 1.06 for each additional year), osteosarcoma (odds ratio 4.07) and Ewing sarcoma (odds ratio 11.68) were the significant risk factors of shorter oncological survival., Conclusion: This is the first Slovenian nationwide cohort study of bone sarcoma patients, unique in its circumscribed geographic area and evaluation/treatment at a single center by a single tumor board. Although comparable to other countries, results show a grim picture and the lack of improvement in bone sarcoma survival within the last 20 years.

Patients presenting with femoral fractures and long-term use of bisphosphonate treatment are at risk of developing a delayed union and/or nonunion as a result of the atypical metabolic activity prevailing at the fracture edges of the affected extremity. The treatment of these nonunions poses a serious challenge to orthopaedic surgeons worldwide and necessitates specialized techniques and materials to design a construct that will last a long period (greater than 6 months), while still allowing weight-bearing in this elderly population. Treatment options, timing of intervention, selection of implant, and the option of bone grafting are discussed to assist the clinician to make the right decisions in these complex clinical cases.

Objectives: This pilot study aimed to compare the commercial Unyvero ITI multiplex PCR application (U-ITI, Curetis GmbH) with conventional culturing concerning (a) detection of pathogens, (b) time to detection of pathogens and (c) time to and quality of antibiotic treatment recommendation in diagnostics of orthopedic implant-associated infections (OIAI)., Results: 72 tissue biopsies from 15 consecutive patients with deep OIAI infections were analyzed with conventional culturing including phenotypic antibiotic susceptibility testing and the U-ITI. U-ITI showed lower sensitivity than conventional culturing concerning detection of pathogens (73% vs 93%). 4/15 patients would have been given false negative results by U-ITI, all of which were culture-positive for Staphylococcus species. Median time to detection of pathogens was 47 h and antibiotic resistance 89 h by conventional methods compared to 13.5 h with the U-ITI. The U-ITI did not detect antibiotic resistance, whereas conventional culturing showed resistance to antibiotics covered by the U-ITI panel in 2 patients. Time to detection of pathogens was improved, but the detection limit for staphylococci was unsatisfactory. Although the time to antibiotic treatment recommendation was significantly reduced, the U-ITI would have resulted in incorrect antibiotic recommendation in 2 patients. Our data do not support use of this assay in diagnostics.

Background: This study determined the contributing factors of hospital sector (private versus public) variation in revision rates after elective total hip replacement (THR) for hip fracture, and elective total knee replacement (TKR)., Methods: Using data from a large national arthroplasty registry, funnel plots for hospitals were generated, displaying the proportion of revised primary procedures. The proportion of outliers for each distribution was defined as the proportion outside the upper 99.7% confidence limit. Survival analyses determined differences between hospital sector revision rates separately for implants with the lowest revision rate, and for all other implants. Multivariate Cox regression determined the role of hospital sector in revision, adjusting for possible confounders., Results: For THR performed for osteoarthritis, 17.4% of private and 4.4% of public hospitals were outliers. For TKR performed for osteoarthritis, 19.6% of private and 10.0% of public hospitals were outliers. For THR for fractured neck of femur, 8.1% of private and 0.0% of public hospitals were outliers. Adjusted and unadjusted Kaplan-Meier analyses showed higher THR revision rates in private hospitals for osteoarthritis and fractured neck of femur, but no difference when restricted to the 10 prostheses with the lowest revision rate. The Kaplan-Meier analysis of TKR showed higher revision rates for private hospitals, with the association reversing when restricted to prostheses with the lowest revision rate., Conclusions: Considerable variation was seen in the revision rate after THR and TKR between hospital sectors in Australia. The variation was largely due to differences in prosthesis selection., (© 2019 Royal Australasian College of Surgeons.)

