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<docDscr>
  <citation>
    <titlStmt>
      <titl></titl>
      <IDNo>
        <_value></_value>
      </IDNo>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study            </titl>
      <altTitl>
                    FAST                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73368-en            </IDNo>
      <IDNo agency="PEF">
                    73368                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73368                </IDNo>
      <IDNo agency="NCT">
                    NCT02511158                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Shahnaz KLOUCHE                                                                                                                <ExtLink title="IdRef" URI="250409623" role="pi id"/>
                                                        </AuthEnty>
      <AuthEnty affiliation="FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT">
        <ExtLink title="SIREN" URI="790937023" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Nicolas LEFEVRE                                                                                                                <ExtLink title="IdRef" URI="285321870" role="pi id"/>
                                                        </AuthEnty>
      <AuthEnty affiliation="FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT">
        <ExtLink title="SIREN" URI="790937023" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Eugenie VALENTIN                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL D&amp;#039;ETUDES DEMOGRAPHIQUES (INED)">
        <ExtLink title="ROR" URI="https://ror.org/02cnsac56" role="organisation id"/>
        <ExtLink title="SIREN" URI="180037020" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
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    <prodStmt>
      <producer role="sponsor">
                                            FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT                                            <ExtLink title="SIREN" URI="790937023" role="sponsor id"/>
                    
                </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT                                            <ExtLink title="SIREN" URI="790937023"/>
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT" email="dr.bohu@chirurgiedusport.com">
                    Yoann;BOHU
                                            <ExtLink title="SIREN" URI="790937023" role="organisation id"/>
                                    </contact>
      <contact affiliation="FOND DE DOTATION POUR LA RECHERCHE CLINIQUE EN ORTHOPEDIE ET PATHOLOGIE DU SPORT" email="docteurlefevre@gmail.com">
                    Nicolas;LEFEVRE
                                            <ExtLink title="SIREN" URI="790937023" role="organisation id"/>
                                    </contact>
      <contact affiliation="INSTITUT NATIONAL D'ETUDES DEMOGRAPHIQUES (INED)" email="eugenie@chirurgiedusport.com">
                    Eugenie;VALENTIN
                                            <ExtLink title="ROR" URI="https://ror.org/02cnsac56" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180037020" role="organisation id"/>
                                    </contact>
      <depDate date="2026-10-17"/>
      <distDate date="2026-10-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <studyAuthorization>
    <authorizingAgency>CNIL                </authorizingAgency>
    <authorizingAgency>CPP                </authorizingAgency>
    <authorizingAgency>Other                </authorizingAgency>
  </studyAuthorization>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Anterior Cruciate Ligament</keyword>
      <keyword vocab="" vocabURI="">
                    ACL Reconstruction</keyword>
      <keyword vocab="" vocabURI="">
                    Sport injuries</keyword>
      <topcClas vocab="health theme">
                        Physical and Rehabilitation Medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/38e57437-b2cc-4d26-a46e-c5b639c01e5f"/>
                                                            <ExtLink title="MeSH" URI="D010810"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Orthopaedics and traumatology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c4538836-ae58-4941-b544-50f53e979e20"/>
                                                            <ExtLink title="MeSH" URI="D009985 | D014194"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Dislocation or strain or sprain of joints or ligaments of knee                                            </topcClas>
    </subject>
    <abstract contentType="purpose">In this study we will examine patients who have undergone anterior cruciate and/or posterior cruciate ligament and/or multi ligaments reconstruction to determine the rate of re-injury, contralateral tear and functional outcomes at least two years after surgery.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2012-01-01"/>
      <collDate event="end" date="2032-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="D002648"/>
                                                    </universe>
      <universe level="age" clusion="I">Adolescent (13 to 18 years)                                                            <concept vocab="MeSH" vocabURI="D000293"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="D000368"/>
                                                    </universe>
      <universe clusion="I">Participants enrolled in the FAST cohort by one of four surgeons and meeting eligibility criteria: • One ligament or multi-ligaments tear of the knee • Surgery reconstruction with any technique                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Paraclinical data (non-biological)</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>Automatic and scheduled checking (monthly)</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[10000-20000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>500 persons per year</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Metadata-only access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>Access to data is restricted to medical director of clinical research program, surgeons and clinical research assitants of the "Fond de Dotation pour la Recherche Clinique en orthopédie et pathologie du sport"</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access not yet planned</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
