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• This systematic review and meta-analysis aimed to analyse negative effects of smoking in orthopaedic and trauma patients.

• A PubMed search was carried out for studies published until July 2020 regarding effects of smoking on fracture risk, nonunion, infection after orthopaedic surgery, and persisting nonunion after scaphoid nonunion surgery. Random effects models calculated for outcome parameters, and relative risks (RR) with 95% confidence intervals are provided. No adjustments for covariates were made. Heterogeneity was assessed with Higgins’ I2, publication bias with Harbord’s p (Hp), sensitivity analysis performed on funnel plots and quality of studies was analysed using the Newcastle-Ottawa Scale.

• Of 3362 retrieved entries, 69 were included in the final analysis. Unadjusted RR for smokers to develop vertebral (six studies, seven entries; RR: 1.61; p = 0.008; I2 = 89.4%), hip (11 studies, 15 entries; RR: 1.28; p = 0.007; I2 = 84.1%), and other fractures (eight studies, 10 entries; RR: 1.75; p = 0.019; I2 = 89.3%) was significantly higher. Postoperative infection risk was generally higher for smokers (21 studies; RR: 2.20; p < 0.001; I2 = 58.9%), and remained upon subgroup analysis for elective spinal (two studies; RR: 4.38; p < 0.001; I2 = 0.0%) and fracture surgery (19 studies; RR: 2.10; p < 0.001; I2 = 58.5%). Nonunion risk after orthopaedic (eight studies; RR: 2.15; p < 0.001; I2 = 35.9%) and fracture surgery (11 studies; RR: 1.85; p < 0.001; I2 = 39.9%) was significantly higher for smokers, as was persisting nonunion risk after surgery for scaphoid nonunion (five studies; RR: 3.52; p < 0.001; I2 = 0.0%). Sensitivity analysis for each model reduced heterogeneity whilst maintaining significance (all I2 < 20.0%).

• Smoking has a deleterious impact on fracture incidence, and (subsequent) development of nonunions and postoperative infections.

Cite this article: EFORT Open Rev 2021;6:1006-1019. DOI: 10.1302/2058-5241.6.210058

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, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity assessment’ organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, 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.

Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302/2058-5241.6.210081

• Approximately 60,000 cemented femoral stems are implanted in the UK each year with the majority being manufactured from stainless steel containing 10–15% nickel. Nickel hypersensitivity has been reported in up to 13% of the general population and there is a concern that nickel hypersensitivity might adversely affect the outcome of total hip replacement (THR). We reviewed the current literature on the potential link between nickel hypersensitivity and THR complications, and the usefulness of patch testing.

• We conducted a literature search in PubMed, MEDLINE and EMBASE databases. The level of evidence and the quality of the selected studies were assessed using the Oxford Centre for Evidence-Based Medicine Criteria and the Methodological Index for Non-Randomised Studies tool, respectively.

• Twenty-six studies met the inclusion criteria, reporting on 1852 patients who underwent primary or revision THR. All studies detailed skin patch testing and recorded prevalence of nickel hypersensitivity from 1.5% to 33.3%. Five studies reported a rise in Nickel hypersensitivity following THR, while four reported a decreased prevalence post-operatively. Eight studies concluded that metal hypersensitivity could have developed following THR, while seven studies did not support a link between metal hypersensitivity and THR complications. Four of the studies recommended routine patch testing pre-operatively, but three others concluded that routine patch testing was not indicated.

• We have not identified a link between nickel hypersensitivity and THR complications, and the role of patch testing remains unclear. Further large-scale studies would be required to investigate this relationship and to clarify the role of patch testing in facilitating implant selection.

Cite this article: EFORT Open Rev 2021;6:825-838. DOI: 10.1302/2058-5241.6.210051

• Osteoarthritis (OA) is a global health issue with myriad pathophysiological factors and is one of the most common causes of chronic disability in adults due to pain and altered joint function.

• The end stage of OA develops from a destructive inflammatory cycle, driven by the pro-inflammatory cytokines interleukin-1β (IL-1β) and tumour necrosis factor alpha (TNFα).

• Owing to the less predictable results of total knee arthroplasty (TKA) in younger patients presenting with knee OA, there has been a surge in research evaluating less invasive biological treatment options, one of which is autologous protein solution (APS).

