Barbed sutures and skin adhesives improve wound closure in hip and knee arthroplasty.

PURPOSE: This study aimed to formulate evidence-based recommendations for optimising wound management in hip and knee arthroplasty by exploring alternative methods such as barbed sutures and skin adhesives. METHODS: A Delphi panel, comprising seven orthopaedic surgeons, one musculoskeletal infectious disease specialist, and one health economics expert, was convened to evaluate the use of barbed sutures and skin adhesives for wound closure in hip and knee arthroplasty. Two systematic reviews informed the development of questionnaires, with panelists ranking their agreement on statements using a 5-point Likert scale. Consensus was achieved if ≥75% agreement. Unresolved statements were revisited in a second round. RESULTS: Consensus was reached on 11 statements, providing evidence-based recommendations. The expert panel advocates for a multilayer watertight technique using barbed sutures to prevent surgical site infections (SSI), reduce complications, shorten surgical times, optimise resources and improve cosmetic appearance. For skin closure, the panel recommends topical adhesives to decrease wound dehiscence, enhance cosmetic appearance, promote patient compliance, prevent SSIs, and optimise resources. CONCLUSION: The Delphi consensus by Italian total joint arthroplasty experts underscores the pivotal role of barbed sutures and skin adhesives in optimising outcomes. While guiding clinical decision-making, these recommendations are not prescriptive and should be adapted to local practices. The study encourages further research to enhance current evidence. LEVEL OF EVIDENCE: Level III.

International Delphi Study on Wound Closure and Incision Management in Joint Arthroplasty Part 2: Total Hip Arthroplasty.

BACKGROUND: This modified Delphi study aimed to develop a consensus on optimal wound closure and incision management strategies for total hip arthroplasty (THA). Given the critical nature of wound care and incision management in influencing patient outcomes, this study sought to synthesize evidence-based best practices for wound care in THA procedures. METHODS: An international panel of 20 orthopedic surgeons from Europe, Canada, and the United States evaluated a targeted literature review of 18 statements (14 specific to THA and 4 related to both THA and total knee arthroplasty). There were 3 rounds of anonymous voting per topic using a modified 5-point Likert scale with a predetermined consensus threshold of ≥ 75% agreement necessary for a statement to be accepted. RESULTS: After 3 rounds of voting, consensus was achieved for all 18 statements. Notable recommendations for THA wound management included (1) the use of barbed sutures over non-barbed sutures (shorter closing times and overall cost savings); (2) the use of subcuticular sutures over skin staples (lower risk of superficial infections and higher patient preferences, but longer closing times); (3) the use of mesh-adhesives over silver-impregnated dressings (lower rate of wound complications); (4) for at-risk patients, the use of negative pressure wound therapy over other dressings (lower wound complications and reoperations, as well as fewer dressing changes); and (5) the use of triclosan-coated sutures (lower risk of surgical site infection) over standard sutures. CONCLUSIONS: Through a structured modified Delphi approach, a panel of 20 orthopedic surgeons reached consensus on all 18 statements pertaining to wound closure and incision management in THA. This study provides a foundational framework for establishing evidence-based best practices, aiming to reduce variability in patient outcomes and to enhance the overall quality of care in THA procedures.

International Delphi Study on Wound Closure and Dressing Management in Joint Arthroplasty: Part 1: Total Knee Arthroplasty.