Background/purpose: Prosthetic patch (patch) and muscle flap (flap) techniques are utilized for severe congenital diaphragmatic hernia (CDH) repair; however, when performed on extracorporeal membrane oxygenation (ECMO), the risk of hemorrhage increases. We sought to compare bleeding complications between repair types., Methods: We retrospectively reviewed 2010-2016 on-ECMO CDH repairs., Results: Twenty-nine patients met criteria: 13 patch (44.8%) and 16 flap (55.2%). Eight patch (61.5%) and 13 flap (81.2%) patients had left-sided defects (p = 0.223). All defects were Type C or D (Type C: patch 53.8%, flap 56.2%, p = 0.596). There was no difference in gestational age at delivery (patch 37.5 ± 0.9 weeks, flap 37.2 ± 1.3 weeks, p = 0.390) or age at repair (patch 7.46 ± 6.6 days, flap 6.00 ± 4.3 days, p = 0.476). Seven patch (53.8%) and 9 flap (56.2%) patients survived to discharge (p = 0.596). Estimated intraoperative blood loss was equivalent (patch 35.3 ± 53.9 mL, flap 24.2 ± 18.4 mL, p = 0.443). One patch patient (7.6%) and two (12.5%) flap patients required reoperation in the first 48 h for bleeding (p = 0.580). 48-h postoperative transfusions were the same for those that required reoperation (patch 282.0 mL/kg, flap 208.5 ± 21.9 mL/kg, p = 0.054) and those that did not (patch 120.7 ± 111.7 mL/kg, flap 118.4 ± 89.9 mL/kg, p = 0.561)., Conclusions: On-ECMO bleeding complications are equivalent for both flap and patch CDH repair., Level of Evidence: Type III (retrospective comparative study)., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Introduction: Medical school education on orthotics and prosthetics (O&P) is limited, and O&P students receive limited education on performing comprehensive histories and physicals (H&Ps). This interprofessional workshop brings medical and O&P students together in a mock clinical setting. Students from one profession appraise the relationship of their scope/role to those of students of the other profession., Methods: Third-year medical students, second-year O&P students, and O&P patients participated in a 3-hour workshop. Students partnered into groups and rotated among stations performing patient history, physical exam, and O&P assessment. As a medical or O&P student completed the H&P, she or he explained the process to the student of the other profession. Each group assessed two patients and then presented one to a physical medicine and rehabilitation (PM&R) attending physician. The workshop concluded with a feedback session., Results: Immediate feedback was positive. Medical students, O&P students, PM&R physicians, and patients all commented favorably. In the workshop's first year, there were 19 responding students (10 medical, nine O&P); 68.4% said that the clinical session was better than expected, 73.7% were satisfied with the overall event, and 73.7% felt they were likely to use what they had learned in clinical practice. Feedback from learners included requesting more time for students to interact with each other after the mock clinic, sending preparation materials before the session, and focusing the medical student H&P on the musculoskeletal exam., Discussion: This workshop was well received by participants. Their feedback will help to continue and expand this collaboration., Competing Interests: None to report., (Copyright © 2019 Misra et al.)

Objective: To assess morbidity and mortality following pelvic organ prolapse surgery in France, irrespective of the surgical technique, using a broad national database., Materials and Methods: This descriptive multicenter retrospective study was conducted using a database populated via an application run by a professional association., Results: 286 gynecologists contributed data to the database. Of the 4322 surgeries analyzed, an abdominal approach was used in 975 of cases (22.5%), a vaginal approach in 3277 (75.9%), and a combined approach in 68 (1.6%). After one year, abdominal surgery was associated with higher rates of de novo urinary incontinence, constipation, and intestinal obstruction, whereas vaginal surgery was associated with higher rates of urinary retention, hematoma, de novo chronic pain, and vaginal mesh extrusion. There was no significant difference between the groups in the incidence of severe complications. After one year, vaginal mesh-augmented cystocele repair was associated with higher rates of de novo urinary incontinence, de novo chronic pain, and reoperation than native tissue repair. Mesh repair was also associated with higher rates of severe complications at one year., Conclusion: After pelvic organ prolapse surgery, the perioperative morbidity and mortality associated with transabdominal and transvaginal approaches are similar. However, transvaginal mesh repair is associated with greater perioperative morbidity than transvaginal native tissue repair., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

A comprehensive description of the literature regarding interspinous process devices (IPD) mainly focused on comparison with conservative treatment and surgical decompression for the treatment of degenerative lumbar spinal stenosis. Recent meta-analysis and articles are listed in the present article in order to establish IPD pros and cons., Competing Interests: The authors declare no conflict of interest.

