French Lumbar Total Disk Replacement Observational Study (PTDL)

March 2, 2015 updated by: Medtronic France SAS

French Lumbar Total Disk Replacement Observational Study (FLTDR Observational Study)

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

Study Overview

Status

Unknown

Conditions

Detailed 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)

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix Les Bains, France
        • Recruiting
        • Clinique HERBERT
        • Contact:
          • Alain LOUVEAU
      • Aix Les Bains, France
        • Active, not recruiting
        • Clinique HERBERT
      • Angers, France
        • Recruiting
        • C.H.U. D Angers
        • Contact:
          • Olivier LUCAS
      • Bagnols Sur Cèze, France, 30200
        • Active, not recruiting
        • CH Louis Pasteur
      • Besancon, France
        • Active, not recruiting
        • Centre Medical Chateau Gaillard
      • Besancon, France
        • Recruiting
        • CH BESANCON - Hôpital Jean Minjoz
        • Contact:
          • Joel GODARD
      • Besancon, France
        • Recruiting
        • Hopital Lapeyronie
        • Contact:
          • Grégory GODFRIN
      • Bois Bernard, France, 62320
        • Recruiting
        • Polyclinique de Bois Bernard
        • Contact:
          • Thierry DAVID
        • Principal Investigator:
          • Thierry DAVID
      • Bois Bernard, France
        • Recruiting
        • Polyclinique de Bois Bernard
        • Contact:
          • Luc BOSCA
      • Bordeaux, France
        • Recruiting
        • CHU Bordeaux
        • Contact:
          • Jean Charles LE HUEC
        • Principal Investigator:
          • Jean Charles LE HUEC
        • Principal Investigator:
          • Olivier GILLE
        • Principal Investigator:
          • Rémi MARIEY
      • Bordeaux, France
        • Active, not recruiting
        • CHU de Bordeaux - CHU Pellegrin
      • Bruges, France
        • Recruiting
        • Clinique Privé Jean Villar
        • Contact:
          • JEAN-CHRISTOPHE CURSOLLE
      • Cagnes Sur Mer, France
        • Recruiting
        • Clinique Saint Jean
        • Contact:
          • Marc PIERUNEK
      • Cagnes Sur Mer, France
        • Active, not recruiting
        • Clinique Saint Jean
      • Cannes, France
        • Recruiting
        • Hopital Prive Cannes Oxford
        • Contact:
          • Ludovic RILLARDON
      • Castelnau Le Lez Cedex, France, 34171
        • Recruiting
        • Clinique du Parc
        • Contact:
          • Grégory EDGAR ROSA
        • Contact:
          • Thierry MARNAY
        • Principal Investigator:
          • Grégory EDGAR ROSA
        • Principal Investigator:
          • Thierry MARNAY
        • Principal Investigator:
          • Guilhaume GENESTE
      • Castres, France
        • Recruiting
        • Polyclinique Du Sidobre
        • Contact:
          • Gilles MARIAMBOURG
      • Champigny Sur Marne, France
        • Active, not recruiting
        • Hôpital Paul d'Egine
      • Champigny Sur Marne, France
        • Active, not recruiting
        • Hôpital Privé Paul d'Egine
      • Cornebarrieu, France
        • Active, not recruiting
        • Clinique des Cèdres
      • Creteil Cedex, France, 94010
        • Recruiting
        • CHU Henri Mondor
        • Contact:
          • Jérôme ALLAIN
        • Principal Investigator:
          • Jérôme ALLAIN
        • Principal Investigator:
          • Alexandre POIGNARD
        • Principal Investigator:
          • François ROUBINEAU
      • Decines, France
        • Active, not recruiting
        • Clinique Du Grand Large
      • Dijon, France
        • Recruiting
        • C.H.R.U. de Dijon
        • Principal Investigator:
          • Olivier BOUSQUET
      • Dijon, France
        • Active, not recruiting
        • Clinique de Fontiane Les Dijon
      • Dijon Cedex, France, 21079
        • Recruiting
        • CHRU Dijon le Bocage Central
        • Contact:
          • Jacques BEAURAIN
        • Principal Investigator:
          • Jacques Beaurain
      • La Rochelle, France
        • Recruiting
        • Clinique Chirurgicale du Mail
        • Contact:
          • Samuel D'HOUTAUD
      • Le Blanc Mesnil, France
        • Active, not recruiting
        • Clinique de Blanc Mesnil
      • Le Kremlin Bicetre Cedex, France
        • Recruiting
        • Hôpital Bicêtre (AP-HP)
        • Contact:
          • Charles COURT
      • Lille, France
        • Active, not recruiting
        • Hôpital Roger Salengro
      • Lille, France
        • Active, not recruiting
        • Polyclinique du Bois
      • Lormont, France
        • Recruiting
        • Polyclinique Bordeaux rive droite
        • Contact:
          • Vincent GAUTHIER
      • Lyon, France
        • Active, not recruiting
        • Clinique Saint Charles
      • Lyon, France
        • Active, not recruiting
        • Hôpital P. Wertheimer
      • Marcq En Baroeul, France
        • Active, not recruiting
        • Clinique du Croisé Laroche
      • Marseille, France
        • Recruiting
        • APHM Hôpital de la Conception
        • Contact:
          • Patrick TROPIANO
      • Marseille, France
        • Recruiting
        • C.H.P. Clairval
        • Contact:
          • Jean-Luc BARAT
      • Marseille, France
        • Active, not recruiting
        • Hopital Europeen
      • Marseille, France
        • Recruiting
        • Hôpital Privé Marsielle Beauregard
        • Contact:
          • Philippe TISSERAND
