Orthopaedic Clinical Research Research Articles

Quantitative Skeletal Imaging and Image-Based Modeling in Pediatric Orthopaedics.

Musculoskeletal imaging serves a critical role in clinical care and orthopaedic research. Image-based modeling is also gaining traction as a useful tool in understanding skeletal morphology and mechanics. However, there are fewer studies on advanced imaging and modeling in pediatric populations. The purpose of this review is to provide an overview of recent literature on skeletal imaging modalities and modeling techniques with a special emphasis on current and future uses in pediatric research and clinical care. While many principles of imaging and 3D modeling are relevant across the lifespan, there are special considerations for pediatric musculoskeletal imaging and fewer studies of 3D skeletal modeling in pediatric populations. Improved understanding of bone morphology and growth during childhood in healthy and pathologic patients may provide new insight into the pathophysiology of pediatric-onset skeletal diseases and the biomechanics of bone development. Clinical translation of 3D modeling tools developed in orthopaedic research is limited by the requirement for manual image segmentation and the resources needed for segmentation, modeling, and analysis. This paper highlights the current and future uses of common musculoskeletal imaging modalities and 3D modeling techniques in pediatric orthopaedic clinical care and research.

Explanatory and pragmatic trials in orthopaedics – Have we done the right studies?

Recent decades have seen marked advances in the quality of clinical orthopaedic trauma research, and with this has come a rise in the number of randomised clinical trials (RCTs) being conducted in orthopaedic trauma. These trials have been largely valuable in driving evidence-based management of injuries which previously had clinical equipoise. However, though RCTs are traditionally seen as the ‘gold standard’ of high-quality research, this research method is comprised primarily of two entities, explanatory and pragmatic designs, each with its own strengths and limitations. Most orthopaedic trials lie within a continuum between these designs, with varying degrees of both pragmatic and explanatory features. In this narrative review we provide a summary of the nuances within orthopaedic trial design, the advantages and limitations of such designs, and suggest tools which may aid clinicians in the appropriate selection and evaluation of trial designs.

Simple design and analysis strategies for solving problems in observational orthopaedic clinical research.

Randomized controlled trials are the gold standard to establishing causal relationships in clinical research. However, these studies are expensive and time consuming to conduct. This article aims to provide orthopaedic surgeons and clinical researchers with methodology to optimize inference and minimize bias in observational studies that are often much more feasible to undertake. To mitigate the risk of bias arising from their nonexperimental design, researchers must first understand the ways in which measured covariates can influence treatment, outcomes, and missingness of follow-up data. With knowledge of these relationships, researchers can then build causal diagrams to best understand how to control sources of bias. Some common techniques for controlling for bias include matching, regression, stratification, and propensity score analysis. Selection bias may result from loss to follow-up and missing data. Strategies such as multiple imputation and time-to-event analysis can be useful for handling missingness. For longitudinal data, repeated measures allow observational studies to best summarize the impact of the intervention over time. Clinical researchers familiar with fundamental concepts of causal inference and techniques reviewed in this article will have the power to improve the quality of inferences made from clinical research in orthopaedic trauma surgery.

How to fund clinical research in orthopedics and traumatology? Grants and opportunities

Objective: The aim of the study was to identify: how to fund clinical research in orthopedics and traumatology? Methods: A survey of funding for clinical research was performed. Results: According to data from the PIVOT® platform, the funding is concentrated in the USA, UK, and Medical Societies. The main sponsor was the DOD (USA), followed by the SICOT (Belgium). According to data from the DIMENSIONS® platform, there was a reduction of projects financed. The main country was the USA, followed by Japan. Regarding the amounts, the largest funders were the USA and Belgium. FAPESP (Brazil) is in the 7th position among sponsors. According to data from the InCites® platform, the main countries were the USA, China, and Japan. Conclusion: The reduction of projects in the last two years may be related to the limitations imposed by the SARS-CoV-2 pandemic. Regarding the amounts, the largest funders were the USA and Belgium. This data confirms the importance of funding from the SICOT. The main sponsor was the DOD; this data may be related to injuries that occurred in the war. The fact that the NIDA (USA) is the third largest funder may be related to the increase in the consumption of opioids for pain management. The incidence of falls among the elderly may be associated with Japan being one of the countries most supporting this area. Brazil is in the 8th position, and CAPES, CNPq, and FAPESP are among the top 20 funders. Level of Evidence IV; Descriptive Observational Study.

