French Lumbar Total Disk Replacement Observational Study

Last updated: March 2, 2015
Sponsor: Medtronic France SAS
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02381574
PTDL
  • All Genders

Study Summary

Primary Objective:

To evaluate the rate of re-operation during the first 5 years following the fitting of lumbar total disk replacement at the operated level and / or floors above and / or underlying, whatever the reasons

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient who needs, according to his surgeon, a PTDL placement and has given hisconsent for the PTDL placement

  • Patient who agrees to participate in the observational study after information by thesurgeon

  • Patient living in France and having the ability to respond alone to the questionnaire

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 600
Study Start date:
June 01, 2014
Estimated Completion Date:
December 31, 2020

Study Description

Secondary objectives:

The secondary objectives are:

  • Describe the reasons for re-interventions operated floor and / or (x) level (s) adjacent (s)

  • Describe the evolution of the function with the functional Oswestry score

  • Describe the evolution of lumbar radicular pain by visual analog scale (VAS)

  • Describe the evolution of the quality of life assessed by the SF12 score

  • Describe the evolution of work status

  • Describe patient satisfaction

  • Describe the complications (intraoperative, early postoperative (within 3 months of surgery), late, death)

Connect with a study center

  • Clinique HERBERT

    Aix Les Bains,
    France

    Site Not Available

  • Clinique Herbert

    Aix Les Bains,
    France

    Active - Recruiting

  • C.H.U. D Angers

    Angers,
    France

    Active - Recruiting

  • CH Louis Pasteur

    Bagnols Sur Cèze, 30200
    France

    Site Not Available

  • CH BESANCON - Hôpital Jean Minjoz

    Besancon,
    France

    Active - Recruiting

  • Centre Medical Chateau Gaillard

    Besancon,
    France

    Site Not Available

  • Hopital Lapeyronie

    Besancon,
    France

    Active - Recruiting

  • Polyclinique de Bois Bernard

    Bois Bernard, 62320
    France

    Active - Recruiting

  • CHU Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • CHU de Bordeaux - CHU Pellegrin

    Bordeaux,
    France

    Site Not Available

  • Clinique Privé Jean Villar

    Bruges,
    France

    Active - Recruiting

  • Clinique SAINT JEAN

    Cagnes Sur Mer,
    France

    Site Not Available

  • Clinique Saint Jean

    Cagnes Sur Mer,
    France

    Active - Recruiting

  • Hopital Prive Cannes Oxford

    Cannes,
    France

    Active - Recruiting

  • Clinique Du Parc

    Castelnau Le Lez Cedex, 34171
    France

    Active - Recruiting

  • Polyclinique Du Sidobre

    Castres,
    France

    Active - Recruiting

  • Hopital Paul d'Egine

    Champigny Sur Marne,
    France

    Site Not Available

  • Hôpital Privé Paul d'Egine

    Champigny Sur Marne,
    France

    Site Not Available

  • Clinique des Cèdres

    Cornebarrieu,
    France

    Site Not Available

  • Chu Henri Mondor

    Creteil Cedex, 94010
    France

    Active - Recruiting

  • Clinique Du Grand Large

    Decines,
    France

    Site Not Available

  • C.H.R.U. de Dijon

    Dijon,
    France

    Active - Recruiting

  • Clinique de Fontiane Les Dijon

    Dijon,
    France

    Site Not Available

  • CHRU Dijon le Bocage Central

    Dijon Cedex, 21079
    France

    Active - Recruiting

  • Clinique Chirurgicale du Mail

    La Rochelle,
    France

    Active - Recruiting

  • Clinique de Blanc Mesnil

    Le Blanc Mesnil,
    France

    Site Not Available

  • Hopital Bicetre (Ap-Hp)

    Le Kremlin Bicetre Cedex,
    France

    Active - Recruiting

  • Hopital Roger Salengro

    Lille,
    France

    Site Not Available

  • Polyclinique Du Bois

    Lille,
    France

    Site Not Available

  • Polyclinique Bordeaux Rive Droite

    Lormont,
    France

    Active - Recruiting

  • Clinique Saint Charles

    Lyon,
    France

    Site Not Available

  • Hopital P. Wertheimer

    Lyon,
    France

    Site Not Available

  • Clinique Du Croise Laroche

    Marcq En Baroeul,
    France

    Site Not Available

  • Aphm Hopital de La Conception

    Marseille,
    France

    Active - Recruiting

  • C.H.P. Clairval

    Marseille,
    France

    Active - Recruiting

  • Hopital Européen

    Marseille,
    France

    Site Not Available

  • Hôpital Privé Marsielle Beauregard

    Marseille,
    France

    Active - Recruiting

  • APM La Timone

    Marseille Cedex 05, 13385
    France

    Site Not Available

  • Centre Aquitain du Dos

    Merignac,
    France

    Site Not Available

  • CH Meulan - Les Mureaux

    Meulan,
    France

    Site Not Available

  • Hopital Lapeyronie

    Montpellier,
    France

    Active - Recruiting

  • C.H.U. Nantes Hotel-Dieu

    Nantes,
    France

    Active - Recruiting

  • Clinique Jules Verne

    Nantes,
    France

    Active - Recruiting

  • Nouvelles Cliniques Nantaises

    Nantes,
    France

    Active - Recruiting

  • Cmc Ambroise Pare

    Neuilly Sur Seine,
    France

    Active - Recruiting

  • CHU de Nice

    Nice,
    France

    Site Not Available

  • CHU de Nice - HOPITAL PASTEUR

    Nice, 06002
    France

    Active - Recruiting

  • Clinique Saint-George

    Nice, 06000
    France

    Active - Recruiting

  • Hôpital Privé les Franciscaines

    Nimes, 30900
    France

    Active - Recruiting

  • Hôpital les Franciscaines

    Nimes Cedex 1,
    France

    Active - Recruiting

  • G H U Caremeau

    Nimes Cedex 9,
    France

    Active - Recruiting

  • Chr Orleans

    Orleans,
    France

    Active - Recruiting

  • Chu Pellegrin

    Paris,
    France

    Active - Recruiting

  • Groupe Hospitalier Paris St Joseph

    Paris, 75014
    France

    Site Not Available

  • Hopital Saint-Joseph

    Paris,
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris,
    France

    Site Not Available

  • Hopital Lariboisiere

    Paris Cedex 10,
    France

    Active - Recruiting

  • Polyclinique Saint Martin

    Pessac,
    France

    Site Not Available

  • Hopital Maison Blanche Chu Reims

    Reims,
    France

    Site Not Available

  • Polyclinique Saint Andre

    Reims,
    France

    Site Not Available

  • Hopital Charles Nicolle Chu Rouen

    Rouen,
    France

    Active - Recruiting

  • Clinique Belledonne

    Saint Martin D'heres,
    France

    Site Not Available

  • Hôpital privé de la Loire

    St Etienne Cedex 2, 42030
    France

    Active - Recruiting

  • Nouvelle Clinique de l'Union

    St Jean,
    France

    Site Not Available

  • Clinique Du Parc

    St Priest En Jarez,
    France

    Active - Recruiting

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091
    France

    Active - Recruiting

  • Polyclinique Du Parc

    Toulouse, 31400
    France

    Site Not Available

  • Clinique Medipole Garonne

    Toulouse Cedex 1,
    France

    Active - Recruiting

  • Clinique de Vitrolles

    Vitrolles,
    France

    Active - Recruiting

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