The promotion and practice of evidence-based medicine necessitates a critical evaluation of medical literature including the “gold standard” of randomised clinical trials. Recent studies have examined the quality of randomised clinical trials in various surgical specialties, but no study has focused on pediatric orthopedics. The purpose of this study was to assess and describe the quality of randomised clinical trials published in the last ten years in journals with high clinical impact in pediatric orthopaedics. All of the randomised clinical trials in pediatric orthopedics published in five well-recognised journals between 1995–2005 were reviewed using the Detsky
Low back pain (LBP) is the main cause of disability worldwide and is primarily triggered by intervertebral disc degeneration (IDD). Although several treatment options exist, no therapeutic tool has demonstrated to halt the progressive course of IDD. Therefore, several clinical trials are being conducted to investigate different strategies to regenerate the intervertebral disc, with numerous studies not reaching completion nor being published. The aim of this study was to analyze the publication status of clinical trials on novel regenerative treatments for IDD by funding source and identify critical obstacles preventing their conclusion. Prospective clinical trials investigating regenerative treatments for IDD and registered on 25 clinical trials were identified. Among these, only 6 (24%) have been published. The most common source of funding was university (52%), followed by industry (36%) and private companies (12%). Investigational treatments included autologous (56%) or allogeneic (12%) products alone or in combination with a carrier or delivery system (32%). The latter were more likely utilized in industry or privately funded studies (Fig. 1, p=0.0112). No significant difference was found in terms of funding regarding the publication status of included trials (Table 1, p=0.9104). Most clinical trials investigating regenerative approaches for the treatment of IDD were never completed nor published. This is likely due to multiple factors, including difficult enrollment, high dropout rate, and publication bias3. More accurate design and technical support from stakeholders and clinical research organization (CROs) may likely increase the quality of future clinical trials in the field. For any figures or tables, please contact the authors directly.
The purpose of this study was to develop a quality appraisal tool for the assessment of laboratory basic science biomechanical studies. Materials andScore development comprised of the following phases: item identification/development, item reduction, content/face/criterion validity, weighting, test-retest reliability and internal consistency. For item identification/development, the panel was asked to independently list criteria and factors they considered important for cadaver study and generate items that should be used to appraise cadaver study quality. For content validity, the content validity ratio (CVR) was calculated. The minimum accepted content validity index (CVI) was set to 0.85. For weighting, equal weight for each item was 6.7% [15 items]. Based on these figures the panel was asked to either upscale or downscale the weight for each item ensuring that the final sum for all items was 100%. Face validity was assessed by each panel member using a Likert scale from 1–7. Strong face validity was defined as a mean score of >5. Test-retest reliability was assessed using 10 randomly selected studies. Criterion validity was assessed using the QUACS scale as standard. Internal consistency was assessed using Cronbach's alpha. Five items reached a CVI of 1 and 10 items a CVI of 0.875. For weighting five items reached a final weight of 10% and ten items 5%. The mean score for face validity was 5.6. Test-retest reliability ranged from 0.78–1.00 with 9 items reaching a perfect score. Criterion validity was 0.76 and considered to be strong. Cronbach's alpha was calculated to be 0.71 indicating acceptable internal consistency. The new proposed quality score for basic science studies consists of 15 items and has been shown to be reliable, valid and of acceptable internal consistency. It is suggested that this score should be utilised when assessing basic science studies.
Systematic reviews (SR) can provide physicians with effective means to further strengthen their practice and identify gaps in clinical knowledge. The focus of any SR is to identify the current state of evidence for a given treatment or condition, with the hopes of providing the best interventional methods physicians can base their practice on. In paediatric orthopaedics, high-level studies are lacking, thus potentially limiting the effectiveness of SRs in the field. There isn't one specific way to qualify research on its effectiveness, but there has been gradual enhancement in finding ways to identify a successful and reproducible study. The purpose of this study was to evaluate the quality of paediatric orthopaedic SRs, and highlight aspects of these SRs that have contributed to improved outcomes. A literature review was performed in EMBASE, MEDLINE and Cochrane databases to identify pre-existing systematic reviews that have been published in five well-known orthopaedic journals between 2007 and 2017. SRs were included if the study population was between 0 and 18 years of age. Selected articles had an AMSTAR checklist applied in order to score the studies on their quality and methodology. Articles were independently reviewed by two reviewers to determine the extent of AMSTAR guidelines fulfillment. A total of 40 SRs were identified and reviewed, 20 of which partially or completely fulfilled AMSTAR guidelines. There was no disagreement between reviewers as to which of the analyzed articles have successfully reflected the checklist. Only 20/40 SRs analyzed at least partially fulfilled AMSTAR guidelines. One of the weaknesses identified in the reviewed papers so far is the lack of justification for the chosen study designs for SRs and what strategy was used to decide on the exclusion of articles. There needs to be clear-cut criteria that mark studies to be included and excluded in a comprehensive systematic review. Further improvements are required to ensure that full details on the involvement of papers and the success rates regarding each interventional method are included in order to strengthen the quality of SRs across the paediatric orthopaedic literature.
Clinical translation of MSC therapies in orthopaedics has been hampered by heterogeneity and a lack of standardised and validated testing protocols for quality assurance. Although minimal criteria have been proposed1, it is apparent that these do not predict performance
We evaluated the quality of guidelines on thromboprophylaxis
in orthopaedic surgery by examining how they adhere to validated
methodological standards in their development. A structured review
was performed for guidelines that were published between January
2005 and April 2013 in medical journals or on the Internet. A pre-defined
computerised search was used in MEDLINE, Scopus and Google to identify
the guidelines. The AGREE II assessment tool was used to evaluate
the quality of the guidelines in the study. Seven international and national guidelines were identified.
The overall methodological quality of the individual guidelines
was good. ‘Scope and Purpose’ (median score 98% interquartile range
(IQR)) 86% to 98%) and ‘Clarity of Presentation’ (median score 90%,
IQR 90% to 95%) were the two domains that received the highest scores. ‘Applicability’
(median score 68%, IQR 45% to 75%) and ‘Editorial Independence’
(median score 71%, IQR 68% to 75%) had the lowest scores. These findings reveal that although the overall methodological
quality of guidelines on thromboprophylaxis in orthopaedic surgery
is good, domains within their development, such as ‘Applicability’
and ‘Editorial Independence’, need to be improved. Application of
the AGREE II instrument by the authors of guidelines may improve
the quality of future guidelines and provide increased focus on
aspects of methodology used in their development that are not robust. Cite this article: Bone Joint J 2014;96-B:19–23.
Pedicle screw fixation is a technically demanding procedure with potential difficulties and reoperation rates are currently on the order of 11%. The most common intraoperative practice for position assessment of pedicle screws is biplanar fluoroscopic imaging that is limited to two- dimensions and is associated to low accuracies. We have previously introduced a full-dimensional position assessment framework based on registering intraoperative X-rays to preoperative volumetric images with sufficient accuracies. However, the framework requires a semi-manual process of pedicle screw segmentation and the intraoperative X-rays have to be taken from defined positions in space in order to avoid pedicle screws' head occlusion. This motivated us to develop advancements to the system to achieve higher levels of automation in the hope of higher clinical feasibility. In this study, we developed an automatic segmentation and X-ray adequacy assessment protocol. An artificial neural network was trained on a dataset that included a number of digitally reconstructed radiographs representing pedicle screw projections from different points of view. This model was able to segment the projection of any pedicle screw given an X-ray as its input with accuracy of 93% of the pixels. Once the pedicle screw was segmented, a number of descriptive geometric features were extracted from the isolated blob. These segmented images were manually labels as ‘adequate’ or ‘not adequate’ depending on the visibility of the screw axis. The extracted features along with their corresponding labels were used to train a decision tree model that could classify each X-ray based on its adequacy with accuracies on the order of 95%. In conclusion, we presented here a robust, fast and automated pedicle screw segmentation process, combined with an accurate and automatic algorithm for classifying views of pedicle screws as adequate or not. These tools represent a useful step towards full automation of our pedicle screw positioning assessment system.
In cases of poor bone quality intraoperative torque measurement might be an alternative to preoperative dual energy x-ray absorptiometry (DXA) to assess bone quality in Total Hip Arthroplasty (THA). 14 paired fresh frozen human femurs were included for trabecular peak torque measurement. We evaluated an existing intraoperative torque measurement method to assess bone quality and bone strength. We modified the approach to use this method in total hip arthroplasty (THA), which has not been published before. Since there are several approaches used in THA to exposure the hip joint, we decided to prefer the measurement in the femoral head which allows every surgeon to perform this measurement. Here a 6.5 × 23 mm blade was inserted into the proximal femur without harming the lateral cortical bone (figure 1). Further tests of the proximal femur evaluated the results of this new method: DXA, micro-computed tomography (μCT) and biomechanical load tests. Basic statistical analyses and multiple regressions were done. In the femoral head mean trabecular peak torque was 4.38 ± 1.86 Nm. These values showed a strong correlation with the values of the DXA, the μCT and the biomechanical load test. In comparison to the bone mineral density captured by DXA, the results of the intraoperative torque measurement showed a superior correlation with high sensitive bone quality evaluating methods (mechanical load tests and micro-computed tomography). Hence, the use of this intraoperative torque measurement seems to be more accurate in evaluating bone strength and bone quality than DXA during THA. The torque measurement provides sensitive information about the bone strength, which may affect the choice of implant in cases of poor bone stock and osteoporosis. In clinical use the surgeon may alter the prosthesis if the device indicates poor bone quality. Furthermore, we assume that the disadvantages associated with DXA scans like radiation exposure or errors caused by potential extraosteal sclerosis and interindividual soft-tissue artifacts could be excluded.
Machine-learning (ML) prediction models in orthopaedic trauma hold great promise in assisting clinicians in various tasks, such as personalized risk stratification. However, an overview of current applications and critical appraisal to peer-reviewed guidelines is lacking. The objectives of this study are to 1) provide an overview of current ML prediction models in orthopaedic trauma; 2) evaluate the completeness of reporting following the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement; and 3) assess the risk of bias following the Prediction model Risk Of Bias Assessment Tool (PROBAST) tool. A systematic search screening 3,252 studies identified 45 ML-based prediction models in orthopaedic trauma up to January 2023. The TRIPOD statement assessed transparent reporting and the PROBAST tool the risk of bias.Aims
Methods
Studying the indications for revision total hip arthroplasty (THA) may enable surgeons to change their practice during the initial procedure, thereby reducing the need for revision surgery. The aim of this study was to identify and describe the potentially avoidable indications for revision THA within five years of the initial procedure. A retrospective review of 117 patients (73 women, 44 men; mean age 61.5 years (27 to 88)) who met the inclusion criteria was conducted. Three adult reconstruction surgeons independently reviewed the radiographs and medical records, and they classified the revision THAs into two categories: potentially avoidable and unavoidable. Baseline demographics, perioperative details, and quality outcomes up to the last follow-up were recorded.Aims
Patients and Methods
Aims. A core outcome set for adult, open lower limb fracture has been established consisting of ‘Walking, gait and mobility’, ‘Being able to return to life roles’, ‘Pain or discomfort’, and ‘Quality of life’. This study aims to identify which outcome measurement instruments (OMIs) should be recommended to measure each core outcome. Methods. A systematic review and
The aim of this study was to systemically review the evidence for the use of intra-operative cell salvage (ICS) among patients undergoing revision hip arthroplasty, and synthesis the available data to quantify any associated reduction in allogeneic blood transfusion. An electronic database search of MEDLINE (PubMed), EMBASE, Scopus and the Cochrane Library was completed from the date of inception to 9. th. February 2021, using a search strategy and protocol created in conjunction with the PRISMA statement. Inclusion criteria were (i) adult patients >18 years, (ii) ICS utilised in one study group, (iii) revision hip arthroplasty performed. Exclusion criteria were (i) pre-donation of red blood cells, (ii) mixed reporting without dedicated subgroup analysis for revision hip arthroplasty. Screening for eligibility, and