Contemporary Review: An Overview of the Utility of Patient-Reported Outcome Measurement Information System (PROMIS) in Foot and Ankle Surgery.

Patient-Reported Outcome Measurement Information System (PROMIS) has favorable psychometric and administrative properties in orthopaedic clinical research. It facilitates clinically meaningful data collection while minimizing administration time and survey fatigue and improving compliance. PROMIS is a critical component of patient-centered care and shared decision making, as it provides enhanced communication and engagement between patients and providers. As a validated instrument, it may also aid in measuring value-based health care quality. The goal of the current work is to provide an overview of PROMIS metrics used in orthopaedic foot and ankle, including advantages and disadvantages compared to legacy scales and PROMIS's applicability in specific foot and ankle conditions based on psychometric properties. We provide a review of the literature regarding the utilization of PROMIS as an outcome measure for specific foot and ankle procedures and conditions.

Profile of clinical research related to orthopedic disorders in the last five years

Objective: The aim of the study was to identify the profile of clinical research related to orthopedic disorders worldwide. Methods: A survey of clinical research in orthopedics was performed in the ClinicalTrials.gov platform and Plataforma Brasil databases. Results: According to data from the ClinicalTrials.gov platform, 1.142 clinical trials related to orthopedic disorders were registered from January 2017 to July 2022. Brazil is in the 14th position in the international ranking, and the Universidade de Sao Paulo (USP) occupies the 6th position among the collaborators who performed the most research in this area. The importance of the foot and ankle area in clinical research related to orthopedic disorders is evident when it is the 7th most studied worldwide and the 2nd most studied in Brazil. Most clinical trials related to orthopedic disorders worldwide target the adult or older adult population and involve interventional studies. On the other hand, most of the clinical trials related to orthopedic disorders in Brazil target the pediatric or geriatric population and involve observational studies. Conclusion: The profile of clinical research related to orthopedic disorders worldwide showed that most clinical trials targeted the adult or older adult population and aimed to treat patients, not prevent diseases. Brazil targeted the pediatric or geriatric population focusing on characterizing populations and diseases. Clinical research related to orthopedic disorders performed worldwide and in Brazil depended on sponsorship and private institutions. Level of Evidence IV; Descriptive Observational Study.

Study Types in Orthopaedics Research: Is My Study Design Appropriate for the Research Question?

When performing orthopaedic clinical research, alternative study designs can be more appropriate depending on the research question, availability of data, and feasibility. The most common observational study designs in total joint arthroplasty research are cohort and cross-sectional studies. This article describes methodological considerations for different study designs with examples from the total joint arthroplasty literature. We highlight the advantages and feasibility of experimental and observational study designs using real-world examples. We illustrate how to avoid common mistakes, such as incorrect labeling of matched cohort studies as case-control studies. We further guide investigators through a step-by-step design of a case-control study. We conclude with considerations when choosing between alternative study designs. Please visit the followinghttps://youtu.be/Zvce61cMYi8for videos that explain the highlights of the article in practical terms.

Who Is Healthy? A Review of How Equine Control Groups Are Defined in Clinical Orthopaedic Research 1999-2021.

Proper identification of healthy subjects is essential in case-control studies. However, standardized definitions of healthy controls are lacking in equine orthopaedic research. The aim of this study was to define the non-invasive methods used for selecting healthy control horses in osteoarthritis (OA), desmitis and tendinitis research. Systematic review. Case-control studies with a healthy control group and longitudinal studies where horses had to be healthy at the start were included. Studies where joints were visualized by arthroscopy or post-mortem examination were excluded. From 2,472 OA papers and 2,746 desmitis/tendinitis papers, 127 and 84 papers met the inclusion criteria respectively. For OA, 11 methods were identified for defining healthy subjects with a median of three methods used per paper. Dynamic examination, radiographic evaluation and clinical examination were the most frequent. Eight different methods were identified in the desmitis/tendinitis papers with a median of three methods per paper; ultrasonography, clinical- and dynamic examination were the most frequent. Overall, the OA and desmitis/tendinitis studies used similar methods for defining subjects as healthy, but the way the examinations were performed and interpreted was inconsistent. In several studies, healthy controls were not examined for lameness. The most common methods have limitations for detecting horses with early OA, which may have implications for interpretation of results. Standardized use of more sensitive and objective methods could be beneficial.

