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Ludwig Maximilians University Munich, Department of Orthopaedic and Trauma Surgery, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany
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Translational Health Sciences, Bristol Medical School, Musculoskeletal Research Unit, University of Bristol, Southmead Hospital, Bristol, UK
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Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina, CIBER-BBN, Madrid, Spain
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Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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The objectives of the 1st EFORT European Consensus on ‘Medical and Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices’ were foremost to focus on patient safety by establishing performance requirements for medical devices.
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The 1st EFORT European Consensus applied an a priori-defined, modified Delphi methodology to produce unbiased, high-quality recommendation statements, confirmed by consensus voting of a European expert panel.
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Intended key outcomes are practical guidelines justified by the current stage of knowledge and based on a broad European Expert Consensus, to maintain innovation and optimisation of orthopaedic devices within the boundaries of MDR 2017/745.
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Twenty-one main research areas of relevance were defined relying on input from the EFORT IPSI WG1 ‘Introduction of Innovation’ recommendations and a related survey.
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A modified Delphi approach with a preparatory literature review and work in small groups were used to prepare answers to the research questions in the form of 32 draft Consensus statements.
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A Consensus Conference in a hybrid format, on-site in the Carl Gustav Carus University of Dresden was organised to further refine the draft statements and define consensus within the complete group of participants by final voting, intended to further quantify expert opinion knowledge.
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The modified Delphi approach provides practical guidelines for hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, patient representatives, Notified Bodies, National Institutes and authorities.
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For the first time, initiated by the EFORT IPSI (WG1 ‘Introduction of Innovation’), knowledge of all related stakeholders was combined in the 1st EFORT European Consensus to develop guidelines and result in a comprehensive set of recommendations.
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Department of Occupational Therapy, Shu-Zen Junior College of Medicine and Management, Kaohsiung City, Taiwan
Department of Biomedical Engineering, I-Shou University, Kaohsiung City, Taiwan
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Department of Pharmacy, School of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan
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Purpose
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Comminuted fractures with poor bone quality in the elderly are associated with poor outcomes. An alternative to open reduction and internal fixation (ORIF) alone, primary or acute total hip arthroplasty (aTHA), allows early mobilization with full weight bearing. In this study, we aim to analyze whether treatment of aTHA with/withtout ORIF (limited ORIF) vs ORIF alone yields better intra-operative results, functional outcomes, and less complications.
Methods
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PubMed, Cochrane, Embase, and Scopus databases were searched in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. Random-effects model and 95% confidence intervals were used. The outcomes of interest were surgery time, blood loss, length of hospital stay, Harris hip score (HHS), 36-Item Short Form Survey (SF-36), complication rate, surgical site infection rate, heterotopic ossification rate, reoperation rate, and mortality rate.
Results
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Ten observational studies with a total of 642 patients (415 ORIF alone and 227 aTHA with/without ORIF) were included in the systematic review. Compared to ORIF alone, aTHA with limited ORIF provided higher HHS (P = 0.029), better physical function (P = 0.008), better physical component summary (P = 0.001), better mental component summary (P = 0.043) in postoperative 1-year SF-36, lesser complication rate (P = 0.001), and lesser reoperation rate (P = 0.000), but however greater bodily pain (P = 0.001) in acetabular fractured elderlies.
Conclusions
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Acute THA with limited ORIF is favorable alternative to ORIF technique alone. It provided better HHS, physical, and mental component summary in SF-36 and yielded lower complication and reoperation rate compare to ORIF alone.
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Purpose
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This is a systematic review and meta(regression) analysis to assess the performance of custom triflange acetabular components (CTAC) in total hip arthroplasty (THA) revision surgery. Implant-related complications, failure rate, functional outcomes and implant and surgical technique-related predictors for outcome were assessed.
Methods
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This systematic review was performed according to PRISMA guidelines and registered with PROSPERO (2020 CRD42020209700). PubMed, Embase, Web of Science, COCHRANE Library and Emcare were searched. Studies on Paprosky type 3A and 3B or AAOS type 3 and 4 acetabular defects with a minimum follow-up of 12 months and cohorts > 10 patients were included.