BACKGROUND: The purpose of this modified Delphi study was to obtain consensus on wound closure and dressing management in total knee arthroplasty (TKA). METHODS: The Delphi panel included 20 orthopaedic surgeons from Europe and North America. There were 26 statements identified using a targeted literature review. Consensus was developed for the statements with up to three rounds of anonymous voting per topic. Panelists ranked their agreement with each statement on a five-point Likert scale. An a priori threshold of ≥ 75% was required for consensus. RESULTS: All 26 statements achieved consensus after three rounds of anonymous voting. Wound closure-related interventions that were recommended for use in TKA included: 1) closing in semi-flexion versus extension (superior range of motion); 2) using aspirin for venous thromboembolism prophylaxis over other agents (reduces wound complications); 3) barbed sutures over non-barbed sutures (lower wound complications, better cosmetic appearances, shorter closing times, and overall cost savings); 4) mesh-adhesives over other skin closure methods (lower wound complications, higher patient satisfaction scores, lower rates of readmission); 5) silver-impregnated dressings over standard dressings (lower wound complications, decreased infections, fewer dressing changes); 6) in high-risk patients, negative pressure wound therapy over other dressings (lower wound complications, decreased reoperations, fewer dressing changes); and 7) using triclosan-coated over non-antimicrobial-coated sutures (lower risks of surgical site infection). CONCLUSIONS: Using a modified Delphi approach, the panel achieved consensus on 26 statements pertaining to wound closure and dressing management in TKA. This study forms the basis for identifying critical evidence supported by clinical practice for wound management to help reduce variability, advance standardization, and ultimately improve outcomes during TKA. The results presented here can serve as the foundation for knowledge, education, and improved clinical outcomes for surgeons performing TKAs.

Technical Note: Tibial Spine Avulsion Treatment with Arthroscopic Reduction and Internal Fixation with Kirschner Wires in Skeletally Immature Patients.

INTRODUCTION: Tibial spine avulsion injury, tibial eminence injury, tibial spine fracture, and anterior cruciate ligament (ACL) avulsion are multiple terms that express the same pathological condition. It can be encountered both in the pediatric and adult population. A wide array of surgical techniques have been proposed to manage displaced tibial spine avulsions. Anyway, insufficient evidence is currently available to prefer one fixation technique over another, and a gold-standard arthroscopy-based technique is still missing. In this article, we describe a mini-invasive, safe and user-friendly technique for arthroscopic reduction and internal fixation of displaced tibial eminence fractures. MATERIALS AND METHODS: Standard and patient-specific accessory arthroscopic portals allow for full access to knee visualization and management of concomitant intraarticular lesions. After performing the debridement of the inflammatory tissue and the release of eventual interposed tissues in the fracture site, the tibial eminence avulsion can be reduced by using a less-invasive bone impactor. With the knee flexed to 90°, the fracture fragments are then synthesized (under fluoroscopic control) with three thin Kirschner wires inserted in a proximal-distal direction in a cross-shaped geometry. RESULTS: This technique allows a fast surgical and hospitalization time, a punctiform arthrotomy, proximal tibial physis preservation, and an early rehabilitation program. CONCLUSIONS: This novel technique seems attractive and very promising since it is respectful of the epiphyseal growth plates and is thus suitable for children and adolescents.

Telerehabilitation Is a Valid Option for Total Knee Arthroplasty Patients: A Retrospective Pilot Study Based on Our Experience during the COVID-19 Pandemic.

INTRODUCTION: Total knee arthroplasty is an effective operation. Post-surgery rehabilitation, based on early and intensive progressive exercise programs, plays a substantial role and telerehabilitation can be an effective safe option. This retrospective study aimed to compare traditional in-presence rehabilitation and telerehabilitation for total knee arthroplasty, based on our experience during the Italian COVID-19 lockdown. MATERIALS AND METHODS: We retrospectively analyzed 164 patients (94 females and 70 males) enrolled in 2020 within 2 weeks after total knee replacement to perform post-operative outpatient rehabilitation. The clinical results of 82 patients (mean age 66.8 ± 10.2 years) performing telerehabilitation with those obtained from a similar cohort of 82 patients (mean age 65.4 ± 11.8 years) performing traditional in-presence outpatient rehabilitation were compared. Clinical outcomes were examined by comparing the gait speed (Time Up and Go-TUG test), the range of motion, the pain intensity (VAS), the functional status (Oxford Knee Score-OKS and Knee injury and Osteoarthritis Outcome Score-KOOS) and the overall satisfaction (Self-administered patient satisfaction scale) 12 weeks after the beginning of the physiotherapeutic protocol. RESULTS: Telerehabilitation was non-inferior to traditional in-presence rehabilitation in all of the investigated areas and no statistical difference in terms of effectiveness was detected at 12 weeks, as confirmed by the respective patient-reported outcome scores such as TUG test (reduced from 20 ± 2 s to 12 ± 1.5 s for the telerehab cohort and from 18 ± 1.5 s to 13.1 ± 2 s for the in-presence rehabilitation one), pain VAS, OKS (improved from 22 ± 1.3 to 36 ± 2.7 for the telerehab cohort and from 23 ± 2.1 to 35.1 ± 4.2 for the in-presence group), KOOS (improved from 46.2 ± 10.2 to 67.4 ± 3.8 for the telerehabilitation cohort and from 48.4 ± 8.4 to 68.3 ± 6.6 for the other group), and the Self-administered patient satisfaction scale (more than two-thirds of patients globally satisfied with the results of their surgery in both groups). CONCLUSION: The telerehabilitation program was effective after total knee replacement and yielded clinical outcomes that were not inferior to conventional outpatient protocols.

