1 INSTRUCTIONS TO AUTHORS Original articles Original article (Fewer than 3500 words including summary text references legend to figures and tables) Original articles are related to clinical or basic research regarding treatment, diagnosis, prognosis, or economic- decision analyses. Must follow the GUIDELINES in (see guidelines Authors OTSR) Must be based on one hypothesis (exposed in the abstract and in the introduction) and follow the frame of “question-driven paper”: at the end of introduction as well as in the summary authors should expose one to four questions. The structure of results and discussion sections must include corresponding paragraphs answering to these questions and discussing the pertinence of this data (one paragraph of results and discussion chapters corresponding to one question). The questions should be precise (typically the best are those answered by yes or no) avoiding too general status (avoid questions “assess the functional results” “assess the radiological results”). Authors should prefer questions more accurate like “does the factors x modify the function after the y procedure” or “did the survival of the procedure is different according to x factors” or “does the mechanical strength of the device x is modified according to factors y in vitro”. Questions must be supported by corresponding variables in the abstract as well as in the material and methods and result chapters. Tables (sometimes figures) are the best way to support questions by introducing corresponding variables, the text summarizing the main results avoiding repeating all details (this is strongly recommended to downsize the manuscript length below 3500 words all included). Your manuscript should be introduced in the following template: (see below). 1 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37
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INSTRUCTIONS TO AUTHORS
Original articles
Original article (Fewer than 3500 words including summary text references legend to figures and tables)
Original articles are related to clinical or basic research regarding treatment, diagnosis, prognosis, or economic-decision analyses.
Must follow the GUIDELINES in (see guidelines Authors OTSR)
Must be based on one hypothesis (exposed in the abstract and in the introduction) and follow the frame of “question-driven paper”: at the end of introduction as well as in the summary authors should expose one to four questions. The structure of results and discussion sections must include corresponding paragraphs answering to these questions and discussing the pertinence of this data (one paragraph of results and discussion chapters corresponding to one question). The questions should be precise (typically the best are those answered by yes or no) avoiding too general status (avoid questions “assess the functional results” “assess the radiological results”). Authors should prefer questions more accurate like “does the factors x modify the function after the y procedure” or “did the survival of the procedure is different according to x factors” or “does the mechanical strength of the device x is modified according to factors y in vitro”. Questions must be supported by corresponding variables in the abstract as well as in the material and methods and result chapters. Tables (sometimes figures) are the best way to support questions by introducing corresponding variables, the text summarizing the main results avoiding repeating all details (this is strongly recommended to downsize the manuscript length below 3500 words all included).
Your manuscript should be introduced in the following template: (see below).
We strongly recommend to authors of observational studies reporting on patients (Level of Evidence III-IV) to follow the STROBE Guidelines (STrengthening the Reporting of OBservational studies in Epidemiology) and to give at the time of submission a fulfilled table confirming the authors abound to these recommendations. This last feature is designed to improve general quality of submission as well as to facilitate dissemination of the paper and to help authors to do so.
The STROBE Initiative (see table to be filled and submitted with manuscript)
Authors that submit randomized controlled trials (Level of Evidence I-II) as well as meta-analysis should follow and submit the checklist of the CONSORT (CONsolidated Standards of Reporting Trials) Group.
Checklist of the CONSORT Group (Checklist CONSORT)
General Guidelines for Clinical Follow-up:
A minimum of 5 years of follow-up is mandatory for papers related to total joint arthroplasty with the exception of randomized case control study (for which a minimum 2 years is advised) or if unexpected complications or failures rates (without minimal follow-up)
A minimum of 2 years of follow-up is mandatory for papers related to infection (except in case of failure or unusual results). Criteria for infection healing and diagnosis must be clearly defined.
A minimum of 1 year of follow-up is mandatory for papers reporting trauma and 2 years for papers reporting management of ligament injuries (except in case unexpected rate of failure).
A minimum times corresponding to median time for recurrence is recommended for papers reporting tumors
For papers reporting mechanical or biological models (in vitro testing, finite element analysis, mechanical testing) there is no minimal time of follow-up required but reproducibility of the model and of criteria of assessment is strongly advised.
Authorship and conflict of interest
We recommend the number of authors to be limited to 6 (except for multicenter trials and level I-II randomized and meta-analyses). It is important that all authors have a real participation in any part of the study (surgery, laboratory of mechanical experiments, data collection, manuscript edition, statistics). It is corresponding author responsibility to check if all authors have this adequate participation. Whatever the number, all authors must submit a separate filled ICMJE file (to assess conflict of interest see below) that should be enclosed in the electronic submission. Conflict of interest should be declared regarding the submitted paper as well as any conflict outside the paper that may have any relation to the work. Conflict of interest should be detailed for each author at the end of the manuscript.