CORR Insights®: How Should We Measure Social Deprivation in Orthopaedic Patients?

CORR Insights®: How Should We Measure Social Deprivation in Orthopaedic Patients?

The Minimal Clinically Important Difference: A Review of Clinical Significance

Background: The minimal clinically important difference (MCID) is a term synonymous with orthopaedic clinical research over the past decade. The term represents the smallest change in a patient-reported outcome measure that is of genuine clinical value to patients. It has been derived in a myriad of ways in existing orthopaedic literature. Purpose: To describe the various modalities for deriving the MCID. Study Design: Narrative review; Level of evidence, 4. Methods: The definitions of common MCID determinations were first identified. These were then evaluated by their clinical and statistical merits and limitations. Results: There are 3 primary ways for determining the MCID: anchor-based analysis, distribution-based analysis, and sensitivity- and specificity-based analysis. Each has unique strengths and weaknesses with respect to its ability to evaluate the patient’s clinical status change from baseline to posttreatment. Anchor-based analyses are inherently tied to clinical status yet lack standardization. Distribution-based analyses are the opposite, with strong foundations in statistics, yet they fail to adequately address the clinical status change. Sensitivity and specificity analyses offer a compromise of the other methodologies but still rely on a somewhat arbitrarily defined global transition question. Conclusion: This current concepts review demonstrates the need for (1) better standardization in the establishment of MCIDs for orthopaedic patient-reported outcome measures and (2) better study design—namely, until a universally accepted MCID derivation exists, studies attempting to derive the MCID should utilize the anchor-based within-cohort design based on Food and Drug Administration recommendations. Ideally, large studies reporting the MCID as an outcome will also derive the value for their populations. It is important to consider that there may be reasonable replacements for current derivations of the MCID. As such, future research should consider an alternative threshold score with a more universal method of derivation.

Bibliometric analysis of COVID-19 related publications in Indian orthopaedic journals

BackgroundThe COVID-19 pandemic has resulted in an infodemic about the novel coronavirus SARS-CoV-2 outbreak to build knowledge and develop mitigation strategies. In addition, scientific journals across the world have studied the impact of COVID-19 on trauma and orthopaedics. MethodsA cross-sectional, bibliometric analysis of the literature was undertaken on COVID-19 related articles from three Pubmed and Scopus indexed orthopaedic journals from India, namely, Indian Journal of Orthopaedics(IJO),Journal of Clinical Orthopaedics and Trauma(JCOT), and Journal of Orthopaedics (JOO), in May 2021. All the article types and study designs were included for this review. The authors, institutions, countries, keywords, and co-authorship mapping were studied. ResultsA total of 112 COVID-19 related documents were retrieved. Period of these publications was from 2nd April 2020 to 31st May 2021. Vaishya R. (n = 16) was the most cited author, and Indraprastha Apollo Hospitals (n = 16) was the most cited research Institution. India led the list of countries in academic publication output. On keyword mapping, telemedicine was the most prominent Medical Subject Headings (MeSH) search word. ConclusionThe Indian orthopedic journals have addressed the impact of COVID-19 on orthopaedic practice in India and aborad whilst continuing to publish knowledge about basic science and clinical orthopaedic research studies. The JCOT has outperformed and become the most leading orthopaedic journal from India during the pandemic. COVID -19 articles have been fast tracked, open accessed and attracted more citations in reduced duration of time compared to non-COVID-19 papers.

Follow-up definitions in clinical orthopaedic research : a systematic review.

