· web viewword, powerpoint, and excel formats should be avoided. to allow the editor to easily...

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INSTRUCTIONS TO AUTHORS

Concise Format for Reporting the Longer-Term Follow-up of a study published in Orthopaedics Traumatology Surgery and Research (Fewer than 2500 words

including summary text references legend to figures and tables)

This format is to be used when the original full-length article was published in Orthopaedics Traumatology Surgery and Research. This format is dedicated to clinical studies, mainly in follow-up of arthroplasty, reconstruction or conservative procedure (i.e not designed for basic research, diagnosis, prognosis, or economic-decision analyses). The same cohort should be assessed at a minimum 5 or 10 years of follow-up interval

Must follow the GUIDELINES in (see guidelines Authors OTSR)

Must be based on one hypothesis (exposed in the abstract and in the introduction / typically the follow-up of the former hypothesis reported in the original article but a new one related to the behavior of the procedure is well accepted) 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 (typically the same as in the original paper but fewer are preferred for a brief report). 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 2500 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 a follow-up note on randomized controlled trials (Level of Evidence I-II) should follow and submit the checklist of the CONSORT (CONsolidated Standards of Reporting Trials). Checklist of the CONSORT Group (Checklist CONSORT)

Regarding follow-up notes of 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

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http://www.clinicaltrials.gov/

http://www.consort-statement.org/consort-statement/

http://www.consort-statement.org/

http://www.consort-statement.org/

http://www.strobe-statement.org/

http://www.em-consulte.com/getInfoProduit/RCOT/instructionsAuteurs/RCOT.pdf

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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 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.

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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.).

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

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http://www.sciencedirect.com/science/article/pii/S1877056812000886

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) should include words indicating this is a follow-up note of a former study published in OTSR (indicate “a concise follow-up note of a previous report” or “follow-up note of a former studies at xx years”)

Running title (containing fewer than 80 characters including spaces)

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 trail 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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Abstract Your Abstract must be structured with the following five sections and contain

fewer than 300 words.

Background including the questions (one to four questions that will drive the building

of the paper, typically the same as in the original paper but fewer are preferred for a

brief report / the main question could be the behavior of the procedure/population

after and additional follow-up). Justify why you are reporting the results at this

interval in one sentence.

Hypothesis (related to the first that is the principal question, typically the follow-up of

the former hypothesis reported in the original article but a new one related to the

behavior of the procedure is well accepted).

Patients and Methods (including minimal description of patients populations and

methods (main variables related to questions) and the follow-up. In addition indicate

the main changes in population since the former follow-up.

Results (answers to questions in few sentences giving the results of the main variables

related to questions). You must emphasize on the new results since de former follow-

up regarding the main variables or questions.

Discussion (synthesis of the new findings regarding literature)

Level of Evidence Below Abstract: the Level of Evidence is that of the former published

study (see guidelines Authors OTSR)

Key Words: Three to five key words in English should immediately follow the abstract,

chosen among the English key words of the Index Medicus Medical Subject Headings

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1. Introduction (maximum of 300 words)

One or two paragraphs are recommended. One paragraph of background (citing the

former study published in OTSR and relevant literature), one paragraph justifying the

current study (the follow-up of a former procedure/population) and exposing the

questions (one to four questions that will drive the building of the paper, typically the

same as in the original paper but fewer are preferred for a concise report / the main

question could be the behavior of the procedure/population after and additional

follow-up) and the hypothesis (related to the first that is the principal question,

typically the follow-up of the former hypothesis reported in the original article but a

new one related to the behavior of the procedure is well accepted).

The questions (one to four) that will drive the manuscript should be enumerated

at the end of the introduction. The variables introduced in Material and Methods

chapter should be related to these questions. The answers should be detailed in the

abstract and a separate paragraph should be related to each question in results and

discussion sections.

The same questions are detailed at the background section of the abstract and at the

end of the introduction section. The Results and Discussion sections should be built

on the answers enumerated in the same order with a dedicated paragraph for each

question.