The journal follows the international practices relative to potential conflicts of interest in the submitted articles. Any manuscript submission must include a conflict of interest disclosure statement. A conflict of interest exists when an author and/or co-author has financial or personal relationships with other persons or organizations that may influence professional judgment concerning an essential value (patient’s well-being, research integrity, etc.). The main conflicts of interest are financial interests, clinical trials, occasional consultancies, family relations, etc. All authors of the publication must disclose any financial or personal relationships that could be considered as having a potential conflict of interest only bearing on the subject matter of the text published.1. If there is no conflict of interest in relation with the article submitted, the following statement must be added directly in the manuscript: Conflict of interest: none2. If there is one (or several) conflict(s) of interest with one or several authors of the article, the complete list of these conflicts of interest must be mentioned at the end of the manuscript, before the bibliographical references and following the presentation below, with the initials of the authors concerned and the name of the company, as in the examples below.Examples of conflict of interest statements, TO BE ADDED AT THE END OF THE TEXT, under the acknowledgments (if present):- C. R., E. L. Financial interest in Barbot S.A.;- E. L. Owner, director, employee, participation in a company’s decision body;- Other regular activities in Chups SAS;- J.-J. E. Clinical trials: as principal investigator, coordinator or main researcher for RTM SARL;- P. L. Clinical trials: as co-investigator, associate researcher collaborator in the study for
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Light & Co;- F. W. Occasional consultancies: expert reports for EFS Associated;- M. D. Occasional consultancies: consultancies for SFC;- C. G. Conferences: invitations as a presenter for KKS & Son;- M. S. Conferences: invitations as an auditor (travel expenses paid by a company) for Régis SA;- C.-A. S. Substantial contributions to the budget of an institution under author’s responsibility, Aphelion;- M. F. Close relatives employed in the companies declared below;- A.D. Conflict of interest: none.3. If no conflict of interest disclosure statement has been included by the author (co-authors), the following statement will be published in the article: Conflict of interest: the authors have not included a conflict of interest disclosure statement.
See editorial Beaufils P. Disclosure of interest or conflict of interest? Orthop Traumatol Surg Res 2012;98(4):367-8. (See OTSR June 2012 Editorial Beaufils)
OTSR agrees to use the “Uniform Requirements for manuscripts submitted to biomedical journals” (http://www.icmje.org/). Each author should include in the electronic submission an ICMJE file filed (http://www.icmje.org/coi_disclosure.pdf.).
Ethical Review Committee Statement
When required (level I-II, new devices, new treatments) an ethical board review committee statement should be submitted enclosed in the electronic submission. Regarding level I-II studies the number of clinical trial registration (ICT number (http://www.clinicaltrials.gov/) or EUDRACT files (https://eudract.ema.europa.eu/)) should be submitted within the submission.
General additional informationAll medications and other drugs should appear under their international nonproprietary name, with the trade name followed by ® in a footnote including the manufacturing laboratory and its head-office. Surgical materials and implants should be written under their generic name with a footnote mentioning the manufacturer’s name, its head office, and the trade name of the device followed by ™. The units of measure for length, height, weight, and volume must be in the metric system or their multiples. Temperatures must be in degrees Celsius and blood pressure in millimeters of mercury. The hematological and biochemical measurements should be expressed according to the International System of Units. Any abbreviation or acronym is written out in full followed by the abbreviation in parentheses at its first mention in the text. Anatomical descriptions should use the international nomenclature (anatomica parisiensis).
PLEASE REMOVE ALL INSTRUCTIONS PRIOR TO UPLOADING FINAL DRAFT TO EDITORIAL MANAGER
Template for Original article – Orthopaedics & Traumatology: Surgery & Research 4
Title page and followings
This page must include the following:
Title (containing fewer than 280 characters including spaces)
Running title (containing fewer than 80 characters including spaces)
Author name(s) (and Christian name ) (must follow authorship guidelines at (see guidelines Authors OTSR) and the affiliation
The affiliation(s), and full postal address (including ZIP code and country). Please use the vermicular language according to the country of the authors.
Identification of the corresponding author with e-mail address.
Authors must declare is they had or if their institution had industrial or institutional or academic grants or financial support regarding the current study.
The followings pages must include
Ethical review committee statement (see guidelines Authors OTSR)
and number of registration of clinical trial when mandatory: ICT number (http://www.clinicaltrials.gov/) or EUDRACT files (https://eudract.ema.europa.eu/)
Word Count (from title to the end of manuscript including tables, legend to figures and references): Maximum is 3500 words for original articles.
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Illustrations with multiple figures (eg, 1A, 1B, 1C) must be labeled "A," "B," and "C" in the
lower left hand corner. Each illustration requires a separate legend.
Figures should be uploaded and separately labeled in EES.
