Ten technical aspects of baseplate fixation in reverse total shoulder arthroplasty for patients without glenoid bone loss: a systematic review

The aim of this systematic review was to collect evidence on the following 10 technical aspects of glenoid baseplate fixation in reverse total shoulder arthroplasty (rTSA): screw insertion angles; screw orientation; screw quantity; screw length; screw type; baseplate tilt; baseplate position; baseplate version and rotation; baseplate design; and anatomical safe zones. Five literature libraries were searched for eligible clinical, cadaver, biomechanical, virtual planning, and finite element analysis studies. Studies including patients >16 years old in which at least one of the ten abovementioned technical aspects was assessed were suitable for analysis. We excluded studies of patients with: glenoid bone loss; bony increased offset-reversed shoulder arthroplasty; rTSA with bone grafts; and augmented baseplates. Quality assessment was performed for each included study. Sixty-two studies were included, of which 41 were experimental studies (13 cadaver, 10 virtual planning, 11 biomechanical, and 7 finite element studies) and 21 were clinical studies (12 retrospective cohorts and 9 case-control studies). Overall, the quality of included studies was moderate or high. The majority of studies agreed upon the use of a divergent screw fixation pattern, fixation with four screws (to reduce micromotions), and inferior positioning in neutral or anteversion. A general consensus was not reached on the other technical aspects. Most surgical aspects of baseplate fixation can be decided without affecting fixation strength. There is not a single strategy that provides the best outcome. Therefore, guidelines should cover multiple surgical options that can achieve adequate baseplate fixation

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

: In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing the placing on the market of medical devices is decentralized to independent 'conformity assessment' organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details-which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe

An open comminuted tibia fracture including a 5 cm tibial bone defect in a child: Successful management using a locking compression plate

Traumatic bone defects (TBDs), although rare in children, are severe injuries that often represents a challenge for both orthopaedic and trauma surgeons. We present a case of a 6-year-old girl who sustained an open (Gustilo-Anderson type II) comminuted tibia fracture including a ± 5.0 cm distal tibial TBD following a road traffic accident. Open reduction and internal fixation with a 3.5 Locking Compression Plate (LCP) without additional bone grafting was performed, followed by cast immobilization for four months. One and a half years after reconstruction, the patient regained pain-free activity including full-range of motion of her leg and radiographs showed good tibial and fibular alignment, the presence of fracture consolidation and sufficient filling of the TBD. This case report aims to show first evidence of the safety and efficacy of single LCP plating followed by cast immobilization applied in a paediatric patient with a large tibial TBD

10-Year Outcomes After Left Ventricular Reconstruction: Rethinking the Impact of Mitral Regurgitation

Background: Heart failure with reduced ejection fraction due to a post-infarction anteroseptal aneurysm carries a poor prognosis. Patients with refractory heart failure may be considered for advanced surgery, including left ventricular assist device implantation, heart transplantation and left ventricular reconstruction. The aim of this study was to evaluate outcomes after an integrated approach of left ventricular reconstruction with concomitant procedures (mitral/tricuspid valve repair, coronary revascularization), and assess risk factors for event-free survival, focusing on left ventricular geometry/function and presence of functional mitral regurgitation (MR). Methods: A total of 159 consecutive heart failure patients who underwent left ventricular reconstruction between 2002 and 2011 were included. Mid-term echocardiographic and long-term clinical outcomes were evaluated. Preoperative risk factors were correlated to event-free survival (freedom from mortality, left ventricular assist device implantation, and heart transplantation). Results: Mid-term echocardiography demonstrated decreased indexed left ventricular end-systolic volumes (89 ± 42 mL/m2 preoperatively; 51 ± 18 at mid-term, p < 0.001), and absence of MR ≥ grade 2. Event-free survival was 83% ± 3% at 1-year, 68% ± 4% at 5-year, and 46% ± 4% at 10-year follow-up. Preoperative wall motion score index (WMSI; hazard ratio [HR] 3.1, 95% confidence interval [CI] 1.7–5.8, p < 0.001) and presence of MR ≥ grade 2 (HR 1.9, 95% CI 1.1–3.1, p = 0.014) were independently associated with adverse event-free survival. Conclusions: Event-free survival is favorable in patients with WMSI < 2.5 and significantly worse when WMSI is ≥ 2.5. In both groups, the presence of preoperative MR ≥ grade 2 negatively affects event-free survival, despite successful correction of MR. Risk stratification by preoperative WMSI and MR grade supports the Heart team in choosing the optimal surgical strategy for patients with refractory heart failure

Management of displaced humeral surgical neck fractures in daily clinical practice: hanging does not re-align the fracture

Introduction: It is unclear if the collar and cuff treatment improve alignment in displaced surgical neck fractures of the proximal humerus. Therefore, this study evaluated if the neckshaft angle and extent of displacement would improve between trauma and onset of radiographically visible callus in non-operatively treated surgical neck fractures (Boileau type A, B, C). Materials and Methods: A consecutive series of patients (≥ 18 years old) were retrospectively evaluated from a level 1 trauma center in Australia (inclusion period: 2016–2020) and a level 2 trauma center in the Netherlands (inclusion period: 2004 to 2018). Patients were included if they sustained a Boileau-type fracture and underwent initial non-operative treatment. The first radiograph had to be obtained within 24 h after the initial injury and the follow-up radiograph(s) 1 week after trauma and before the start of radiographically visible callus. On each radiograph, the maximal medial gap (MMG), maximal lateral gap (MLG), and neck-shaft angle (NSA) were measured. Linear mixed modelling was performed to evaluate if these measurements would improve over time. Results: Sixty-seven patients were included: 25 type A, 11 type B, and 31 type C fractures. The mean age (range) was 68 years (24–93), and the mean number (range) of follow-up radiographs per patient was 1 (1–4). Linear mixed modelling on both MMG and MLG revealed no improvement during follow-up among the three groups. Mean NSA of type A fractures improved significantly from 161° at trauma to 152° at last follow-up (p-value = 0.004). Conclusions: Apart from humeral head angulation improvement in type A, there is no increase nor reduction in displacement among the three fracture patterns. Therefore, it is advised that surgical decision-making should be performed immediately after trauma. Level of clinical evidence: Level IV, retrospective case series.Biomechanical Engineerin

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle : A Systematic Review

Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformite Europeenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. Methods: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. Results: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. Conclusion: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes