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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-001519-19
    Sponsor's Protocol Code Number:CHD050-16
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-08-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2016-001519-19
    A.3Full title of the trial
    Cathéter au canal des adducteurs sous sartorial (KTSS) versus cathéter fémoral (KTF) dans une démarche de réhabilitation rapide après prothèse totale de genou : Etude contrôlée, randomisée.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cathéter au canal des adducteurs sous sartorial (KTSS) versus cathéter fémoral (KTF) dans une démarche de réhabilitation rapide après prothèse totale de genou : Etude contrôlée, randomisée.
    A.3.2Name or abbreviated title of the trial where available
    KTSS
    A.4.1Sponsor's protocol code numberCHD050-16
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCentre Hospitalier Départemental Vendée de la Roche sur Yon
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCentre Hospitalier Départemental Vendée
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Départemental Vendée
    B.5.2Functional name of contact pointAUZANNEAU Lucie
    B.5.3 Address:
    B.5.3.1Street AddressBoulevard Stéphane Moreau
    B.5.3.2Town/ cityLa Roche sur Yon
    B.5.3.3Post code85925
    B.5.3.4CountryFrance
    B.5.4Telephone number330251446380
    B.5.5Fax number330251446298
    B.5.6E-maillucie.auzanneau@chd-vendee.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ropivacaïne 2.0 mg/mL
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRopivacaïne
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROPIVACAINE HYDROCHLORIDE
    D.3.9.1CAS number 84057-95-4
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prothèse totale de genou
    E.1.1.1Medical condition in easily understood language
    Prothèse totale de genou
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level SOC
    E.1.2Classification code 10042613
    E.1.2Term Surgical and medical procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L’objectif principal de cette étude est de montrer qu’en postopératoire d’une PTG, un cathéter périnerveux analgésique en position sous sartoriale (KTSS) préserve mieux la motricité du quadriceps qu’un cathéter périnerveux fémoral (KTF) même infusé avec de faibles doses d’anesthésiques locaux, cette motricité étant évaluée par un test clinique simple semi quantitatif de verrouillage du genou réalisable au lit du patient .
    E.2.2Secondary objectives of the trial
    Objectiver cette préservation de force motrice par des mesures quantitatives à l’aide d’un dynamomètre
    Montrer que l’analgésie postopératoire procurée par le KTSS n’est pas significativement différente de celle procurée par le KTFémoral
    Montrer que cette préservation de force motrice du quadriceps peut se traduire cliniquement par un délai plus rapide de reprise d’une marche autonome sans attelle en postopératoire (verrouillage efficace du genou)
    Savoir si l'administration sous sartoriale d'AL comporte un risque plus élevé de résorption systémique de l’agent anesthésique local compte tenu de la riche vascularisation de la zone (proximité immédiate des vaisseaux fémoraux)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient majeur (≥ 18 ans)
    - Devant bénéficier d’une prothèse tricompartimentale de genou (PTG) unilatérale,
    - PTG programmée sur l’un des 3 premiers jours de la semaine (lundi au mercredi inclus),
    - Score ASA I à III,
    - Chirurgie programmée non septique, sous anesthésie générale
    - Capable de comprendre le protocole
    - Consentement écrit éclairé
    - Assuré social
    - Possibilité d’être suivi dans le cadre du protocole
    E.4Principal exclusion criteria
    - Age ≥ 85 ans,
    - obésité (BMI ≥ 35),
    - révision de PTG,
    - patients non coopérants ou ne comprenant pas le français, difficultés de compréhension et d’évaluation du score de
    - douleur (EVA), dysfonction cognitive préopératoire rendant l’interrogatoire non fiable,
    - patient en incapacité de lire et/ou d’écrire (illettrisme,…)
    - troubles connus de l’hémostase,
    - chirurgie vasculaire concernant les vaisseaux fémoraux du côté opéré,
    - neuropathie du membre inférieur,
    - infection localisée au point de ponction des cathéters,
    - allergie connue à la ropivacaïne,
    - insuffisance rénale et/ou hépatique sévère,
    - prise de morphiniques depuis plus d’un mois en préopératoire,
    - intolérance aux morphiniques,
    - maladie inflammatoire rhumatismale,
    - patient sous traitement immunosuppresseur ou corticothérapie au long cours
    - allergie ou contre-indications aux traitements standards administrés en per et post-opératoires
    - Flessum >10° ou déformation avec valgum important
    - Refus de participer
    - Patient sous tutelle, curatelle, privé de liberté
    - Femme non ménopausée ayant un désir de grossesse
    E.5 End points
    E.5.1Primary end point(s)
    Force motrice du quadriceps évaluée à J2 par le score clinique international de Daniels et Worthingham(échelle de M0 : aucune contraction à M5 : force normale).
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 jours après l'intervention
    E.5.2Secondary end point(s)
    - Test de force isométrique du quadriceps évaluée par un dynamomètre (Nm)

    - Scores de douleur au repos et à la mobilisation (arthromoteur) (EVA/100)
    - Nombre de bolus de complément nécessaires dans le KT (F ou SS) depuis la salle de réveil (SSPI) jusqu’à la levée du bloc sciatique
    - Satisfaction des patients (évaluation de la qualité de l’analgésie par l’attribution d’une note globale/20)

    - Délai d’obtention de critères de sortie combinés suivants (en jours) : marche autonome avec béquilles, absence d’opiacé oral, degré de flexion du genou >70°
    - Délai nécessaire pour le patient d’être capable de se lever d’une chaise et déambuler 3 m sans attelle (avec béquille ou déambulateur) : TUG
    - Temps de déambulation sur 30m (s)
    - Délai (en heures) de récupération d’une force motrice subnormale (M4/M5) après interruption de l'administration d’Anesthésiques Locaux (AL)

    -Nausées vomissements postopératoires durant l’hospitalisation

    - Taux sériques de Ropivacaïne en SSPI et au matin de J3 (retrait du KT)
    - Consommation totale d’Oxynorm® de la SSPI jusqu’à J4 (en mg équivalent morphine IV)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Jusqu'à 2 mois après l'intervention
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Date de la dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-19
    P. End of Trial
    P.End of Trial StatusOngoing
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