Outcome after total ankle replacement or ankle arthrodesis in end-stage ankle osteoarthritis on the basis of german-wide data: a retrospective comparative study over 10 years.

BACKGROUND: In symptomatic end-stage osteoarthritis of the ankle joint, total ankle replacement and ankle arthrodesis are the two primary surgical options for patients for whom conservative treatment fails. Published revision rates are often biased and difficult to compare. In this study, unplanned reoperation rates and revision rates were determined for both surgical interventions based on a large dataset, and risk factors for unplanned reoperations were identified. METHODS: German-wide health data of the largest German health-care insurance carrier between 2001 and 2012 were retrospectively analyzed, and unplanned reoperation rates within 10 years were determined for index surgeries conducted in 2001 and 2002. Unplanned reoperation rates within 5 years for index surgeries conducted in 2001/2002 were compared to index surgeries conducted in 2006/2007. Multivariate logistic regression was used to identify risk factors for unplanned reoperations. RESULTS: After ankle arthrodesis, 19% (95% confidence interval [CI], 16-22%) of 741 patients needed to undergo an unplanned reoperation within ten years. After total ankle replacement, the unplanned reoperation rate was 38% [95% CI, 29-48%] among 172 patients. For initial surgeries conducted at a later date, unplanned reoperation rates within five years were 21% [95% CI, 19-24%] for 1,168 ankle arthrodesis patients and 23% [95% CI, 19-28%] for 561 total ankle replacement patients. Significant risk factors for unplanned reoperations after ankle arthrodesis in the initial cohort were age < 50 years (odds ratio [OR] = 4.65 [95% CI 1.10;19.56]) and osteoporosis (OR = 3.72 [95% CI, 1.06;13.11]); after total ankle replacement, they were osteoporosis (OR = 2.96 [95% CI, 1.65;5.31]), Patient Clinical Complexity Level (PCCL) grade 3 (OR = 2.19 [95% CI, 1.19;4.03]), PCCL grade 4 (OR = 2.51 [95% CI, 1.22;5.17]) and diabetes mellitus (OR = 2.48 [95% CI, 1.33;4.66]). Kaplan-Meier analyses including 1,525 ankle arthrodesis patients and 644 total ankle replacement patients revealed an average unplanned reoperation-free time of approximately 17 years for both procedures. CONCLUSIONS: Similar revision rates and unplanned reoperation rates for both procedures in the later-date cohort can likely be attributed to a learning curve for surgeons as well as advances in implant design. This analysis of billing health insurance data supports an increase in total ankle replacement surgeries.

[Routine Practice Data for Health Care Analyses: Part 3 of the Manual]. / Versorgungsnahe Daten für Versorgungsanalysen ­ Teil 3 des Manuals.

Analyses of health and health care (hereafter referred to as "health care analyses") usually aim to make transparent the structures, processes, results and interrelationships of health care and to record the degree to which health care systems and their actors have achieved their goals. Health care-related data are an indispensable source of data for many health care analyses. A prerequisite for the examination of a degree of goal achievement is first of all an agreement on those goals that are to be achieved by the system and its substructures, as well as the identification of the determinants of the achievement of the objectives. Primarily it must be examined how safely, effectively and patient-centred systems, facilities and service providers are operating. It also addresses issues of need, accessibility, utilisation, timeliness, appropriateness, patient safety, coordination, continuity, and health economic efficiency and equity of health care. The results of health care include system services (outputs), on the one hand, and results (outcomes), on the other, whereby the results (patient-reported outcomes) and experiences (patient-reported experiences) reported are of particular importance. Health care analyses answer basic questions of health care research: who does what, when, how, why and with which resources and effects in routine health care. Health care analyses thus provide the necessary findings and key figures to further develop health care in order to improve the quality of health care. The applications range from capacity analyses to following innovations up to the concept of regional and supra-regional monitoring of the quality of care given to the population. Given the progress of digitalisation in Health Care, direct data from the care processes will be increasingly available for health care research. This can support care givers significantly if the findings of the studies are applied precisely and correctly within an adequate methodological frame. This can lead to measurable improved health care quality for patients. Data from the process of health care provision have a high potential. Their use needs the same scientific scrutiny as in all other scientific studies.

Intraoperative damage to surgical gloves during various operations on the musculoskeletal system: a multicenter study.