Orchiectomy is the standard of care for many testicular conditions. Testicular prosthesis placement (TPP) can mitigate psychosocial burden, restore self-image, and improve quality of life for patients requiring orchiectomy. Limited data exist regarding patient attitudes and counseling on TPP in the United States. The objective of this study was to characterize patient experiences after TPP, rationale for pursuing/declining TPP, and satisfaction levels. Patients with a history of urologic conditions warranting orchiectomy were identified and sent an anonymous survey addressing demographics, pre/post counseling, attitudes toward TPP, satisfaction rates, and postoperative complications. Sixteen percent (76/480) of patients completed the survey. Of these, 50.8% (32/63) undergoing orchiectomy were counseled by their surgeon about TPP, and 22.2% (14/63) received a prosthesis. The most common reasons for declining TPP included lack of concern for cosmetic appearance and lack of counseling. Leading reasons for pursuing TPP included improving self-confidence and cosmetic appearance. Although 71% (10/14) of patients were satisfied with TPP, they did highlight areas for improvement. Twenty percent (2/10) felt their implant was too high, 60% (6/10) felt their implant was too firm, 10% (1/10) endorsed discomfort during sex, and 30% (3/10) felt that TPP did not match their size expectations. Despite these findings, 71% (10/14) reported that they would have TPP again and 79% (11/14) would recommend TPP to others. TPP improves body image and quality of life following orchiectomy. Provider counseling plays an important role in influencing a patient's decision to undergo TPP. Areas of improvement include implant positioning and more effective replication of testicular consistency.

Study Design: A prospective, randomized multicenter IDE trial between May 2002 and October 2004., Objective: The aim of this study was to report on the 10-year safety and efficacy of BRYAN cervical disc arthroplasty (CDA)., Summary of Background Data: Cervical disc arthroplasty (CDA) is a potential alternative for anterior cervical decompression and fusion (ACDF) with the hope that maintenance of motion may decrease the likelihood of adjacent segment disease., Methods: This is an analysis of a US Food and Drug Administration (FDA) investigation comparing CDA with ACDF for single-level patients. Eligible patients were ≥ 21 years of age with symptomatic cervical disc disease who had failed conservative care. Patients were followed at regular intervals with the current data set at > 10 years. Protocol for overall success: ≥ 15-point improvement in NDI scores, maintenance or improvement in neurologic status, no serious adverse events related to implant or implant/surgical procedure, and no subsequent surgery or intervention classified as "failure.", Results: At 10-year follow-up, 128 (CDA) and 104 (ACDF) patients were available for evaluation. Overall success rate was significantly higher for CDA group (81.3% vs. 66.3%; P = 0.005). The rate of second surgeries at adjacent levels was lower for CDA group (9.7% vs. 15.8%; P = 0.146). NDI scores improved significantly in CDA group (Δ38.3 vs. Δ31.1; P = 0.010). Visual Analog Scale (VAS) neck and arm improved in the CDA group (Δ54.3 vs. Δ49.2; P = 0.119), (Δ58.1 vs. Δ51.6; P = 0.0.60) respectively. About 4.1% of CDA patients and 4.9% of ACDF patients had serious adverse events related to study device. Mean angular motions at index level for BRYAN disc and ACDF were 8.69° and 0.60°, respectively., Conclusion: CDA can preserve and maintain motion in the long term compared with ACDF. There was a trend toward fewer adjacent segment surgeries for BRYAN disc that did not reach significance. Significant improvement in CDA NDI scores may suggest better long-term success for CDA as compared to fusion., Level of Evidence: 2.