2. Patients and Methods (no longer than 300 words)

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Authors must provide the filled STROBE table (see http://www.strobe-statement.org)

enclosed in the electronic submission (it is not included in the word count). The patients

and Methods section should contain the following information that could be in a single

paragraph or separated in four sections as recommended below:

A Subsection entitled (2.1) Patients including minimal description of the population

(selection of patients, demographics) and the study design (retrospective or

prospective, with or without control group). Underline the main changes since the

former follow-up regarding the cohorts (death, lost for follow-up): 1) list the original

number of patients/procedures studied and the number of patients/procedures studied

since the last report. 2) the number of patients/procedures who died, the number of

patients/procedures who were lost to follow-up, and the number of

patients/procedures currently being studied. 3) the number of patients/procedures in

the updated series who were examined, the number who responded to questionnaires,

and the number with available radiographic/biological investigations. 4) basic

demographic characteristics of the cohort, especially any that might affect results

(age, diagnosis, gender, height, weight, and level of activity).

A subsection named (2.2) Methods including brief enumeration of the surgery using

citation of the former publication of the cohort in OTSR.

A subsection entitled (2.3) Methods of assessment should be the same as in the

former publication in OTSR. In this section authors should list (but not describe) the

methods used to assess the study group. If any additional method it should be briefly

described using relevant citation for details. Only variables directly related to the

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questions should be detailed. The variables should be listed in accordance with the

order of appearance of questions (principal then accessories).

Finally a subsection entitled (2.4) statistical analysis The description of statistics

should list the variables related to the questions (separating descriptive and analysis

study). The description of statistical analyses should be sufficient including the name

of the test performed, the number (%) of missing values (only for main variables) as

well as management of these missing values. The tests used to compare the study

groups between follow-up intervals should be detailed. Use of survival analysis are

strongly recommended including confidence intervals and indicating the number of

patients in study at last follow-up. The end points should be explicated and adapted

to the study design (see below in result section)

3. Results (maximum of 300 words)

This section should be dedicated to what is really new by performing the assessment

at the new follow-up interval.

Briefly expose the results regarding each in the same order that previously given (i.e.

begin with the main question and related variables).

Tables are the best way to expose results in detail in a concise manner staying below

300 required words for the Results section. Tables are required to enhance

comparison of cohorts between two follow-up intervals.

The following data should be exposed in absolute value and/or in survival analysis: 1)

the number of patients in whom the primary procedures is still intact, 2) the number

of procedures revised for any reason, 3) the number of procedures revised for any

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reason excluded infection, 4) the number of procedures related to mechanical

complications (breakage of device, wear, …), 5) the number of procedures that failed

(or impending failure) related to the natural history of disease (tumor or infection

recurrence, degenerative changes, loosening of components, instability, ...).

An additional paragraph may contain additional unexpected results and complications

4. Discussion (maximum of 500 words)

Begin with the answer to the question #1 and briefly justify the assessment of the

procedure/population after a new follow-up.

Then briefly expose in the following paragraphs the answer to the following

questions(#2 to #4). In this paragraph you must emphasize what does the new follow-

up bring by comparing with your previous report and with the literature. Tables

should be adequate to write a concise and precise discussion when a large number of

data are coming from the literature. By doing so your discussion could be limited to

the most relevant features.

The last paragraph could be the conclusion underlining in few sentences the major

outcome of your study (i.e. what is really new, the message to take home). You may

emphasize the followings: major factors limiting the longevity of the procedure,

recommendations regarding the continued use of the procedure, if the procedure is no

longer performed, lessons applicable to the procedure that is currently done.

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Acknowledgments

Note any acknowledgments. Begin with, “We thank…” and note the nature of the

contribution.

Conflict of interest

Conflict of interest disclosure statement. See above and at (see guidelines Authors

OTSR)

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References

All references cited in the text must be included in the reference list. All the

references in the reference list must be cited in the text by a number between square

brackets. If the reference includes more than 6 authors, the six first are cited followed

by “et al.”

All the references used should be accessible to the reader, which excludes personal

communications, unpublished data, doctoral dissertations, and conference papers that

have not been published.

The reference list should be presented separately at the end of the article.

The reference list should be supplied at the end of the manuscript; the references

should be listed and numbered in the order they appear in the text using Arabic

numerals.