• APS is an autologous blood derivative obtained by using a proprietary device, made of APS separator, which isolates white blood cells (WBCs) and platelets in a small volume of plasma, and APS concentrator, which further concentrates platelets, WBCs and plasma proteins, resulting in a concentrated solution with high levels of growth factors including the anti-inflammatory mediators against IL-1β and TNFα.

• A single intraarticular injection of APS appears to be a promising solution for treatment of early-stage OA from current evidence, the majority of which comes from preclinical studies.

• More clinical studies are needed before APS can be widely accepted as a treatment modality for OA.

Cite this article: EFORT Open Rev 2021;6:716-726. DOI: 10.1302/2058-5241.6.200040

• Osteomyelitis refers to an inflammatory process causing bone destruction and necrosis. Managing such a persistent disease is complex, with a number of authors reporting different techniques. This scoping review aims to map and summarize the literature on treatment of chronic femoral and tibial osteomyelitis, in order to improve the reader’s understanding of potential treatments and identify areas of further research.

• The methodological framework of the Joanna Briggs Institute was followed. A computer-based search was conducted in PubMed, EMBASE, MEDLINE, EMCARE and CINAHL, for articles reporting treatment of chronic tibial/femoral osteomyelitis. Two reviewers independently performed title/abstract and full-text screening according to pre-defined criteria.

• A total of 1230 articles were identified, with 40 finally included. A range of treatments are reported, with the core principles being removal of infected tissue, dead-space management and antibiotic therapy. The majority (84.5%) of patients presented with stage III or IV disease according to the Cierny–Mader classification, and Staphylococcus aureus was the most commonly isolated organism. The proportion of patients achieving remission with no recurrence during follow-up varies from 67.7–100.0%.

• The majority of studies report excellent outcomes in terms of infection remission and lack of recurrence. However, identifying specific patient or treatment-related factors which may affect outcomes is currently challenging due to the nature of the included studies and unclear reporting of treatment outcomes. It is now important to address this issue and identify such factors using further high-level research methods such as randomized controlled trials and comparative cohort studies.

Cite this article: EFORT Open Rev 2021;6:704-715. DOI: 10.1302/2058-5241.6.200136

• DAIR (debridement, antibiotics, and implant retention), one-stage and two-stage revision surgery are the most common management strategies for prosthetic joint infection (PJI) management. Our knowledge concerning their efficacy is based on short to medium-term low-quality studies.

• Most studies report infection recurrence rates or infection-free time intervals. However, long-term survival rates of the infection-free joints, functional and quality of life outcome data are of paramount importance.

• DAIR, one-stage and two-stage revision strategies are not unique surgical techniques, presenting several variables. Infection control rates for the above strategies vary from 75% to 90%, but comparisons are difficult because different indications and patient selection criteria are used in each strategy.

• Recent outcome data show that DAIR and one-stage revision in selected patients (based on host, bacteriological, soft tissue and type of infection criteria) may present improved functional and quality of life outcomes and reduced costs for health systems as compared to those of two-stage revision.

• It is expected that health system administrators and providers will apply pressure on surgeons and departments towards the wider use of DAIR and one-stage revision strategies. It is the orthopaedic surgeon’s responsibility to conduct quality studies in order to fully clarify the indications and outcomes of the different revision strategies.

Cite this article: EFORT Open Rev 2021;6:727-734. DOI: 10.1302/2058-5241.6.210008

• Comorbidity indices currently used to estimate negative postoperative outcomes in orthopaedic surgery were originally developed among non-orthopaedic patient populations.

• While current indices were initially intended to predict short-term mortality, they have since been used for other purposes as well.

• As the rate of hip and knee arthroplasty steadily rises, understanding the magnitude of the effect of comorbid disease on postoperative outcomes has become increasingly more important.

• Currently, the ASA classification is the most commonly used comorbidity measure and is systematically recorded by the majority of national arthroplasty registries.

• Consideration should be given to developing an updated, standardized approach for comorbidity assessment and reporting in orthopaedic surgery, especially within the setting of elective hip and knee arthroplasty.

Cite this article: EFORT Open Rev 2021;6:629-640. DOI: 10.1302/2058-5241.6.200124

• Patients with end-stage renal disease (ESRD) have inferior outcomes after hip and knee total joint arthroplasty (TJA), with higher risk for surgical site complications (SSC) and periprosthetic joint infection (PJI).