Background: Bronchoscopic lung volume reduction (BLVR) using valves and coils has been approved for use since 2003 and 2010, respectively., Objective(s): To study adoption patterns of BLVR in an early-adopting country, and to estimate potential treatment volumes in other European countries., Methods: Therapy- and age-specific volumes for endobronchial valve and coil procedures were obtained from German federal statistics for 2007-2016. Therapy-specific and total BLVR procedure volumes and growth were computed, and patterns in treatment age and device utilization analyzed. Patient volumes for other European countries were predicted using mean German patient volumes of the last 3 data years and age-specific population and emphysema incidences., Results: Over the study period, annual BLVR procedure volumes grew from 91 to 2,053 (+2,256%), reaching a peak of 2,556 procedures in 2013. Coil procedures constituted 36% of the total volume in 2016. Treatment age was stable over time, with highest procedure counts in age group 60-64 years for valves and 65-69 years for coils. A limited increase in device use per procedure was observed. For -Germany, 1,655 newly treated BLVR patients were estimated per year, approximating about 5% of the annual newly diagnosed severe emphysema cases. Predicted volume estimates for other European countries ranged from 1 for Liechtenstein to 1,226 for France., Conclusions: Analysis of -German procedure data show pronounced BLVR therapy uptake in the early years of adoption, with the more recently introduced coil therapy used in about one-third of patients. Estimated patient volumes to date constitute only a small fraction of the severe emphysema population., (© 2018 S. Karger AG, Basel.)

Objective: Anterior lumbar fusion (ALF) is performed by both neurosurgeons and orthopaedic surgeons. The aim of this study was to determine differences between the 2 surgical subspecialties in terms of patient selection and postoperative outcomes after ALF., Methods: A retrospective cohort study of adult patients undergoing ALF in the American College of Surgeons National Surgical Quality Improvement Program database from 2010 to 2014 was performed. Univariate analyses were performed to identify differences in baseline patient demographics, comorbidities, operative characteristics, and 30-day postoperative outcomes between neurosurgery and orthopaedic surgery patients. Multivariate logistic regression analysis was used to determine whether surgical subspecialty was an independent risk factor for postoperative complications., Results: The study included 3182 patients, with 1629 (51.2%) neurosurgery patients and 1553 (48.8%) orthopaedic surgery patients. A greater proportion of neurosurgery patients were >65 years old, were being treated with preoperative steroids, had cardiac or pulmonary comorbidities, and had an American Society of Anesthesiologists classification III or higher. ALF procedures performed by neurosurgeons more frequently involved use of intervertebral devices and bone graft. On multivariate logistic regression analysis, ALF procedures performed by neurosurgeons were independently associated with a higher risk of reoperation (odds ratio = 1.61; 95% confidence interval, 1.02-2.56; P = 0.042) and urinary tract infection (odds ratio = 1.94; 95% confidence interval, 1.02-3.68; P = 0.043)., Conclusions: In addition to differences in baseline patient demographics and comorbidities and operative characteristics, ALF performed by neurosurgeons had a higher risk of 30-day reoperation and urinary tract infection compared with ALF performed by orthopaedic surgeons., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background and purpose - The long-term outcome of reconstruction with extendible prostheses after resection of tumors the proximal tibia in children is unknown. We investigated the functional outcome, complication rate and final limb salvage rate after this procedure. Patients and methods - 42 children who had a primary extendible replacement of the proximal tibia for bone tumor with a Stanmore implant between 1992 and 2013 were identified in the department's database. All notes were reviewed to identify the oncological and functional outcomes, the incidence of complications and the rate of amputation. 20 children were alive at final follow-up. Median follow-up time was 6 years and minimum follow-up for surviving patients was 3 years. Results - The overall limb salvage rate was 35/42; amputation was needed in 7 children. 15 implants were revised with a new implant. The Musculoskeletal Tumor Society Score was 73% (40-93) at final follow-up. The overall complication rate was 32/42. Soft tissue problems were the most common mode of complication, noted in 15 children, whereas structural failure and infection occurred in 12 children each. Use of prostheses with non-invasive lengthening was associated with a higher infection rate as compared with conventional ones (4/6 vs. 8/36) and inferior limb survival. Interpretation - Extendible replacements of the proximal tibia allow for limb salvage and satisfactory late functional outcome but have a high rate of complications. The use of non-invasive lengthening implants has not shown any benefit compared with conventional designs and is, rather, associated with higher risk for infection and amputation.