AimsThe follow-up interval of a study represents an important aspect that is frequently mentioned in the title of the manuscript. Authors arbitrarily define whether the follow-up of their study is short-, mid-, or long-term. There is no clear consensus in that regard and definitions show a large range of variation. It was therefore the aim of this study to systematically identify clinical research published in high-impact orthopaedic journals in the last five years and extract follow-up information to deduce corresponding evidence-based definitions of short-, mid-, and long-term follow-up.MethodsA systematic literature search was performed to identify papers published in the six highest ranked orthopaedic journals during the years 2015 to 2019. Follow-up intervals were analyzed. Each article was assigned to a corresponding subspecialty field: sports traumatology, knee arthroplasty and reconstruction, hip-preserving surgery, hip arthroplasty, shoulder and elbow arthroplasty, hand and wrist, foot and ankle, paediatric orthopaedics, orthopaedic trauma, spine, and tumour. Mean follow-up data were tabulated for the corresponding subspecialty fields. Comparison between means was conducted using analysis of variance.ResultsOf 16,161 published articles, 590 met the inclusion criteria. Of these, 321 were of level IV evidence, 176 level III, 53 level II, and 40 level I. Considering all included articles, a long-term study published in the included high impact journals had a mean follow-up of 151.6 months, a mid-term study of 63.5 months, and a short-term study of 30.0 months.ConclusionThe results of this study provide evidence-based definitions for orthopaedic follow-up intervals that should provide a citable standard for the planning of clinical studies. A minimum mean follow-up of a short-term study should be 30 months (2.5 years), while a mid-term study should aim for a mean follow-up of 60 months (five years), and a long-term study should aim for a mean of 150 months (12.5 years).Level of Evidence: Level I.Cite this article: Bone Jt Open 2021;2(5):344–350.

Orthopaedic clinical research: building a team that lasts.

Medical progress, including in the orthopaedic surgery field, depends on the interaction and collaboration between: physicians, with their expertise on the clinical setting; scientists, with their expertise on the research setting; and professionals who are skilled in both settings (clinical scientists). This leads to the need to develop research approaches which involves people who are committed and support the process, strategic planning, and a cohesive team that can execute the tasks. All these interactions must be supported financially in order to maintain the long-term viability of such team.Time management is crucial for the clinical research team. To ensure success, the research team must be flexible in order to adapt to dynamic clinical and surgical schedules. It is especially important that surgeons have regular, dedicated quality research time to maintain a consistent interaction with the team.Building a successful and productive orthopaedic clinical research programme involves many challenges in creating proper leadership, obtaining funding, setting proper resources, establishing necessary training, and providing guidance and insight around the importance of each role that every member plays on the team.Cite this article: EFORT Open Rev 2021;6:245-251. DOI: 10.1302/2058-5241.6.200058

Clinical Study of Autologous Cartilage Transplantation Based on Nano-Hydroxyapatite in the Treatment of Talar Osteochondral Injury.

Talus osteochondral damage is one of the common symptoms of chronic ankle pain in people's lives. The cartilage regeneration and self-repair ability are extremely limited, the joint cartilage lesions are often accompanied by the lesions of the subchondral bone, and the subchondral bone lesions can affect the metabolism of the cartilage above it, which brings certain difficulties to clinical treatment. Traditional methods of treating cartilage damage include microfractures and drilling. Due to large trauma, inconsistent clinical efficacy reports, poor tissue repair results, and limited donor sources, etc., the application of traditional treatment methods in the clinic has been largely limited. Therefore, finding an ideal treatment method for bone injury has been a hot spot in clinical research in orthopedics. Studies have shown that autologous cartilage transplantation via nano-hydroxyapatite has become a new treatment model, providing new ideas for clinical treatment of talar osteochondral damage. Nano-hydroxyapatite and its composites have good histocompatibility, biological activity, and bone conductivity. They are an ideal bone defect repair material, and have been initially applied in clinical practice. The preparation of nano-hydroxyapatite, its biological characteristics and the repairing effect on the composite defect of osteochondral bone were studied experimentally, and its feasibility for repairing osteochondral damage was discussed. In this paper, the unique structure and properties of natural cartilage layers are studied. In combination with bionics theory and methods, nano-hydroxyapatite micro-particle composite samples are prepared by the gel method, and the bone-forming properties of nano-composites are measured by in vitro drug release experiments. To establish a model of infectious bone injury in New Zealand white rabbits, and nano-hydroxyapatite composites were implanted into local lesions of New Zealand white rabbit models by autologous cartilage transplantation, and evaluated by imaging, blood biochemistry, histology, infection control and bone repair. The experimental results show that using the unique physical and chemical and biological properties of nano-hydroxyapatite materials. It is innovatively introduced into the treatment of talar osteochondral defects caused by open fractures. It has been proven in vitro and in vivo experiments that nano-hydroxyapatite materials can be used. As an ideal tissue engineering scaffold for the treatment of talar osteochondral defects, this provides a new way to solve clinical orthopedic problems using new nanomaterials.