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STROBE Guidelines for authors of OTSR
To be used by authors of all observational clinical studies published in OTSR. For this purpose a cohort study (the term used by STROBE) is considered a longitudinal study typically reporting outcomes of treatment in one or more cohorts; a case-control study is one identifying factors in outcomes; a cross-sectional study is one to identify the prevalence of factors or characteristics in a population at a single point in time. This checklist table is modified from The STROBE Initiative, www.strobe-statement.org and should be filled and submitted within the electronic submission
Item No
Recommendation
Please insert check where included or N/A where not applicable
Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract(b) Provide in the abstract an informative and balanced summary of what was done and what was found
IntroductionBackground/rationale 2 Explain the scientific background and rationale
for the investigation being reportedObjectives 3 State specific objectives, including any pre
specified hypotheses
MethodsStudy design 4 Present key elements of study design early in the
paperSetting 5 Describe the setting, locations, and relevant
dates, including periods of recruitment, treatment, follow-up, and data collection
Participants 6 (a) Cohort study—Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-upCase-control study—Give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controlsCross-sectional study—Give the eligibility criteria, and the sources and methods of selection of participants(b) Cohort study—For matched studies, give matching criteria and number of treated and untreatedCase-control study—For matched studies, give matching criteria and the number of controls per case
Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable
Data sources/ measurement
8* For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group
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Bias 9 Describe any efforts to address potential sources of bias
Study size 10 Explain how the study size was arrived atQuantitative variables 11 Explain how quantitative variables were handled in
the analyses. If applicable, describe which groupings were chosen and why
Statistical methods 12 (a) Describe all statistical methods, including those used to control for confounding(b) Describe any methods used to examine subgroups and interactions(c) Explain how missing data were addressed(d) If applicable, explain how loss to follow-up was addressed(e) Describe any sensitivity analyses
ResultsParticipants 13* (a) Report numbers of individuals at each stage
of study—eg, numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analyzed(b) Give reasons for nonparticipation at each stage
Descriptive data 14* (a) Give characteristics of study participants (eg, demographic, clinical, social) and information on other treatments and potential confounders(b) Indicate number of participants with missing data for each variable of interest(c) Cohort study—Summarize follow-up time (eg, average and total amount)
Outcome data 15* Report numbers of outcome events or summary measures over time
Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and why they were included(b) Report category boundaries when continuous variables were categorized(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period
Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses
DiscussionKey results 18 Summarise key results with reference to study
objectivesLimitations 19 Discuss limitations of the study, taking into account
sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias
Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence
Generalisability 21 Discuss the generalisability (external validity) of the study results
Other informationFunding 22 Give the source of funding and the role of the funders
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for the present study and, if applicable, for the original study on which the present article is based
*Give information separately for cases and controls.
Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. Information on the STROBE Initiative is available at http://www.strobe-statement.org.
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CONSORT 2010 checklist of information to include when reporting a randomised trial*
When reporting randomised trial please follow CONSORT recommendations and systematically add a Flowchart
adding to CONSORT frame
Section/TopicItem No Checklist item
Reported on page
NoTitle and abstract
1a Identification as a randomised trial in the title1b Structured summary of trial design, methods, results,
and conclusions (for specific guidance see CONSORT for abstracts)
IntroductionBackground and objectives
2a Scientific background and explanation of rationale2b Specific objectives or hypotheses
MethodsTrial design 3a Description of trial design (such as parallel, factorial)
including allocation ratio3b Important changes to methods after trial
commencement (such as eligibility criteria), with reasons
Participants 4a Eligibility criteria for participants4b Settings and locations where the data were collected
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed
6b Any changes to trial outcomes after the trial commenced, with reasons
Sample size 7a How sample size was determined7b When applicable, explanation of any interim analyses
and stopping guidelinesRandomisation: Sequence
generation8a Method used to generate the random allocation
sequence8b Type of randomisation; details of any restriction (such
as blocking and block size) Allocation
concealment mechanism
9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
Blinding 11a If done, who was blinded after assignment to
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interventions (for example, participants, care providers, those assessing outcomes) and how
11b If relevant, description of the similarity of interventionsStatistical methods 12a Statistical methods used to compare groups for
primary and secondary outcomes12b Methods for additional analyses, such as subgroup
analyses and adjusted analyses
ResultsParticipant flow (a diagram is strongly recommended)
13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome
13b For each group, losses and exclusions after randomisation, together with reasons
Recruitment 14a Dates defining the periods of recruitment and follow-up
14b Why the trial ended or was stoppedBaseline data 15 A table showing baseline demographic and clinical
characteristics for each groupNumbers analysed 16 For each group, number of participants (denominator)
included in each analysis and whether the analysis was by original assigned groups
Outcomes and estimation
17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)
17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory
Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)
DiscussionLimitations 20 Trial limitations, addressing sources of potential bias,
imprecision, and, if relevant, multiplicity of analysesGeneralisability 21 Generalisability (external validity, applicability) of the
trial findingsInterpretation 22 Interpretation consistent with results, balancing
benefits and harms, and considering other relevant evidence
Other informationRegistration 23 Registration number and name of trial registryProtocol 24 Where the full trial protocol can be accessed, if
availableFunding 25 Sources of funding and other support (such as supply
of drugs), role of funders
*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.