INTRODUCTION: Various orthopedic surgical procedures cause mechanical stress for gloves. In some cases, sharp-edged objects impact on the glove surfaces. The systematic description of lesions is still missing. METHODS: 2289 gloves from 409 surgeries [primary hip and knee arthroplasties (PA), revisions arthroplasties (RA) and arthroscopic shoulder, hip and knee surgery (AY)] from 3 clinics were examined for lesions using water tightening test according to the European norm EN 455-1. RESULTS: Arthroscopies showed the lowest rate of operations with damaged gloves (6.9%). Depending on clinic, 32.7% and 59.2% of PA surgeries generated damaged gloves, while in RA, these numbers rose to 76.0% and 72.8%, respectively. In PA and RA, the most affected finger was the index finger, whereas in arthroscopies, more damage occurred on the middle finger and the thumb. The size of the lesions was rather small with the vast majority being 1 mm or 2 mm in size. CONCLUSION: All investigated interventions led to glove lesions. With increasing mechanical stress, the number of glove defects increased. EN 455 does not account for the intraoperative tear risk. Stricter requirements for gloves should be introduced. Glove change intervals should be defined and implemented, and new materials should be developed.

[Position paper of the German Network for Health Services Research (DNVF) on application-related data collection according to Social Code Book V]. / Positionspapier des Deutschen Netzwerk Versorgungsforschung (DNVF) zur anwendungsbegleitenden Datenerhebung nach Sozialgesetzbuch V.

Within the framework of the early benefit assessment, the Federal Joint Committee (G-BA) has been authorised since 2019 by the law for more safety in the supply of pharmaceuticals GSAV to request additional application-related data capture for certain pharmaceutical drugs. This results in certain challenges, especially in the area of conflict between methodological requirements and practical feasibility. The position paper provides an overview and takes up the general regulations defined by the Federal Ministry of Health (BMG) as well as the process defined by the G-BA. Subsequently, possible solutions are discussed and recommendations for implementation are given from the perspective of health care research.

[Routine Practice Data for Evaluating Intervention Effects: Part 2 of the Manual]. / Versorgungsnahe Daten zur Evaluation von Interventionseffekten: Teil 2 des Manuals.

The evaluation of intervention effects is an important domain of health services research. The ad hoc commission for the use of routine practice data of the German Network for Health Services Research (DNVF) therefore provides this second part of its manual focusing on the use of routine practice data for the evaluation of intervention effects. First, we discuss definition issues and the importance of contextual factors. Subsequently, general requirements for planning, data collection and analysis as well as concrete examples for the evaluation of intervention effects for the 3 fields of application regarding pharmacotherapy, nonpharmaceutical interventions as well as complex interventions are elaborated. We consider scenarios in which no information from randomized controlled trials (RCTs) comparing the two groups directly is yet available or in which RCTs are already available but an extension of the research question is required. In all examples either with or without randomization, the first and foremost question is always whether the data source is suitable for the specific research question. Most of the examples chosen are from oncology trials, because the necessary data are already available for Germany, at least in some form. Finally, the manual discusses possible challenges for future use of these data.

[Memorandum Registry for Health Services Research: Update 2019]. / Memorandum Register für die Versorgungsforschung: Update 2019.

Health registries could be used to analyze questions concerning routine practice in healthcare. Therefore, registries are a core method in health services research. The German Network for Health Services Research (Deutsches Netzwerk Versorgungsforschung, DNVF) promotes the quality of registries by scientific exchange, organization of advanced training, and recommendations in the form of a memorandum "Registry for Health Services Research". The current recommendations are an update of the memorandum's first version of 2010. The update describes the capabilities and aims of registries in health services research. Furthermore, it illustrates the state-of-the-art in designing and implementing health registries. The memorandum provides developers the methodological basis to ensure high quality health registries. It further provides users of health registries with insights that enable assessing the quality of data and results of health registries. Finally, funding agencies and health policy actors can use the quality criteria to establish a framework for the financing and legislative requirements for health registries. The memorandum provides first a definition of health registries and presents an overview of their utility in health services research and health care improvement. Second, several areas of methodological importance for the development and operation of health registries are presented. This includes the conceptual and preliminary design, implementation, technical organization of a health registry, statistical analysis, reporting of results, and data protection. From these areas, criteria are deduced to allow the assessment of the quality of a health registry. Finally, a checklist is presented.

[Manual for Methods and Use of Routine Practice Data for Knowledge Generation]. / Manual für Methoden und Nutzung versorgungsnaher Daten zur Wissensgenerierung.