Meaningful Clinical Applications of Patient-Reported Outcome Measures in Orthopaedics.

Patient-reported outcome measures (PROMs) comprise valuable data, when combined with traditional clinical information, for patient-centered health outcome assessment. While PROMs form the foundation of orthopaedic clinical research, they are invaluable tools for clinical care. PROMs play a critical role in shared decision-making with patients, as they are quantitative measures of patient health (function, pain, and satisfaction). PROMs should be incorporated into routine postoperative care for effective clinical monitoring and understanding of the response to surgery. PROMs can be additionally utilized for meaningful clinical research, predictive analytics, and value-based care delivery pathways.

Impact of COVID-19 on orthopaedic clinical service, education and research in a university hospital.

The medical system of Hong Kong has been heavily affected by COVID-19. Adaptations are necessary to continue clinical care, education, and research, while minimising the risk of infection of our staff and students. Here, we report our early experience in response to the challenge posed by the COVID-19 pandemic.The translational potential of this articleThis perspective can help to disseminate knowledge from an orthopaedic unit in a university hospital on overcoming the challenges of the COVID-19 pandemic, including clinical practice, education of medical students, and research.

What Are the Implications of Alternative Alpha Thresholds for Hypothesis Testing in Orthopaedics?

Clinical research in orthopaedics typically reports the presence of an association after rejecting a null hypothesis of no association using an alpha threshold of 0.05 at which to evaluate a calculated p value. This arbitrary value is a factor that results in the current difficulties reproducing research findings. A proposal is gaining attention to lower the alpha threshold to 0.005. However, it is currently unknown how alpha thresholds are used in orthopaedics and the distribution of p values reported. We sought to describe the use of alpha thresholds in two orthopaedic journals by asking (1) How frequently are alpha threshold values reported? (2) How frequently are power calculations reported? (3) How frequently are p values between 0.005 and 0.05 reported for the main hypothesis? (4) Are p values less than 0.005 associated with study characteristics such as design and reporting power calculations? The 100 most recent original clinical research articles from two leading orthopaedic journals at the time of this proposal were reviewed. For studies without a specified primary hypothesis, a main hypothesis was selected that was most consistent with the title and abstract. The p value for the main hypothesis and lowest p value for each study were recorded. Study characteristics including details of alpha thresholds, beta, and p values were recorded. Associations between study characteristics and p values were described. Of the 200 articles (100 from each journal), 23 were randomized controlled trials, 141 were cohort studies or case series (defined as a study in which authors had access to original data collected for the study purpose), 31 were database studies, and five were classified as other. An alpha threshold was reported in 166 articles (83%) with all but two reporting a value 0.05. Forty-two articles (21%) reported performing a power calculation. The p value for the main hypothesis was less than 0.005 for 88 articles (44%), between 0.05 and 0.005 for 67 (34%), and greater than 0.05 for 29 (15%). The smallest p value was between 0.05 and 0.005 for 39 articles (20%), less than 0.005 for 143 (72%), and either not provided or greater than 0.05 for 18 (9%). Although 50% (65 of 130) cohort and database papers had a main hypothesis p value less than 0.005, only 26% (6 of 23) randomized controlled trials did. Only 36% (15 of 42) articles reporting a power calculation had a p value less than 0.005 compared with 51% (73 of 142) that did not report one. Although a lower alpha threshold may theoretically increase the reproducibility of research findings across orthopaedics, this would preferentially select findings from lower-quality studies or increase the burden on higher quality ones. A more-nuanced approach could be to consider alpha thresholds specific to study characteristics. For example, randomized controlled trials with a prespecified primary hypothesis may still be best evaluated at 0.05 while database studies with an abundance of statistical tests may be best evaluated at a threshold even below 0.005. Surgeons and scientists in orthopaedics should understand that the default alpha threshold of 0.05 represents an arbitrary value that could be lowered to help reduce type-I errors; however, it must also be appreciated that such a change could increase type-II errors, increase resource utilization, and preferentially select findings from lower-quality studies.