What Is the Inpatient Cost of Hip Replacement? A Time-Driven Activity Based Costing Pilot Study in an Italian Public Hospital.

The emphasis on value-based payment models for primary total hip replacement (THA) results in a greater need for orthopaedic surgeons and hospitals to better understand actual costs and resource use. Time-Driven Activity-Based Costing (TDABC) is an innovative approach to measure expenses more accurately and address cost challenges. It estimates the quantity of time and the cost per unit of time of each resource (e.g., equipment and personnel) used across an episode of care. Our goal is to understand the true cost of a THA using the TDABC in an Italian public hospital and to comprehend how the adoption of this method might enhance the process of providing healthcare from an organizational and financial standpoint. During 2019, the main activities required for total hip replacement surgery, the operators involved, and the intraoperative consumables were identified. A process map was produced to identify the patient's concrete path during hospitalization and the length of stay was also recorded. The total inpatient cost of THA, net of all indirect costs normally included in a DRG-based reimbursement, was about EUR 6000. The observation of a total of 90 patients identified 2 main expense items: the prosthetic device alone represents 50.4% of the total cost, followed by the hospitalization, which constitutes 41.5%. TDABC has proven to be a precise method for determining the cost of the healthcare delivery process for THA, considering facilities, equipment, and staff employed. The process map made it possible to identify waste and redundancies. Surgeons should be aware that the choice of prosthetic device and that a lack of pre-planning for discharge can exponentially alter the hospital expenditure for a patient undergoing primary THA.

Pisiform Bone Dislocation in a Pediatric Patient: What is the Best Treatment? Case Report and Review of the Literature.

Traumatic dislocation of the pisiform bone (PB) is a rare injury of the carpal bones, especially in pediatric patients. A few cases were reported, and there is no consensus about the treatment. Each author supports his own method, such as an open reduction internal fixation (ORIF) approach or a closed reduction. However, failures of both techniques with recurrent dislocation of the PB have been reported in the literature. In this article, a fracture dislocation of the PB was treated with ORIF in an 11-year-old boy with a greenstick radial fracture. In addition, a review of the literature about pisiform fracture dislocation in children has been made.

Platelet-Rich Plasma and Adipose-Derived Mesenchymal Stem Cells in Association with Arthroscopic Microfracture of Knee Articular Cartilage Defects: A Pilot Randomized Controlled Trial.

Background: This study aims to compare the effects of platelet-rich plasma (PRP) alone or in combination with adipose-derived mesenchymal stem cells (AD-MSCs) in patients affected by cartilage defects, undergoing knee arthroscopic microfracture. Methods: Thirty-eight patients diagnosed with a knee monocompartmental cartilage defect (Outerbridge grade IV) on the MRI, underwent an arthroscopic procedure. After the confirmation of the lesion, they all received the same bone marrow stimulation technique (microfracture) and were randomized into two groups: the first one had additional PRP injection (group A), while the second received PRP and AD-MSC injection (group B). Knee assessment and pain score were documented with Knee Injury Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, Short-Form (SF) 12, and Visual Analogue Scale (VAS) before the treatment and at 1, 3, 6, and 12 months of follow-up postoperatively. An additional arthroscopic procedure, performed in four patients for a subsequent meniscal lesion, let us evaluate cartilage evolution by performing a macro/microscopical assessment on cartilage biopsy specimens. Results: At the 12-month follow-up, both groups showed a comparable functional improvement. The scores on the IKDC form, KOOS, pain VAS, and SF-12 significantly improved from baseline (p < 0.05) to 12 months postoperatively in both treatment groups. The four second-look arthroscopies showed a complete repair of the articular defects by smooth solid cartilage layer, with a good chondrocytic population, in both groups. A thick smooth hyaline-like cartilage with a predominantly viable cell population and normal mineralization (a form closely resembling native tissue) was observed in group B. Conclusions: Modern regenerative medicine techniques, such as PRP and AD-MSC, associated with traditional arthroscopic bone marrow stimulating techniques, seem to enhance cartilage restoration ability. The preliminary results of this pilot study encourage the synergic use of these regenerative modulating systems to improve the quality of the regenerated cartilage.