" There are more and more good reasons for using existing care data, with the focus in particular on the use of register data. The associated, clearly structured methodological procedure has so far been insufficiently combined, prepared and presented transparently. The German Network for Health Services Research (DNVF) has therefore set up an ad hoc commission for the use of routine practice data (RWE/RWD). The rapid report prepared by IQWiG on the scientific development of concepts for "generation of care-related data and their evaluation for the purpose of benefit assessment of medicinal products according to § 35a SGB V" is an essential step for the use of register data for the generation of evidence. The "Memorandum Register - Update 2019" published by DNVF 2020 also describes the requirements and methodological foundations of registers. Best practice examples from oncology, which are based on the uniform oncological basic data set for clinical cancer registration (§ 65c SGB V), show, for example, that guidelines can be checked and recommendations for guidelines and necessary interventions can be derived in the sense of knowledge-generating health services research using register data. At the same time, however, there are no clear quality requirements and structured formal and content-related procedures in the areas of data consolidation, data verification and the use of specific methods depending on the question at hand. The previously inconsistent requirements are to be revised and a method guide for the use of suited data is to be developed and published. The first chapter of the manual on methods of care-related data explains the objective and structure of the manual. It explains why the use of the term "routine practice data" is more effective than the use of the terms Real Word Data (RWD) and Real World Evidence (RWE). By avoiding the term "real world" it should be emphasized in particular that high-quality research can also be based on routine practice data (e. g. register-based comparative studies).

[DNVF-Memorandum III - Methods for Health Services Research, Part 4 - Concept and Methods for Organizational Health Services Research. Chapter 2 - Methodological Approaches for Organizational Health Services Research: Measures, Data Sources, Data Collection and Data Analysis]. / DNVF-Memorandum III ­ Methoden für die Versorgungsforschung, Teil 4 ­ Konzept und Methoden der organisationsbezogenen Versorgungsforschung. Kapitel 2 ­ Methodische Ansätze der organisationsbezogenen Versorgungsforschung: Zielgrößen, Datenquellen, Datenerhebung und Datenanalyse.

Organizational health services research is still a relatively young field of research in Germany which is of increasing interest. The German Network Health Services Research e.V. (DNVF e.V.) published in 2009 - supported by expert associations and individual members of the DNVF - a guide on "Methods for organizational health services research" of the Memorandum III, part 1 1. Originating from this publication and facilitated by the increasing relevance of the field, a necessity to refine the conceptual and methodological basis became evident. The update and extension of the publication from 2009 consists of 3 chapters: (1) Definition and concept of organizational health services research, (2) Methodological approaches in organizational health services research: indicators, data sources, data collection and data analysis, (3) Methodological approaches for the design, evaluation and implementation of complex interventions in healthcare organizations. The aim of the second chapter is to derive methodological requirements and characteristics of organizational health services research - based on the unique characteristics of the research field presented in chapter 1.

[DNVF-Memorandum III - Methods for Health Services Research, Part 4 - Concept and Methods for Organizational Health Services Research: Short Version]. / DNVF-Memorandum III ­ Methoden für die Versorgungsforschung, Teil 4 ­ Konzept und Methoden der organisationsbezogenen Versorgungsforschung: Kurzfassung.

Organizational health services research in Germany is of increasing relevance. Based on the guide on methods for organizational health services research of the Memorandum III, part 1 from the year 2009, the fundamentals and standards have now been refined. The memorandum captures the theoretical framework, basic methodological approaches and methods in health services research for the design, evaluation and implementation of complex interventions in healthcare organizations.

Advances in biology and mechanics of rotator cuff repair.

UNLABELLED: High initial fixation strength, mechanical stability and biological healing of the tendon-to-bone interface are the main goals after rotator cuff repair surgery. Advances in the understanding of rotator cuff biology and biomechanics as well as improvements in surgical techniques have led to the development of new strategies that may allow a tendon-to-bone interface healing process, rather than the formation of a fibrovascular scar tissue. Although single-row repair remains the most cost-effective technique to address a rotator cuff tear, some biological intervention has been recently introduced to improve tissue healing and clinical outcome of rotator cuff repair. Animal models are critical to ensure safety and efficacy of new treatment strategies; however, although rat shoulders as well as sheep and goats are considered the most appropriate models for studying rotator cuff pathology, no one of them can fully reproduce the human condition. Emerging therapies involve growth factors, stem cells and tissue engineering. Experimental application of growth factors and platelet-rich plasma demonstrated promising results, but has not yet been transferred into standardized clinical practice. Although preclinical animal studies showed promising results on the efficacy of enhanced biological approaches, application of these techniques in human rotator cuff repairs is still very limited. Randomized controlled clinical trials and post-marketing surveillance are needed to clearly prove the clinical efficacy and define proper indications for the use of combined biological approaches. The following review article outlines the state of the art of rotator cuff repair and the use of growth factors, scaffolds and stem cells therapy, providing future directions to improve tendon healing after rotator cuff repair. LEVEL OF EVIDENCE: Expert opinion, Level V.