      • Marseille Cedex 05, France, 13385
        • Active, not recruiting
        • APM La Timone
      • Merignac, France
        • Active, not recruiting
        • Centre Aquitain du Dos
      • Meulan, France
        • Active, not recruiting
        • CH Meulan - Les Mureaux
      • Montpellier, France
        • Recruiting
        • Hopital Lapeyronie
        • Contact:
          • Martin GRAU ORTIZ
      • Nantes, France
        • Recruiting
        • Nouvelles Cliniques Nantaises
        • Contact:
          • Simon-Alain LE NAELOU
      • Nantes, France
        • Recruiting
        • C.H.U. Nantes Hotel-Dieu
        • Contact:
          • Joël DELECRIN
      • Nantes, France
        • Recruiting
        • Clinique Jules Verne
        • Contact:
          • Nicolas LEVASSOR
      • Neuilly Sur Seine, France
        • Recruiting
        • CMC Ambroise Paré
        • Contact:
          • Marian AGACHI
      • Nice, France, 06000
        • Recruiting
        • Clinique Saint-George
        • Contact:
          • Istvan HOVORKA
        • Principal Investigator:
          • Istvan HOVORKA
      • Nice, France, 06002
        • Recruiting
        • CHU de Nice - Hopital Pasteur
        • Contact:
          • Stéphane LITRICO
        • Principal Investigator:
          • Stéphane LITRICO
      • Nice, France
        • Active, not recruiting
        • Chu De Nice
      • Nimes, France, 30900
        • Recruiting
        • Hopital Prive Les Franciscaines
        • Contact:
          • Vincent LECLERC
        • Contact:
          • Sébastien TRINCAT
        • Principal Investigator:
          • Vincent LECLERC
        • Principal Investigator:
          • Sébastien TRINCAT
        • Principal Investigator:
          • Jean Pierre HLADKY
      • Nimes Cedex 1, France
        • Recruiting
        • Hôpital les Franciscaines
        • Contact:
          • Vincent LECLERC
      • Nimes Cedex 9, France
        • Recruiting
        • G H U Caremeau
        • Contact:
          • Pascal Kouyoumdjian
      • Orleans, France
        • Recruiting
        • CHR Orléans
        • Contact:
          • THIERRY DUFOUR
      • Paris, France
        • Active, not recruiting
        • Hôpital Europeén Georges Pompidou
      • Paris, France, 75014
        • Active, not recruiting
        • Groupe Hospitalier Paris St Joseph
      • Paris, France
        • Recruiting
        • CHU Pellegrin
        • Contact:
          • Jean-Marc VITAL
      • Paris, France
        • Active, not recruiting
        • Hôpital Saint-Joseph
      • Paris Cedex 10, France
        • Recruiting
        • Hôpital Lariboisière
        • Contact:
          • Mickael ORABI
      • Pessac, France
        • Active, not recruiting
        • Polyclinique Saint Martin
      • Reims, France
        • Active, not recruiting
        • Hopital Maison Blanche Chu Reims
      • Reims, France
        • Active, not recruiting
        • Polyclinique Saint Andre
      • Rouen, France
        • Recruiting
        • Hopital Charles Nicolle Chu Rouen
        • Contact:
          • Mourad OULD-SLIMANE
      • Saint Martin D'heres, France
        • Active, not recruiting
        • Clinique Belledonne
      • St Etienne Cedex 2, France, 42030
        • Recruiting
        • Hôpital Privé de la Loire
        • Contact:
          • Hervé TOURNEUX
        • Principal Investigator:
          • Hervé TOURNEUX
        • Principal Investigator:
          • Bertrand DUMAS
      • St Jean, France
        • Active, not recruiting
        • Nouvelle Clinique De L'Union
      • St Priest En Jarez, France
        • Recruiting
        • Clinique du Parc
        • Contact:
          • Jean HUPPERT
      • Strasbourg, France, 67091
        • Recruiting
        • Hopitaux Universitaires de Strasbourg
        • Contact:
          • Jean-Paul STEIB
        • Principal Investigator:
          • Jean-Paul STEIB
      • Toulouse, France, 31400
        • Active, not recruiting
        • Polyclinique du Parc
      • Toulouse Cedex 1, France
        • Recruiting
        • Clinique Médipôle Garonne
        • Contact:
          • DOMINIQUE VARDON
      • Vitrolles, France
        • Recruiting
        • Clinique de Vitrolles
        • Contact:
          • Gérard CASTERA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Analysis of the first 600 patients implanted with a PTDL (first 200 prostheses implanted for each laboratory involved in the observational study): Medtronic, LDR Médical et Synthes SAS) during an estimated inclusion period from 6 to 18 months and a follow-up period of 5 years.

An additional follow-up from 3 to 5 years will be envisaged in a protocol amendment if requested by Authorities.

Description

Inclusion Criteria:

  • Patient who needs, according to his surgeon, a PTDL placement and has given his consent for the PTDL placement
  • Patient who agrees to participate in the observational study after information by the surgeon
  • Patient living in France and having the ability to respond alone to the questionnaire

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the rate of re-intervention during the first 5 years after fitting of total disk replacement
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic France SAS

Collaborators

DePuy Synthes
LDR Médical

Investigators

  • Study Chair: Jean-Bernard SCHROEDER, SNITEM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PTDL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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