Medical devices are estimated to account for 6 percent of health expenditures in the US and 7 percent in European Union (EU) countries. Cardiac implants are a large segment of the market, but little is known about their prices. Using 2006-14 data from a large hospital panel survey, this article provides a systematic comparison of prices of cardiac implants between the US and four EU countries. The data reveal that prices were two to six times higher in the US than in Germany, where cardiac implants were generally the cheapest. Prices also varied between EU countries. Prices of coronary stents and pacemakers were higher in France and Italy than in the UK, where prices were similar to those in Germany. The data also confirmed findings of prior studies that found significant price variation between hospitals within a given country. This study found that within- and between-country variations were similar in magnitude. While these findings can help assess whether technology-related policies effectively control the prices of cardiac devices, future research is necessary to establish a causal relationship between prices and several possible explanatory factors and help policy makers understand which mechanisms are available to control device prices.

Background: Despite the recognition that inguinal hernia (IH) repair is cost-effective, repair rates in low- and middle-income countries remain low. Estimated use of mesh in low- and middle-income countries also remains low despite publications about low-cost, noncommercial mesh. The purpose of our study was to assess the current state of IH repair in the northern and transitional zone of Ghana., Materials and Methods: A retrospective review of surgical case logs of IH repairs from 2013 to 2017 in 41 hospitals was performed. Multivariate logistic regression was used to determine predictors of mesh use., Results: Eight thousand eighty male patients underwent IH repair. The range of IH repair in each region was 96 to 295 (overall 123) per 100,000 population. Most cases were performed at district hospitals (84%) and repaired nonurgently (93%) by nonsurgeon physicians (66%). Suture repair was most common (85%) although mesh was used in 15%. The strongest predictor of mesh use was when a surgeon performed surgery (odds ratio [OR] 3.13, P <0.001), followed by surgery being performed in a teaching hospital (OR 2.31, P <0.001). Repair at a regional hospital was a negative predictor of mesh use (OR 0.08, P <0.001) as was the use of general anesthesia (OR 0.40, P = 0.001)., Conclusions: Most IH repairs are performed in district hospitals, by nonsurgeon physicians, and without mesh. Rates of repair and the use of mesh are higher than previous estimates in Ghana and Sub-Saharan Africa but not as high as high-income countries., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: This study aimed to assess the oral impact on daily performance and its association with sociodemographic characteristics, tooth pain, need for prosthesis, and periodontal disease of adults in the state of São Paulo, Brazil., Methods: This was a cross-sectional epidemiological study with secondary data obtained from the Oral Health Conditions Project- 2015 conducted in 163 municipalities in the state of São Paulo with the participation of 17,560 individuals. This study evaluated adults in the age-range between 35-44 years (n = 5,855), selected by means of probabilistic cluster sampling in two stages. The outcome variable was the OIDP (Oral Impacts on Daily Performances), obtained by using this instrument to assess daily activities (eating, speaking, oral hygiene, relaxation, sports practice, smile, study/work, social contact, and sleep). The independent variables were collected and grouped into three blocks: Block 1 (sex, age group, and ethnic group); Block 2 (household income and education); and Block 3 (tooth pain, need for prosthesis, bleeding, calculus, and periodontal pockets). A hierarchical multiple logistic regression analysis was performed considering the complex cluster sampling plan. Each observation was assigned a specific weight, depending on the location, which resulted in weighted frequencies adjusted for the effect of outlining., Results: the female sex (p<0.0001), ethnic group black/mulatto (p<0.0001), low household income (p = 0.0112), up to 8 years of education (p<0.0001), tooth pain (p<0.0001), presence of bleeding (p<0.0001), and presence of periodontal pockets (p<0.0001) had greater oral impact on daily performance., Conclusion: sociodemographic characteristics, tooth pain, and presence of periodontal disease were associated with oral impact on daily performance of the adult population in the state of São Paulo, Brazil., Competing Interests: The authors have declared that no competing interests exist.