• We conducted a systematic review and meta-analysis regarding outcomes after hip and knee TJA in ESRD patients who have received dialysis or a kidney transplant (KT) using PubMed, MEDLINE, Cochrane Reviews, and Embase in order to: (1) determine the mortality and infection rate of TJA in patients receiving dialysis or KT and (2) to identify risk factors associated with the outcome.

• We included 22 studies and 9384 patients (dialysis, n = 8921, KT, n = 463). The overall mortality rate was 14.9% and was slightly higher in KT patients (dialysis vs. KT, 13.8% vs. 15.8%). The overall SSC rate was 3.4%, while dialysis and KT patients each had an incidence of 3.3% and 3.6%, respectively. For PJI, the overall rate was 3.9%, while the incidence for dialysis patients was 4.0% and for KT patients was 3.7%.

• Using multi-regression analysis, age, sex, the type of arthroplasty (knee or hip) performed, and the form of renal replacement therapy (dialysis or KT) were not significant risk factors.

• In patients on dialysis or who had received a KT, TJA is associated with a slight increase in mortality, SSC and PJI rates.

Cite this article: EFORT Open Rev 2021;6:618-628. DOI: 10.1302/2058-5241.6.200116

• Nerves may be inadvertently injured during trauma surgery due to distorted anatomy, traction applied to a limb, soft tissue retraction, by power tools, instrumentation and from compartment syndrome. Elective orthopaedic surgery has additional risks of joint dislocation for arthroplasty surgery, limb lengthening, thermal injury from cement and direct injury from peripheral nerve blocks.

• The true incidence is unknown, and many cases are diagnosed as neurapraxia with the expectation of a full and timely recovery without the need for intervention. The incorrect assignation of a neurapraxia diagnosis may delay treatment for a higher grade of injury and in addition fails to recognize that a diagnosis of neurapraxia should be made with caution and a commitment to regular clinical review. Untreated, a neurapraxia can deteriorate and result in axonopathy. The failure to promptly diagnose such a nerve injury and instigate treatment may result in further deterioration and expose the clinician to medicolegal challenge.

• The focus of this review is to raise awareness of iatrogenic peripheral nerve injuries in orthopaedic limb surgery, the importance of regular clinical examination, the role of investigations, timing and nature of interventions and also to provide a guide to when onward referral to a specialist peripheral nerve injury unit is recommended.

Cite this article: EFORT Open Rev 2021;6:607-617. DOI: 10.1302/2058-5241.6.200123

• The histopathological examination of the periprosthetic soft tissue and bone has contributed to the identification and description of the morphological features of adverse local tissue reactions (ALTR)/adverse reactions to metallic debris (ARMD). The need of a uniform vocabulary for all disciplines involved in the diagnosis and management of ALTR/ARMD and of clarification of the parameters used in the semi-quantitative scoring systems for their classification has been considered a pre-requisite for a meaningful interdisciplinary evaluation.

• This review of key terms used for ALTR/ARMD has resulted in the following outcomes: (a) pseudotumor is a descriptive term for ALTR/ARMD, classifiable in two main types according to its cellular composition defining its clinical course; (b) the substitution of the term metallosis with presence of metallic wear debris, since it cannot be used as a category of implant failure or histological diagnosis; (c) the term aseptic lymphocytic-dominated vasculitis- associated lesion (ALVAL) should be replaced due to the absence of a vasculitis with ALLTR/ALRMD for lymphocytic-predominant and AMLTR/AMRMD for macrophage-predominant reaction.

• This review of the histopathological classifications of ALTR/ARMD has resulted in the following outcomes: (a) distinction between cell death and tissue necrosis; (b) the association of corrosion metallic debris with adverse local lymphocytic reaction and tissue necrosis; (c) the importance of cell and particle debris for the viscosity and density of the lubricating synovial fluid; (d) a consensus classification of lymphocytic infiltrate in soft tissue and bone marrow; (e) evaluation of the macrophage infiltrate in soft tissues and bone marrow; (f) classification of macrophage induced osteolysis/aseptic loosening as a delayed type of ALTR/ARMD; (g) macrophage motility and migration as possible driving factor for osteolysis; (h) usefulness of the histopathological examination for the natural history of the adverse reactions, radiological correlation, post-marketing surveillance, and implant registries.

• The review of key terms used for the description and histopathological classification of ALTR/ARMD has resulted in a comprehensive, new standard for all disciplines involved in their diagnosis, clinical management, and long-term clinical follow-up.

Cite this article: EFORT Open Rev 2021;6:399-419. DOI: 10.1302/2058-5241.6.210013