Stem Cells in Orthopedic Web Information: An Assessment with the DISCERN Tool.

OBJECTIVE: Regenerative medicine is experiencing a strong expansion worldwide, including the treatment of some common orthopedic pathologies, with an increase in physicians adopting these technologies. This growing interest has been associated with an equally significant spread of websites dedicated to public information on this topic, often lacking scientific bases. This study aims to evaluate the quality of information on the World Wide Web about stem cells for cartilage disorders in orthopedic practice. DESIGN: On February 19, 2021 we performed a search on Google using as keywords "cartilage stem cells," considering only the freely accessible sites in Italian, English, French, and Spanish. We selected the first 50 valid results for each language and evaluated them using the DISCERN scale. RESULTS: A total of 249 sites were observed, of which 49 were discarded as duplicates (8) or not relevant to the topic (41). Of the 200 sites surveyed, 47 were affiliated to a singular surgeon (23.5%), 31 to private stakeholders (15.5%), 73 to information sites (36.5%), 8 to public hospitals (4%), 13 to universities (6.5%), and 28 referred to international scientific journals (14%). Only 76 sites (38%) were rated as fair or better, while the remaining 124 (62%) were classified as poor or very poor. CONCLUSIONS: The quality of the information promoted for stem cells in orthopedics is generally low, although a significant minority of the sites offers good quality information. A greater commitment on the part of surgeons and other stakeholders is desirable to promote information on regenerative medicine through scientific criteria supported by adequate literature.

Non-Surgical Treatment of Knee Osteoarthritis: Multidisciplinary Italian Consensus on Best Practice.

The aim of this document is to provide a set of indications on the national best practice management of knee osteoarthritis based on an analysis of the existing literature and the contribution of experts in the field. During the first phase of the project, in agreement with the multidisciplinary panel of experts, the main guidelines on the topic were selected. Each guideline was assessed through the AGREEII system to identify their strong/weak points and a summary of the recommendations contained in the various documents was drawn up. The panel drew up a list of therapeutic options to be included in the document and some of these topics were selected for in-depth analysis and review. The search strategy for the required literature reviews was constructed using the PICOS approach. The results obtained from the literature reviews, the in-depth analyses conducted by the members of the scientific societies involved and the analysis of the existing guidelines enabled an initial draft of the consensus document to be elaborated. This document was examined at the consensus conference held on 28 May 2019, in the presence of a multidisciplinary group consisting of members of the various scientific societies involved. Single recommendations were discussed in work groups with a view to combining the indications given by the literature examined with the experience of the specialists involved. The recommendations discussed were then put to the vote in a plenary assembly. The final document contains 26 practice recommendations which leading specialists involved in the management of knee OA in Italy agree upon.

The rise of registry-based research: a bibliometric analysis.