References to Revue de Chirurgie Orthopédique should cite: - before 1 January 2009:

the French-language journal (Rev Chir Orthop) with the title in English. - after 1

January 2009: only the English-language journal (Orthop Traumatol Surg Res)

Journal titles are abbreviated following the U.S. National Library of Medicine

nomenclature. Examples of references:

Journal article:1. Lecerf G, Fessy MH, Philippot R, Massin P, Giraud F, Flecher X, et al. Femoral

offset: anatomical concept, definition, assessment, implications for preoperative

templating and hip arthroplasty. Orthop Traumatol Surg Res 2009;95:210-9.

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2. Viste A, Chouteau J, Testa R, Chèze L, Fessy MH, Moyen B. Is transverse

acetabular ligament an anatomical landmark to reliably orient the cup in primary

total hip arthroplasty? Orthop Traumatol Surg Res 2011;97:241-5.

Journal supplement:

1. Gleyze P, Clavert P, Flurin PH, Laprelle E, Katz D, Toussaint B, et al.

Management of the stiff shoulder. A prospective multicenter comparative study of the

six main techniques in use: 235 cases. Orthop Traumatol Surg Res 2011;97(8

Suppl):S167-81.

Book:

1. Neyret P, Demey G. Traité de chirurgie du genou. 1st ed. Paris: Elsevier Masson;

2012.

Book chapter:

1. Glick JM. Complications of hip arthroscopy by the lateral approach. In: Shermann

OH, Minkoff J, editors. Current management of orthopaedics: arthroscopic surgery.

Baltimore: W. Wilkins; 1990. p. 1-9.

Publication of conference papers:

1. Trojani C. Traumatic acromio- and sternoclavicularcjoint dislocation. In: Huten D,

editor. Cahiers d’enseignement de la SoFCOT: conférences d’enseignement. Paris:

Elsevier Masson; 2011 [p.21-48].

Articles in press are cited as above, followed by: in press, year of publication.

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In-text citations should appear before commas and periods and located in a sentence

immediately after the point they are documenting.

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Tables

Tables with table legends and table footnotes at the bottom of the table. Each table should appear on

a separate sheet. Tables should be numbered in order of citation in the text. They should be

numbered in Arabic numerals in the order they are first cited in the text. (1, 2, 3,..).. Any results that

can be expressed typographically can be presented in tables, provided that they are clearly

presented. For small clinical series, a summary table can display all the data for each of the

observations. Each table must be cited in the text. Each table should be headed by an informative

title and any explanations or notes concerning the units of measure, abbreviations, or statistics

should be footnoted below the table. The tables should not be included in the body of the

manuscript.

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Legends to figures

In these follow-up notes it is recommended to use figures used in the former report with a

longer follow-up that are particularly of interest to support the evolution of the procedure at

different follow-up intervals.

Figure legends should be on separate pages from the manuscript.

The figures are cited in the text by number (Arabic numerals) in the order they appear in the

text. They must be separate from the text, i.e., not integrated into the text file. The figures

(diagrams, drawings, color or black-and-white photos, videos [for the electronic version],

histograms, graphs) should always be provided in separate files, one file for each figure, or in a

zipped file with one file per figure. The figures can be supplied in color: they will be published

in color in the electronic versions (OTSR and RCOT) and in black and white in the paper

version (RCOT).

All problems should be addressed to: [email protected]

The figure legends are placed after the text (see above). The figures reinforce the text to

illustrate or present the results that cannot be presented as a table. Figures comprise

photographs, radiographs but also histograms and graphs. Figures should be provided in TIFF

(.tif), EPS (.eps), or PDF (.pdf) format. Accepted formats for videos are MPG-1 and MPG-2

(.mpg), MPEG-4 (.mp4), AVI (.avi), GIF (.gif), and Quicktime movie (.mov). Word,

Powerpoint, and Excel formats should be avoided. To allow the editor to easily identify the

figures, please name the files with the figure number and the format used, e.g., “fig1.tif.”

The minimum resolution for the figures should be 300 dpi for black-and-white or color

photographs and 500-1000 dpi for graphs or diagrams. High resolution is absolutely necessary

for printing.

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For any use of a figure and text already published, the author must provide the written

permissions letter. The author must make the request from the publisher and/or author of the

original publication.

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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