Results
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Thirty-three studies were eligible for inclusion (n = 1235 hips, 1218 patients). The methodological quality of the studies was moderate (AQUILA: 7.4/11 points). Considerable heterogeneity was observed in terms of complications, re-operations and implant failure reporting. The total incidence of implant-related complications was 24%. The incidence of re-operation for any reason was 15%, and the implant failure rate was 12% at a mean of 46.9 months and the post-operative Harris Hip Score improved by a mean of 40 points. Several predictors for outcome were found, such as implant generation, follow-up length and study start date.
Conclusions
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The use of CTAC in revision THA has satisfactory complication and implant failure rates. The CTAC technique improves post-operative clinical outcomes and the meta-regression analysis showed that there is a clear association between improvements in the CTAC performance and the evolvement of this technique over time.
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Low back pain (LBP) is a common symptom that can occur in all ages. It is the first common cause of disability globally and is associated with over 60 million disability-adjusted life-years in a single year.
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Motor control exercise (MCE) has obtained increasing attention in treating LBP. However, the findings from distinct meta-analyses differed and some even reached controversial conclusions. More importantly, how MCE improves LBP-related symptoms remains unclear.
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The primary aim of this study is to describe the possible improvement mechanisms of MCE on LBP from brain, biochemistry, inflammatory, and neuromuscular aspects. The secondary aim is to further conclude its effectiveness and clinical application. Further understanding of mechanisms and effectiveness could be instructive for future LBP treatments and provide more information for clinicians when making prescriptions.
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MCE is effective in alleviating pain and disability among patients with acute and chronic LBP. Notably, the evidence for acute LBP is relatively low-quality and limited.
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MCE might be more effective for patients with specific LBP characteristics, especially those with pre-diagnosis of impaired transversus abdominis recruitment, intermediate pain intensity, and longer MCE training duration.
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MCE could remap brain representation and reverse negative brain alternation, induce exercise-induced hypoalgesia, mediate anti-inflammatory response, retain normal activation, and improve morphological deficits.
Division of Orthopaedics and Trauma Surgery, Cantonal Hospital Winterthur, Winterthur, Switzerland
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Faculty of Medicine, University of Berne, Berne, Switzerland
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Since the middle of the 20th century, total hip arthroplasty has become a very successful treatment for all end-stage diseases of the hip joint. Charnley solved with his low frictional torque arthroplasty the problem of wear and friction with the introduction of a new bearing couple and the reduction of the head size, which set the prerequisite for the further development of stem design.
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This narrative review presents the major developments of regular straight stems in hip arthroplasty. It does not only provide an overview of the history but also assembles the generally scarce documentation available regarding the rationale of developments and illustrates often-unsuspected links.
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Charnley's success is based on successfully solving the issue of fixation of the prosthetic components to the bone, using bone cement made of polymethyl-methacrylate. In the field of cemented anchorage of the stem, two principles showing good long-term revision rates emerged over the years: the force-closed and the shape-closed principles.
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The non-cemented anchorage bases on prosthesis models ensure enough primary stability for osteointegration of the implant to occur. For bone to grow onto the surface, not only sufficient primary stability is required but also a suitable surface structure together with a biocompatible prosthetic material is also necessary.
Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Department of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany
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Technical University Delft, Delft, the Netherlands
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Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process.
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The EFORT Implant and Patient Safety Initiative WG1 ‘Introduction of Innovation’, combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745.
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Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies.
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Different degrees of novelty and innovation were described and agreed on in relation to when surgeons can start, using implants and implant-related instrumentation routinely.
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Before any clinical phase of a new implant, following the pre-market clinical investigation or the equivalent device PMCF pathway, it is a common understanding that all appropriate pre-clinical testing (regulatory mandatory and evident state of the art) – which has to be considered for a specific device – has been successfully completed.
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Once manufacturers receive the CE mark for a medical device, it can be used in patients routinely when a clinical investigation has been conducted to demonstrate the conformity of devices according to MDR Article 62 or full equivalence for the technical, biological and clinical characteristics has been demonstrated (MDR, Annex XIV, Part A, 3.) and a PMCF study has been initiated.
Hospital Militar de Santiago, Santiago, Chile
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Clínica Alemana - Universidad del Desarrollo, Santiago, Chile
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Lateral hinge fractures (LHF) are one of the most common complications of medial opening wedge high tibial osteotomy (MOWHTO), and are the leading cause of construct instability displacement, non-union, and varus recurrence after this procedure.