Background and purpose - The main purpose of arthroplasty registries is to collect information on patients, techniques, and devices to monitor and improve the outcome of the specific procedure. This study analyses the role played by registries in the orthopedic research community and describes publication trends, characteristics, and patterns of this field of research.Patients and methods - A descriptive-bibliometric review was conducted. Scopus was the database used for the research. All articles published from 1991 to December 2020 containing keywords related to registries and arthroplasty were considered. In particular, the following dimensions were analyzed in detail: (i) papers/year; (ii) journals; (iii) countries; (iv) research growth rate; (v) collaboration among countries. VOSviewer software was used to perform the bibliometric analysis. Finally, the 50 most cited papers of the last 10 years were briefly analyzed.Results - 3,933 articles were identified. There has been growing interest in the topic since 2010. Acta Orthopaedica ranked first for the number of articles published. The country with the largest number of articles citing registries was the United States, followed by the United Kingdom and Sweden. The relative number of articles per 100,000 inhabitants is 0.60 for Europe and 0.38 for the United States. The literature in this research area has an average yearly growth rate of 28%.Interpretation - The publication rate in the field of arthroplasty registries is constantly growing with a noteworthy impact in the evolution of this research and clinical area. The growth rate is significantly higher than that of arthroplasty literature (28% vs. 10%) and the collaboration among countries is strong and increasing with time.

Management of superficial and deep surgical site infection: an international multidisciplinary consensus.

Surgical site infections represent a considerable burden for healthcare systems. To obtain a consensus on the impact and future clinical and economic needs regarding SSI management in an era of multidrug resistance. A modified Delphi method was used to obtain consensus among experts from five European countries. The Delphi questionnaire was assembled by a steering committee, verified by a panel of experts and administered to 90 experts in 8 different surgical specialities (Abdominal, Cancer, Cardiac, General surgery, Orthopaedic, Thoracic, Transplant and Vascular and three other specialities (infectious disease, internal medicine microbiology). Respondents (n = 52) reached consensus on 62/73 items including that resistant pathogens are an increasing matter of concern and increase both treatment complexity and the length of hospital stay. There was strong positive consensus on the cost-effectiveness of early discharge (ED) programs, improvement of quality of life with ED and association between increased length of stay and economic burden to the hospital. However, established ED protocols were not widely available in their hospitals. Respondents expressed a positive consensus on the usefulness of antibiotics that allow ED. Surgeons are aware of their responsibility in an interdisciplinary team for the treatment of SSI, and of the impact of multidrug-resistant bacteria in the context of SSI. Reducing the length of hospital stays by applying ED protocols and implementing new treatment alternatives is crucial to reduce harm to patients and costs for the hospital.

Evidence based rehabilitation after hip arthroplasty.

BACKGROUND: Hip arthroplasty is considered the treatment of choice to improve the quality of life of patients affected by degenerative arthritis. The post-op rehabilitation regimen, however, is still a matter of debate. The goal of this study was to perform a systematic review of the available best evidence to provide recommendations for rehabilitation after hip arthroplasty. MATERIALS AND METHODS: Biomedical databases were accessed to identify guidelines, systematic reviews and randomised controlled trials addressing rehabilitation after hip arthroplasty published between 2004 and 2019. Studies were selected and extracted by two independent evaluators with standardised tools. RESULTS: 1 guideline, 8 systematic reviews and 5 randomised controlled trials were included. All included papers were organised according the available evidence of clinical course chronology both in pre- and post-operation rehabilitation up to 6 weeks and thereafter. Although the value of a rehabilitation program after hip arthroplasty is universally recognised, the exact timing and number of sessions is still unknown. A solid literature review allows us to partially answer to this question. CONCLUSIONS: Evidence-based rehabilitation recommendations are proposed according to literature research findings. Clinical practice is still somewhat dependent on dogma and traditions, highlighting the need for additional high-quality clinical studies to address areas of uncertainty.

[Orthopedics between reason and passion. Guidelines and shadow lines.] / Ortopedia tra ragione e passione. Linee guida e linee d'ombra.

For over 20 years the Evidence-Based Orthopaedics Working Group (GLOBE) has been promoting evidence-based medicine (EBM) in orthopaedics and traumatology. However, despite a constant and wide-ranging editorial production and fruitful collaborations with colleagues and institutions at national and international level, the orthopaedic scientific community finds it difficult to recognize the EBM model as a solid reference: there are few guidelines available, there is little awareness of their usefulness, and the complexity of the methodology of production and adaptation of documents widens the gap between the orthopaedic real world and that of clinical epidemiology. After a quick analysis of the causes of this contrast, the authors reflect on the possible solutions to the problem, and propose to collaborate for a simplification of the guidelines production methodology, using innovative models of literature review, which have proved to be effective to make the best knowledge available quickly during the CoViD-19 pandemic.