Impact of academic collaboration and quality of clinical orthopaedic research conducted in low- and middle-income countries.

Background: Little is known about the quality of orthopaedic investigations conducted in low- and middle-income countries (LMICs). Academic collaboration is one model to build research capacity and improve research quality. Our study aimed to determine (1) the quality of clinical orthopaedic research conducted in LMICs, (2) the World Bank Regions and LMICs that publish the highest quality studies, (3) the pattern of collaboration among investigators and (4) whether academic collaboration between LMIC and non-LMIC investigators is associated with studies that have higher levels of evidence. Methods: Orthopaedic studies from 2004 to 2014 conducted in LMICs were extracted from multiple electronic databases. The World Bank Region, level of evidence and author country-affiliation were recorded. Collaboration was defined as a study that included an LMIC with non-LMIC investigator. Results: There were 958 studies that met inclusion criteria of 22,714 searched. Ninety-seven (10.1%) of included studies achieved Level 1 or 2 evidence, but case series (52.3%) were the most common. Collaboration occurred in 14.4% of studies and the vast majority of these (88.4%) were among academic institutions. Collaborative studies were more likely to be Level 1 or 2 (20.3% vs. 8.4%, p < 0.01), prospective (34.8% vs. 22.9% p = 0.04) and controlled (29.7% vs. 14.4%, p < 0.01) compared to non-collaborative studies. Conclusions: Although orthopaedic studies in LMICs rarely reach Level 1 or 2 evidence, studies published through academic collaboration between LMIC and non-LMIC investigators are associated with higher levels of evidence and more prospective, controlled designs.

Chinese Orthopaedic Research Society and its future focus on translational research

SummaryThe gap between orthopaedic basic research and clinical research has been reduced with the development of modern research technology and the well-accepted concept of translational medicine. The personnel involved in orthopaedic research realise more clearly than ever that basic research should be patient centred and clinical-application oriented. The mainstream of orthopaedic research has been gradually changing from bench-to-bedside to bedside-to-bench-to-bedside. This paper reviews the history of the Chinese Orthopaedic Research Society and its future development with a focus on translational medicine in musculoskeletal research and education.

CORR Insights(®): Are Patient-reported Outcome Measures in Orthopaedics Easily Read by Patients?

P atient-reported outcomes measures (PROMs) are essential tools for orthopaedic clinical research and, increasingly, for assessing the results of routine clinical practice. A good PROM accurately assesses health-related quality of life and function, identifies deficits related to physical impairments, and demonstrates change with successful interventions. Most PROMs provide written statements with which a patient is asked to agree or disagree; sometimes an activity is described and the patient is asked to indicate how difficult it is for him to do the activity. All PROMs require from the patient the ability to read and comprehend the questions being asked in the questionnaire—which are presented in written form. The fact that not all patients being queried may be able to do so is the issue that leads us to the current paper. ‘‘Health literacy’’ is a broad term, describing a person’s ability to understand and use health information. The ability to read is an essential part of this. Prior work [1] has shown that educational materials provided to patients often are written at a reading level far above that of the average patient. Are the questionnaires and surveys that we give patients any easier to read? In this paper, the authors analyzed 59 of the most commonly used orthopaedic PROMs and calculated a ‘‘readability score’’ for each, using widely available software. The vast majority of the PROMs were written at such a high level that they were ‘‘likely to be unreadable and potentially incomprehensible to most patients asked to complete them.’’