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To date, Takeuchi’s classification is the most popular classification to describe this complication, and it can help surgeons to make intra and postoperative decisions.
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Opening medial gap width is the most recognized factor related to LHF occurrence.
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Recognizing the implications of LHF in patients’ clinical and radiographic results has led many authors to propose surgical tips and the use of osteosynthesis materials such as K-wires and screws for its prevention, which should be considered when identifying risk factors for LHF during preoperative planning.
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The evidence for determining the optimal management of LHF is scarce and mostly supported by experts’ opinions and recommendations; therefore, studies are still needed to identify the most appropriate behavior when dealing with such a complication.
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Anticoagulation use is common in elderly patients presenting with hip fractures and has been shown to delay time to surgery (TTS). Delays in operative treatment have been associated with worse outcomes in hip fracture patients. Direct oral anticoagulants (DOACs) comprise a steadily increasing proportion of all oral anticoagulation. Currently, no clear guidelines exist for perioperative management of hip fracture patients taking DOACs.
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DOAC use is associated with increased TTS, with delays frequently greater than 48 h from hospital presentation. Increased mortality has not been widely demonstrated in DOAC patients, despite increased TTS. Timing of surgery was not found to be associated with increased risk of transfusion or bleeding.
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Early surgery appears to be safe in patients taking DOACs presenting with a hip fracture, but is not currently widely accepted due to factors such as site-specific anesthesiologic protocols that periodically delay surgery. Direct oral anticoagulant use should not routinely delay surgical treatment in hip fracture patients.
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Surgical strategies to limit blood loss should be considered and include efficient surgical fixation, topical application of hemostatic agents, and the use of intra-operative cell salvage.
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Anesthesiologic strategies have utility in minimizing risk and a collaborative effort to minimize blood loss should be undertaken by the surgeon and anesthesiologist. Anesthesia team interventions include considerations regarding positioning, regional anesthesia, permissive hypotension, avoidance of hypothermia, judicious administration of blood products, and the use of systemic hemostatic agents.
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Musculoskeletal tumours of foot or ankle make up about 4–5% of all musculoskeletal tumours. Fortunately, about 80% of them are benign. However, due to the rarity and low prevalence of each single tumour entity, diagnosis is often difficult and delayed.
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Ultrasonography is an important diagnostic tool to safely recognize ganglion cysts as a frequently encountered ‘bump’ in the foot.
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In suspicious lesions, malignancy must be excluded histologically in a tumour center by biopsy after imaging procedures using x-ray, computed tomography (CT) and magnetic resonance imaging (MRI).
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Most of the benign tumours do not require any further surgical therapy. Resection should be performed in the case of locally aggressive tumour growth or local symptoms of discomfort. In contrast to malignant tumours, the primary purpose in the resection is the least possible loss of function.
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Purpose
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To report accuracy, repeatability, and agreement of Cobb angle measurements on radiographs and/or stereo-radiographs (EOS) compared against one another or against other imaging modalities.
Methods
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This review follows Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. A literature search was conducted on 21 July 2021 using Medline, Embase, and Cochrane. Two researchers independently performed title/abstract/full-text screening and data extraction. Studies were eligible if they reported Cobb angles, and/or their repeatability and agreement, measured on radiographs and/or EOS compared against one another or against other imaging modalities.
Results
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Of the 2993 records identified, 845 were duplicates and 2212 were excluded during title/abstract/full-text screening. Two more relevant studies were identified from references of eligible studies, leaving 14 studies for inclusion. Two studies compared Cobb angles from EOS vs CT, while 12 compared radiographs vs other imaging modalities: EOS, CT, MRI, digital fluoroscopy, or dual-energy x-ray absorptiometry. Angles from standing radiographs tended to be higher than those from supine MRI and CT, and angles from standing EOS tended to be higher than those from supine or prone CT. Correlations across modalities were strong (R = 0.78–0.97). Inter-observer agreement was excellent for all studies (ICC = 0.77–1.00), except one (ICC = 0.13 radiographs and ICC = 0.68 for MRI).
Conclusion
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Differences of up to 11º were found when comparing Cobb angles across combinations of imaging modalities and patient positions. It is not possible, however, to determine whether the differences observed are due to the change of modality, position, or both. Therefore, clinicians should be careful when utilizing the thresholds for standing radiographs across other modalities and positions for diagnosis and assessment of scoliosis.