[Italian Arthroplasty Registry: learning curve and optimization of data entry procedures.] / Registro Italiano Artroprotesi: curva di apprendimentoe ottimizzazione delle procedure di immissione dei dati.

Arthroplasty registries represent a fundamental tool for the production of evidence in total joint replacement. Italy started in 2005 a national registry (Italian Arthroplasty Registry - RIAP) organised as federation of regional registries under the coordination of the Istituto Superiore di Sanità. However, data collection still appears to be hardened by the additional workload required from clinicians. The aim of the study was to evaluate the data entry times for an inexperienced operator and the relative learning curve. The analysis carried out shows that after 15 cases, a plateau of about two minutes is reached for the compilation of a single case of primary hip and knee arthroplasty, up to 4 minutes for the shoulder and for revision surgery. The work burden for the orthopedist does not seem to justify the reluctance in data collection observed in these years of RIAP experience.

Total knee arthroplasty in Italy: reflections from the last fifteen years and projections for the next thirty.

PURPOSE: Annual rates of knee arthroplasty are increasing in all developed countries, imposing a significant economic and organizational burden; it is crucial to forecast the future need for knee arthroplasty, to assist stakeholders in planning strategies and investments, especially in a country like Italy, with the largest proportion of elderly citizens in Europe. Few epidemiological studies have been performed worldwide to estimate the demand for future knee replacement, and a variety of methods have been proposed. METHODS: We investigated the epidemiology of knee arthroplasty performed in Italy in the last 15 years and projected incidence rates up to the year 2050, utilizing, comparing, and adapting the available methodologies. RESULTS: From 2001 to 2016, 812,639 primary TKA were performed in Italy on patients over 40. The total number of surgeries increased by 262% with an average annual growth rate of 6.6%. CONCLUSIONS: Adopting the best fitting projection method, an increase of 45% in incidence rate is expected for 2050.

Cross-cultural adaptation and validation of the Italian version of the Hip disability and Osteoarthritis Outcome Score (HOOS).

OBJECTIVE: To create a translated version of the HOOS to fit the Italian population and to test its psychometric properties and validity in hip osteoarthritis (OA) patients undergoing total hip arthroplasty (THA). DESIGN: The HOOS Italian version was developed according to published international guidelines that include preparation, forward translation and reconciliation, backward translation, review and harmonization, and proof reading. The Italian HOOS was administered to 145 patients (mean age 65.7 ± 11.6 years, 34-89, 58.6% women) undergoing THA. The following psychometric properties were evaluated: internal consistency (Cronbach's alpha); test-retest reliability (Pearson's r and intra-class correlation coefficient, ICC); convergent validity (Spearman's rho between HOOS and SF-36); responsiveness (comparison of pre/post-THA scores, Wilcoxon signed rank test). Interpretability (floor and ceiling effects, skewness and kurtosis indexes) and acceptability (time to compiling, missing answers, and autonomy in compilation) were also evaluated. RESULTS: Translation and transcultural adaptation were conducted in accordance with the international recommendation. The translation was deemed understandable and appropriate as to the transcultural adaptation. None of the patients reported to have met any difficulties in reading and understanding the HOOS items. Internal consistency and test-retest reliability were good for each HOOS subscale (Cronbach's alpha ≥0.7, Pearson's r and ICC > 0.80). Convergent validity showed the highest correlations (Spearman's rho > 0.5) between HOOS and SF-36 subscales relating to similar dimensions. As to responsiveness, all HOOS subscales scores improved significantly after THA (p < 0.01). Interpretability was acceptable despite ceiling effect in post-THA assessment. Acceptability was good: HOOS resulted easy and quick to fill out (12 min on average). CONCLUSIONS: The HOOS was successfully cross-culturally adapted into Italian. The Italian HOOS showed good psychometric properties therefore it can be useful to assess outcomes in OA patients after THA. This study provided a basis for its use within the Italian Arthroplasty Registry and for future clinical trials.

The role of dalbavancin in the multi-disciplinary management of wound infections in orthopaedic surgery.