Midterm Outcome after Mega-Prosthesis Implanted in Patients with Bony Defects in Cases of Revision Compared to Patients with Malignant Tumors.

Use of mega-prostheses is a common option for the treatment of patients with malignant tumors as well as in patients with large osseous defects at the time of revision surgery. No studies have compared the two groups to determine whether there is a relative difference in clinical outcomes. We performed a midterm-outcome-study to evaluate our results in these two patient populations. Deep infection was found more often in our revision group (29.5% vs. 9.1%), however no significant differences in WOMAC-results could be found between the two groups. Surgeons should recognize the high complication rate as well as the differences in results using mega-prostheses in these two distinct groups of patients.

Analysis of agreement between the German translation of the American Foot and Ankle Society's Ankle and Hindfoot Scale (AOFAS-AHS) and the Foot Function Index in its validated German translation by Naal et al. (FFI-D).

BACKGROUND: Despite its wide use in clinical outcome measurement, there is yet no validated German language version of the AOFAS-AHS available. After finishing cross-cultural adaption of the AOFAS-AHS according to the AAOS guidelines, an analysis of agreement was carried out. METHODS: This was done by means of the 18-item Foot Function Index in its validated German translation by Naal et al. (FFI-D). The results of 91 orthopedic patients as well as healthy persons in both scores were then compared intraindividually. The cohort consisted of 46 individuals with hindfoot disorders and 45 persons without any hindfoot complaints. The FFI-D-Score was linearly transformed in the range 0-100 points of the AOFAS. RESULTS: Encouraging correlation was then found for the patients with hindfoot disorders (Spearman's correlation 0.73 (95% CI 0.52-0.85); a median deviation of -2 points (interquartile range -13 points; +13 points) in patients with hindfoot disorders implied good median intraindividual score concordance. However, with 30 of these 46 patients showing score deviations beyond or below a pre-specified ±10 points range of clinically tolerable deviations, the scores cannot be considered exchangeable. CONCLUSION: Although the agreement analysis was performed for the German translation of the two questionnaires, analogous results can be expected also for other languages. It should be noted that the results do not allow for judging which of the scores is better suited to give a valid statement on patient outcome in treatment of hindfoot disorders. To verify which of these two scores is better suited to represent hindfoot-dysfunction a subsequent study using instrumental gait analysis and surface EMG is being carried out.

[The German Association for Foot and Ankle (D.A.F.) registry on treatment of end-stage total ankle arthritis-what is its clinical impact?] / Das Sprunggelenkregister der Deutschen Assoziation für Fuß- und Sprunggelenk e. V. (D.A.F.) zur Behandlung der fortgeschrittenen Sprunggelenkarthrose ­ wo liegt der klinische Nutzen?

Initially established as a voluntary prosthesis register for total ankle replacement, the registry now enables analysis of revisions, complications, and clinical and functional outcomes-including patient-reported outcome measures-based on a period spanning more than 10 years. To allow analyses of the outcomes of ankle arthrodesis and supramalleolar osteotomies for treatment of end-stage arthritis in the future, the registry was extended by structured capturing of these procedures in 2018. While descriptive and analytical statistical evaluations of total ankle replacement are already possible today, the number of datasets on arthrodesis and supramalleolar osteotomies is still too small to support these analyses or comparative evaluations.

Using the Oxford Foot Model to determine the association between objective measures of foot function and results of the AOFAS Ankle-Hindfoot Scale and the Foot Function Index: a prospective gait analysis study in Germany.