The number of revision total hip arthroplasties (THA) is increasing. This procedure is associated with a higher complication rate than primary THA, and so it is important for patients to have realistic expectations. The aim of this systematic review was to gather and summarise the available evidence on patients’ expectations following revision THA. A literature search was conducted in PubMed, PsycINFO, Cochrane, Google Scholar and Web of Science from inception to December 2021. Methodological quality was assessed by two independent reviewers using the National Heart, Lung and Blood Institute (NIH) study
We performed this systematic overview on the overlapping meta-analyses that analyzed autologous platelet-rich plasma (PRP) as an adjuvant in the repair of rotator cuff tears and identify the studies which provide the current best evidence on this subject and generate recommendations for the same. We conducted independent and duplicate electronic database searches in PubMed, Web of Science, Scopus, Embase, Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects on September 8, 2021, to identify meta-analyses that analyzed the efficacy of PRP as an adjuvant in the repair of rotator cuff tears. Methodological
Primary malignant bone and soft tissue tumours often occur in the lower extremities of active individuals including children, teenagers and young adults. Survivors routinely face long-term physical disability. Participation in sports is particularly important for active young people but the impact of sarcoma treatment is not widely recognised and clinicians may be unable to provide objective advice about returning to sports. We aimed to identify and summarise the current evidence for involvement in sports following treatment of lower limb primary malignant bone and soft tissue tumours. A comprehensive search strategy was used to identify relevant studies combining the main concepts of interest: (1) Bone/Soft Tissue Tumour, (2) Lower Limb, (3) Surgical Interventions and (4) Sports. Studies were selected according to eligibility criteria with the consensus of three authors. Customised data extraction and
Background. The identification of novel biomarker which is highly specific and sensitive for periprosthetic joint (PJI) have the potential to improve diagnostic accuracy and ultimately improve patient outcomes. Thus, the aim of this systemic review is to identify and evaluate novel biomarkers for the preoperative diagnostics of PJI. Methods. MEDLINE, EMBASE, PubMed and Cochrane Library databases identified from 1. st. of January 2018 to 30. th. of September. 2022. We used “periprosthetic joint infection” OR “prosthetic joint infection” OR “periprosthetic infection” as the diagnosis of interest and the target index applied AND “marker”. To focus on novel biomarkers already used biomarkers of the established PJI diagnostic criteria of MSIS, ICM and EBJIS were not included in the analysis. These three criteria were considered the reference standard during
Several emerging reports suggest an important involvement of the hindfoot alignment in the outcome of knee osteotomy. At present, studies lack a comprehensive overview. Therefore, we aimed to systematically review all biomechanical and clinical studies investigating the role of the hindfoot alignment in the setting of osteotomies around the knee. A systematic literature search was conducted on multiple databases combining “knee osteotomy” and “hindfoot/ankle alignment” search terms. Articles were screened and included according to the PRISMA guidelines. A
Aims. This systematic review aimed to summarize the full range of complications reported following ankle arthroscopy and the frequency at which they occur. Methods. A computer-based search was performed in PubMed, Embase, Emcare, and ISI Web of Science. Two-stage title/abstract and full-text screening was performed independently by two reviewers. English-language original research studies reporting perioperative complications in a cohort of at least ten patients undergoing ankle arthroscopy were included. Complications were pooled across included studies in order to derive an overall complication rate.
Applications of weightbearing computed tomography (WBCT) imaging in the foot and ankle have emerged over the past decade. However, the potential diagnostic benefits are scattered across the literature, and a concise overview is currently lacking. Therefore, we aimed to systematically review all reported diagnostic applications per anatomical region in the foot and ankle. A systematic literature search was performed in the electronic databases PubMed, EMBASE, Cochrane Library, and Web of Science. Search terms consisted of “weightbearing/standing CT and ankle, hind-, mid- or forefoot”. English language studies analyzing the diagnostic applications of WBCT were included. Studies were excluded if they simulated weightbearing CT, described normal subjects, included cadaveric samples or samples were case reports. The modified Methodological Index for Non-Randomized Studies (MINORS) was applied for