Antimicrobial resistance is continuously increasing among bacterial clinical isolates (especially methicillin resistance in Staphylococcus aureus, MRSA), negatively impacting on outcomes of patients with Surgical Site Infections (SSIs). A multi-disciplinary team work is essential for SSIs prevention and for the choice of antibiotic therapy of orthopaedic SSIs. In particular, an Antibiotic Stewardship (AS) approach is recommended for preserving the activity of old and new antimicrobials. Dalbavancin is a novel antimicrobial agent, belonging to the lipoglycopeptides family, recently approved by FDA for the treatment of ABSSSIs (Acute Bacterial Skin and Skin Structure Infections) and can be considered as a candidate for the treatment of orthopaedic superficial SSIs. An antimicrobial activity directed against MRSA and other multi-resistant Gram-positive pathogens, a bactericidal effect and an extremely extended half-life are among key features of this drug. Dalbavancin gives to clinicians the option to provide an intravenous antimicrobial agent shown to be as effective as conventional therapies, without requiring prolonged admission into the hospital, drastically reducing the length of hospital stay (without reducing the treatment compliance) and total cost per patient. In this paper, we analyze general, microbiological and pharmacological features of dalbavancin, aiming at supporting clinicians while positioning this drug in the context of orthopaedic SSIs.

Monitoring Outcome of Joint Arthroplasty in Italy: Implementation of the National Registry.

Purpose Arthroplasty registries have an important role in improving outcomes in joint surgery. As the demand for joint arthroplasty continues to increase, growing attention is being paid to the establishment of national registries, which contribute to the enhancement of the quality of patients' care. Indeed, providing postmarketing surveillance data in terms of safety and effectiveness of medical devices, registries contribute to the best orthopaedic practice and support public health decision making. In this context, a project aimed at implementing a national arthroplasty registry in Italy has appeared to be essential, and the activities performed in the last years have consolidated data collection of hip and knee replacements. Methods Based on a close cooperation among public health institutions, clinicians, and involved stakeholders, the architecture of the registry is built on three pillars: (1) data collected using Hospital Discharge Records (HDRs) integrated by an additional dataset, (2) implants identified and characterized in a dedicated medical devices library, and (3) a federation of regional registries coordinated by a public health institution, the Italian National Institute of Health. Results Besides the organizational structure, statistical analyses on joint arthroplasty from national HDR database (2001-2014) and Italian registry data (2014) are presented. Currently, the institutions participating in the registry on a voluntary basis show 80% of completeness for hip and 58% for knee, and represent approximately 18% of the national volume. Conclusion To make data collection effective, participation should be mandatory and ruled by a national law. Level of Study Level III, observational analytic study.

[The Italian ArthroPlasty Registry: a model to export?]. / Registro Italiano ArtroProtesi: un modello da esportare?

Medical devices (MD) registries are essentials to evaluate outcomes. They represent a key tool to support market surveillance and vigilance, being critical to identify and characterize the implants, assess their performance and trace patients in case of recall. Therefore, the recent "Proposal for a Regulation of the European Parliament and of the Council on medical devices" asked both the Commission and the Member States to take all appropriate measures to encourage the establishment of registers for specific types of devices, setting common principles to collect comparable information. In Italy more than 170.000 joint replacements were performed in 2013 in over 750 hospitals. Experiences at international level and in some Italian regions show that data from registries are crucial to define the best approach to joint replacement surgery. Results from registries can lead to changes in clinical practice, adopting the best available evidence and avoiding choices associated with poorer outcomes. The Italian Arthroplasty Registry project (RIAP) started in 2006 funded by the DG of Medical Devices and Pharmaceutical Service of the Ministry of Health. Data collection uses Hospital Discharge Records integrated by additional information essential to describe the procedure and identify the implants. As soon as the new European Regulation is approved, a Unique Device Identifier will be assigned to every device. Lacking this information, device identification is currently possible by browsing the RIAP MD Library that includes about 55,000 records and is constantly updated by 60 Manufacturers. The model designed within the RIAP project is simple and might be applied for every implanted device when the additional minimum dataset is defined.