Precision medicine can be defined as the prevention, investigation and treatment of diseases taking individual variability into account. There are multiple ways in which the field of precision medicine may be advanced; however, recent innovations in the fields of electronics and microfabrication techniques have led to an increased interest in the use of implantable biosensors in precision medicine. Implantable biosensors are an important class of biosensors because of their ability to provide continuous data on the levels of a target analyte; this enables trends and changes in analyte levels over time to be monitored without any need for intervention from either the patient or clinician. As such, implantable biosensors have great potential in the diagnosis, monitoring, management and treatment of a variety of disease conditions. In this review, we describe precision medicine and the role implantable biosensors may have in this field, along with challenges in their clinical implementation due to the host immune responses they elicit within the body., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Aims: There is little information about the optimum number of implants to be used in the surgical treatment of idiopathic scoliosis. Retrospective analysis of prospectively collected data from the Swedish spine register was undertaken to discover whether more implants per operated vertebra (implant density) leads to a better outcome in the treatment of idiopathic scoliosis. The hypothesis was that implant density is not associated with patient-reported outcomes, the correction of the curve or the rate of reoperation., Patients and Methods: A total of 328 patients with idiopathic scoliosis, aged between ten and 20 years at the time of surgery, were identified in the Swedish spine register (Swespine) and had patient reported outcomes including the Scoliosis Research Society 22r instrument (SRS-22r) score, EuroQol 5 dimensions quality of life, 3 level (EQ-5D-3L) score and a Viual Analogue Score (VAS) for back pain, at a mean follow-up of 3.1 years and reoperation data at a mean follow-up of 5.5 years. Implant data and the correction of the curve were assessed from radiographs, preoperatively and a mean of 1.9 years postoperatively. The patients were divided into tertiles based on implant density. Data were analyzed with analysis of variance, logistic regression or log-rank test. Some analyses were adjusted for gender, age at the time of surgery, the flexibility of the major curve and follow-up., Results: The mean number of implants per operated vertebra in the low, medium and high-density groups were 1.36 (1.00 to 1.54), 1.65 (1.55 to 1.75) and 1.91 (1.77 to 2.00), respectively. There were no statistically significant differences in the correction of the curve, the SRS-22r total score, EQ-5D-3L index or number of reoperations between the groups (all p > 0.34). In the SRS-22r domains, self-image was marginally higher in the medium implant density group (p = 0.029) and satisfaction marginally higher in the high implant density group (p = 0.034)., Conclusion: These findings suggest that there is no clear advantage in using a high number of implants per operated vertebra in the surgical treatment of patients with idiopathic scoliosis. Cite this article: Bone Joint J 2018;100-B:1080-6.

Closed-loop drug delivery promises autonomous control of pharmacotherapy through the continuous monitoring of biomarker levels. For decades, researchers have strived for portable closed-loop systems capable of treating ambulatory patients with chronic conditions such as diabetes mellitus. After years of development, the first of these systems have left the laboratory and entered commercial use. This long-awaited advance reflects recent development of chronically stable implantable biosensors able to accurately measure biomarker levels in vivo. This review discusses the role of implantable biosensors in closed-loop drug delivery applications, with the intent to provide a resource for engineers and researchers studying such systems. We provide an overview of common biosensor designs and review the principle challenges in implementing long indwelling sensors: namely device sensitivity, selectivity, and lifetime. This review examines novel advances in transducer design, biological interface, and material biocompatibility, with a focus on recent academic and commercial work which provide successful strategies to overcome perennial challenges. This review focuses primarily on the topics of closed-loop glucose control and continuous glucose monitoring biosensors, which make up the overwhelming majority of published research in this area. We conclude with an overview of recent advances in closed-loop systems targeting applications outside blood glucose management., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Lumbar fusion surgery is an established procedure for the treatment of low back pain. Despite the wide set of alternative fusion techniques and existing devices, uniform guidelines are not available yet and common surgical trends are scarcely investigated.The purpose of this UK-based study was to provide a descriptive portrait of current surgeons' practice and implant preferences in lumbar fusion surgery.A UK-based in-person survey was designed for this study and submitted to a group of consultant spinal surgeons (n = 32). Fifteeen queries were addressed based on different aspects of surgeons' practice: lumbar fusion techniques, implant preferences, and bone grafting procedures. Answers were analyzed by means of descriptive statistics.Thirty-two consultant spinal surgeons completed the survey. There was clear consistency on the relevance of a patient-centered management (82.3%), along with a considerable variability of practice on the preferred fusion approach. Fixation surgery was found to be largely adopted (96.0%) and favored over stand-alone cages. With regards to the materials, titanium cages were the most used (54.3%). The geometry of the implants influenced the choice of lumbar cages (81.3%). Specifically, parallel-shape cages were mostly avoided (89.2%) and hyperlordotic cages were preferred at the lower lumbar levels. However, there was no design for lumbar cages which was consistently favored. Autograft bone graft surgeries were the most common (60.0%). Amongst the synthetic options, hydroxyapatite-based bone graft substitutes (76.7%) in injectable paste form (80.8%) were preferred.Current lumbar fusion practice is variable and patient-oriented. Findings from this study highlight the need for large-scale investigative surveys and clinical studies aimed to set specific guidelines for certain pathologies or patient categories.

