Influence of surgical approach on functional outcome in reverse shoulder arthroplasty

SummaryIntroductionReverse shoulder arthroplasties (RSA) can be performed using a Deltopectoral (DP) or alternatively a Transdeltoid (TD) approach.HypothesisAlthough the humeral cut is lower by TD approach, this should not affect postoperative functional results.Material and methodsThis retrospective multicentric study evaluated the complete medical records of RSA implanted between October 2003 and December 2008. Inclusion criteria were: follow-up of at least 1year, a complete file including a comparative radiological work-up making it possible to analyze eventual arm and humeral lengthening. Evaluation of postoperative function was based on Active Anterior Elevation (AAE).ResultsWe studied 144 RSA in 142 patients. One hundred and nine RSA were implanted by the DP approach and 35 by the TD approach. Mean lengthening of the humerus compared to the controlateral side by DP approach was 0.5±1.3cm while there was a mean shortening of −0.5±1.0cm by TD approach (P<0.001). The difference in cut was partially compensated by using thicker polyethylene inserts with the TD approach. Mean arm lengthening compared to the controlateral side was 1.7±1.7cm by DP approach and 1.2±1.4cm by TD approach (mean difference 0.5cm; (95% CI −0.1; 1.2). AAE for RSA by DP approach was 145±22° and 135±29° by TD approach (mean difference 10°, 95% CI −1; 21).DiscussionRSA results in improved AAE because of restored deltoid tension and an increase in the deltoid lever arm. The humeral cut by TD is lower, but this was partially corrected in this study by the use of thicker polyethylene inserts. Nevertheless there is no significant clinical difference in postoperative function between the two approaches.Level of EvidenceLevel IV. Retrospective therapeutic study

MoM total hip replacements in Europe: a NORE report

The purpose of this paper is to determine the prevalence of metal-on-metal (MoM) total hip replacement (THR) in European registries, to assess the incidence of revision surgery and to describe the national follow-up guidelines for patients with MoM THR including resurfacings.Eleven registries of the Network of Orthopaedic Registries of Europe (NORE) participated totalling 54 434 resurfacings and 58 498 large stemmed MoM THRs.The resurfacings and stemmed large head MoM had higher pooled revision rates at five years than the standard total hip arthroplasties (THA): 6.0%, 95% confidence interval (CI) 5.3 to 6.8 for resurfacings; 6.9%, 95% CI 4.4 to 9.4 for stemmed large head MoM; and 3.0%, 95% CI 2.5 to 3.6 for conventional THA.The resurfacings and stemmed large head MoM had higher pooled revision rates at ten years than the standard THAs: 12.1%, 95% CI 11.0 to 13.3 for resurfacings; 15.5%, 95% CI 9.0 to 22 for stemmed large head MoM; and 5.1%, 95% CI 3.8 to 6.4 for conventional THA.Although every national registry reports slightly different protocols for follow-up, these mostly consist of annual assessments of cobalt and chromium levels in blood and MRI (MARS) imaging

Obesity in total hip arthroplasty—does it really matter?: A meta-analysis

Discussion persists as to whether obesity negatively influences the outcome of hip arthroplasty. We performed a meta-analysis with the primary research question of whether obesity has a negative effect on short- and long-term outcome of total hip arthroplasty. We searched the literature and included studies comparing the outcome of hip arthroplasty in different weight groups. The methodology of the studies included was scored according to the Cochrane guidelines. We extracted and pooled the data. For continuous data, we calculated a weighted mean difference and for dichotomous variables we calculated a weighted odds ratio (OR). Heterogeneity was calculated using I(2) statistics. 15 studies were eligible for data extraction. In obese patients, dislocation of the hip (OR = 0.54, 95% CI: 0.38-0.75) (10 studies, n = 8,634), aseptic loosening (OR = 0.64, CI: 0.43-0.96) (6 studies, n = 5,137), infection (OR = 0.3, CI: 0.19-0.49) (10 studies, n = 7,500), and venous thromboembolism (OR = 0.56, CI: 0.32-0.98) (7 studies, n = 3,716) occurred more often. Concerning septic loosening and intraoperative fractures, no statistically significant differences were found, possibly due to low power. Subjective outcome measurements did not allow pooling because of high heterogeneity (I(2) = 68%). Obesity appears to have a negative influence on the outcome of total hip replacemen

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

Increased Mortality in Metal-on-Metal versus Non-Metal-on-Metal Primary Total Hip Arthroplasty at 10 Years and Longer Follow-Up: A Systematic Review and Meta-Analysis

Analysis and Stochastic