OBJECTIVE: After cross-cultural adaption for the German translation of the Ankle-Hindfoot Scale of the American Orthopaedic Foot and Ankle Society (AOFAS-AHS) and agreement analysis with the Foot Function Index (FFI-D), the following gait analysis study using the Oxford Foot Model (OFM) was carried out to show which of the two scores better correlates with objective gait dysfunction. DESIGN AND PARTICIPANTS: Results of the AOFAS-AHS and FFI-D, as well as data from three-dimensional gait analysis were collected from 20 patients with mild to severe ankle and hindfoot pathologies.Kinematic and kinetic gait data were correlated with the results of the total AOFAS scale and FFI-D as well as the results of those items representing hindfoot function in the AOFAS-AHS assessment. With respect to the foot disorders in our patients (osteoarthritis and prearthritic conditions), we correlated the total range of motion (ROM) in the ankle and subtalar joints as identified by the OFM with values identified during clinical examination 'translated' into score values. Furthermore, reduced walking speed, reduced step length and reduced maximum ankle power generation during push-off were taken into account and correlated to gait abnormalities described in the scores. An analysis of correlations with CIs between the FFI-D and the AOFAS-AHS items and the gait parameters was performed by means of the Jonckheere-Terpstra test; furthermore, exploratory factor analysis was applied to identify common information structures and thereby redundancy in the FFI-D and the AOFAS-AHS items. RESULTS: Objective findings for hindfoot disorders, namely a reduced ROM, in the ankle and subtalar joints, respectively, as well as reduced ankle power generation during push-off, showed a better correlation with the AOFAS-AHS total score-as well as AOFAS-AHS items representing ROM in the ankle, subtalar joints and gait function-compared with the FFI-D score.Factor analysis, however, could not identify FFI-D items consistently related to these three indicator parameters (pain, disability and function) found in the AOFAS-AHS. Furthermore, factor analysis did not support stratification of the FFI-D into two subscales. CONCLUSIONS: The AOFAS-AHS showed a good agreement with objective gait parameters and is therefore better suited to evaluate disability and functional limitations of patients suffering from foot and ankle pathologies compared with the FFI-D.

Pilot study for the registry of complications in rheumatic diseases from the German Society of Surgery (DGORh): evaluation of methods and data from the first 1000 patients.

OBJECTIVE: Most patients suffering with rheumatic diseases who undergo surgical treatment are receiving immune-modulating therapy. To determine whether these medications affect their outcomes a national registry was established in Germany by the German Society of Surgery (DGORh). Data from the first 1000 patients were used in a pilot study to identify relevant corisk factors and to determine whether such a registry is suitable for developing accurate and relevant recommendations. DESIGN AND PARTICIPANTS: Data were collected from patients undergoing surgical treatments with their written consent. A second consent form was used, if complications occurred. During this pilot study, in order to obtain a quicker overview, risk factors were considered only in patients with complications. Only descriptive statistical analysis was employed in this pilot study due to limited number of observed complications and inhomogeneous data regarding the surgery and the medications the patients received. Analytical statistics will be performed to confirm the results in a future outcome study. RESULTS: Complications occurred in 26 patients and were distributed equally among the different types of surgeries. Twenty one of these patients were receiving immune-modulating therapy at the time, while five were not. Infections were observed in 2.3% of patients receiving and in 5.1% not receiving immunosuppression. CONCLUSIONS: Due to the low number of cases, inhomogeneity in the diseases and the treatments received by the patients in this pilot study, it is not possible to develop standardised best-practice recommendations to optimise their care. Based on this observation we conclude that in order to be suitable to develop accurate and relevant recommendations a national registry must include the most important and relevant variables that impact the care and outcomes of these patients.

Cartilage repair techniques of the talus: An update.

Symptomatic chondral or osteochondral defects of the talus reduce the quality of life of many patients. Although their pathomechanism is well understood, it is well known that different aetiologic factors play a role in their origin. Additionally, it is well recognised that the talar articular cartilage strongly differs from that in the knee. Despite this fact, many recommendations for the management of talar cartilage defects are based on approaches that were developed for the knee. Conservative treatment seems to work best in paediatric and adolescent patients with osteochondritis dissecans. However, depending on the size of the lesions, surgical approaches are necessary to treat many of these defects. Bone marrow stimulation techniques may achieve good results in small lesions. Large lesions may be treated by open procedures such as osteochondral autograft transfer or allograft transplantation. Autologous chondrocyte transplantation, as a restorative procedure, is well investigated in the knee and has been applied in the talus with increasing popularity and promising results but the evidence to date is poor. The goals of the current article are to summarise the different options for treating chondral and osteochondral defects of the talus and review the available literature.