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Introduction: In addition to patient characteristics, consideration of length of construct to number of anchored levels ratio and rod diameter should be a part of preoperative planning to minimize implant-related complications (IRCs). IRCs including rod breakage, anchor dislodgement, and pullout are among the most common adverse events in traditional growing rods (TGRs). The current study hypothesized that anchor type and configuration are associated with IRC., Methods: Patients with (1) age ≤10 years at surgery; (2) spine-based dual TGR; (3) minimum 2-year follow-up; and (4) available imaging. Cephalad and caudal foundations were grouped based on the number of instrumented levels and anchor type. All radiographs were reviewed. Based on the results, a "construct levels / anchored levels" (CL/AL) ratio was calculated, which is the number of levels spanned by instrumentation divided by the number of levels with bone-anchor fixation. Receiver operating characteristic curve was used to define the CL/AL threshold., Results: 274 patients divided into patients with complications (IRC+, n = 140) and without complications (IRC-, n = 134) groups. Mean follow-up was 6.3 years (2.1-18.0 years). No significant differences in age, gender, body mass index, ambulatory status, etiology, primary curve size, T1-S1 height, coronal and sagittal balance, and rod material were observed between the two groups. Comparative analysis showed that connector type, presence and location of crosslinks, number of levels instrumented, number and type of anchors, presence of pelvic fixation, and mirroring of cephalad and caudal foundations were not different. However, maximum kyphosis and rod diameter were significantly different. The CL/AL ratio threshold was 3.5. Multivariate analysis of kyphosis, rod diameter, and CL/AL ratio showed a significant association with IRC (p < .05)., Discussion and Conclusion: Although patient characteristics like kyphosis have been proven to be associated with instrumentation failure, it is a combination of characteristics that include rod diameter and CL/AL ratio that showed significant correlation with IRC. Validation of the CL/AL ratio is recommended., (Copyright © 2017 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.)

Background: Studies have demonstrated that physicians are often unaware of prescription drug, laboratory, diagnostic, and surgical supply costs., Objective: To investigate the effects of increased physician awareness on infection incidence and surgical device cost containment., Methods: Within our institution, physicians were informed of individual, independently adjudicated, craniotomy and ventricular shunt infection incidence and rankings among peers, after which a protocol aimed at reducing skin bacterial burden was implemented for craniotomies. Physicians were also made aware of the costs for shunts and dural substitutes as well as available alternatives., Results: The combined craniotomy and ventricular shunt infection incidence significantly decreased by 37.5% from 3.2% over May 2011 to April 2015 (132 infections/4137 procedures) to 2.1% over May 2015 to April 2016 (26 infections/1250 procedures; P = .041). The average annual cost savings was $234 175 from preventing postoperative craniotomy infections and $121 125 from preventing postoperative ventricular shunt infections. Total supply costs of ventricular shunts significantly decreased by 26% from $2345 per procedure in fiscal year 2015 to $1747 per procedure in fiscal year 2016 (P < .001). Total supply cost of dural grafts significantly decreased by 54% from $191 per procedure in fiscal year 2015 to $88 per procedure in fiscal year 2016 (P < .001). In total, all initiatives in this study resulted in an estimated annual savings of $567 062., Conclusion: Physician awareness of outcomes and costs resulted in increasing the quality of care, while at the same time reducing the cost.

Objectives: The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006-2016) and to provide recommendations on 'best practice' approaches., Settings and Participants: A systematic search on CIR was employed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect and the Scopus database, EMBASE. After identifying the existing CIRs, an aggregative approach will be used to explore key elements emerging in the identified registries., Results: The following 82 registries were identified: 18 implantable cardioverterdefibrillator (ICD) registries, 7 cardiac resynchronisation therapy (CRT) registries, 5 pacemaker registries and 6 cardiovascular implantable electronic device registries which combined ICD, pacemaker and CRT implantation data; as well as 22 coronary stent registries and 24 transcatheteraortic heart valve implantation registries. While 71 national or local registries are from a single country, 44 are from European countries and 9 are located in USA. The following criteria have been summarised from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis., Conclusions: Registries provide a 'real-world' picture for patients, physicians, manufacturers, payers, decision-makers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and therefore approval issues of the medical device; for payers CIRs provide evidence on the medical device benefit and drive the decision whether the product should be reimbursed or not; for hospitals CIRs' data are important for sound procurement decisions, and CIRs also help patients and their physicians to joint decision-making which of the products is the most appropriate., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective Inlay arthroplasty (IA) has seen growing interest as a new primary arthroplasty intervention for patients that need to transition from biology to joint replacement. The purpose of this study was to investigate the biological response to this procedure. Design Patients presenting with symptomatic mono- or bicompartmental arthrosis and varus malalignment underwent IA and concurrent medial open wedge high tibial osteotomy (HTO). A subset of patients required hardware removal and consented to second-look arthroscopy without biopsy allowing for assessment of IA components and compartment-specific findings related to implant fixation, cartilage flow, propagation of lesions, and opposing tibial surfaces. Results In a series of 41 knees (35 patients) treated with combined IA and HTO (mean varus >7°), 26 knees (23 patients, 18 male, 5 female) with a mean age of 52 years (range = 43-67) required HTO plate removal. Concurrent second look arthroscopy was performed at a mean of 14 months (range = 12-19) following the index procedure. On probing, all arthroplasty components showed solid fixation without gap formation. On the medial femoral condyle, 15 mm implants ( n = 14) showed a peripheral cartilage flow of 12% (range = 5% to 25%), 20 mm implants ( n = 12) of 9% (range 5% to 15%), and trochlear implants ( n = 12) of 20% (range 10% to 40%). No progressive deterioration of the index defects or progression of tibial and retropatellar grades were seen. Conclusion Joint surface reconstruction using IA showed stable fixation with peripheral cartilage coverage ranging from 9% to 20% and no further chondral damage on opposing surfaces. Future clinical effectiveness studies are required to support the positive biological integration.

This document announces the deletion of four Healthcare Common Procedure Coding System (HCPCS) codes from the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment.

Hammertoe deformities are one of the most common foot deformities, affecting up to one third of the general population. Fusion of the joint can be achieved with various devices, with the current focus on percutaneous Kirschner (K)-wire fixation or commercial intramedullary implant devices. The purpose of the present study was to determine whether surgical intervention with percutaneous K-wire fixation versus commercial intramedullary implant is more cost effective for proximal interphalangeal joint arthrodesis in hammertoe surgery. A formal cost-effectiveness analysis using a decision analytic tree model was conducted to investigate the healthcare costs and outcomes associated with either K-wire or commercial intramedullary implant fixation. The outcomes assessed included long-term costs, quality-adjusted life-years (QALYs), and incremental cost per QALY gained. Costs were evaluated from the healthcare system perspective and are expressed in U.S. dollars at a 2017 price base. Our results found that commercial implants were minimally more effective than K-wires but carried significantly higher costs. The total cost for treatment with percutaneous K-wire fixation was $5041 with an effectiveness of 0.82 QALY compared with a commercial implant cost of $6059 with an effectiveness of 0.83 QALY. The incremental cost-effectiveness ratio of commercial implants was $146,667. With an incremental cost-effectiveness ratio of >$50,000, commercial implants failed to justify their proposed benefits to outweigh their cost compared to percutaneous K-wire fixation. In conclusion, percutaneous K-wire fixation would be preferred for arthrodesis of the proximal interphalangeal joint for hammertoes from a healthcare system perspective., (Copyright © 2017 The American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.)