French Lumbar Total Disk Replacement Observational Study
PTDL
1 other identifier
observational
600
1 country
70
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
Longer than P75 for all trials
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 18, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 6, 2015
February 1, 2015
6.5 years
February 18, 2015
March 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the rate of re-intervention during the first 5 years after fitting of total disk replacement
5 years
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic France SASlead
- DePuy Synthescollaborator
- LDR Médicalcollaborator
Study Sites (70)
Clinique Herbert
Aix-les-Bains, France
Clinique HERBERT
Aix-les-Bains, France
C.H.U. D Angers
Angers, France
CH Louis Pasteur
Bagnols-sur-Cèze, 30200, France
Centre Medical Chateau Gaillard
Besançon, France
CH BESANCON - Hôpital Jean Minjoz
Besançon, France
Hopital Lapeyronie
Besançon, France
Polyclinique de Bois Bernard
Bois-Bernard, 62320, France
Polyclinique de Bois Bernard
Bois-Bernard, France
CHU Bordeaux
Bordeaux, France
CHU de Bordeaux - CHU Pellegrin
Bordeaux, France
Clinique Privé Jean Villar
Bruges, France
Clinique Saint Jean
Cagnes-sur-Mer, France
Clinique SAINT JEAN
Cagnes-sur-Mer, France
Hopital Prive Cannes Oxford
Cannes, France
Clinique Du Parc
Castelnau-le-Lez, 34171, France
Polyclinique Du Sidobre
Castres, France
Hopital Paul d'Egine
Champigny-sur-Marne, France
Hôpital Privé Paul d'Egine
Champigny-sur-Marne, France
Clinique des Cèdres
Cornebarrieu, France
Chu Henri Mondor
Créteil, 94010, France
Clinique Du Grand Large
Décines-Charpieu, France
CHRU Dijon le Bocage Central
Dijon, 21079, France
C.H.R.U. de Dijon
Dijon, France
Clinique de Fontiane Les Dijon
Dijon, France
Clinique Chirurgicale du Mail
La Rochelle, France
Clinique de Blanc Mesnil
Le Blanc-Mesnil, France
Hopital Bicetre (Ap-Hp)
Le Kremlin-Bicêtre, France
Hopital Roger Salengro
Lille, France
Polyclinique Du Bois
Lille, France
Polyclinique Bordeaux Rive Droite
Lormont, France
Clinique Saint Charles
Lyon, France
Hopital P. Wertheimer
Lyon, France
Clinique Du Croise Laroche
Marcq-en-Barœul, France
APM La Timone
Marseille, 13385, France
Aphm Hopital de La Conception
Marseille, France
C.H.P. Clairval
Marseille, France
Hopital Européen
Marseille, France
Hôpital Privé Marsielle Beauregard
Marseille, France
CH Meulan - Les Mureaux
Meulan-en-Yvelines, France
Centre Aquitain du Dos
Mérignac, France
Hopital Lapeyronie
Montpellier, France
C.H.U. Nantes Hotel-Dieu
Nantes, France
Clinique Jules Verne
Nantes, France
Nouvelles Cliniques Nantaises
Nantes, France
Cmc Ambroise Pare
Neuilly-sur-Seine, France
Clinique Saint-George
Nice, 06000, France
CHU de Nice - HOPITAL PASTEUR
Nice, 06002, France
CHU de Nice
Nice, France
Hôpital Privé les Franciscaines
Nîmes, 30900, France
G H U Caremeau
Nîmes, France
Hôpital les Franciscaines
Nîmes, France
Chr Orleans
Orléans, France
Groupe Hospitalier Paris St Joseph
Paris, 75014, France
Chu Pellegrin
Paris, France
Hopital Lariboisiere
Paris, France
Hopital Saint-Joseph
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Polyclinique Saint Martin
Pessac, France
Hopital Maison Blanche Chu Reims
Reims, France
Polyclinique Saint Andre
Reims, France
Hopital Charles Nicolle Chu Rouen
Rouen, France
Hôpital privé de la Loire
Saint-Etienne, 42030, France
Clinique Belledonne
Saint-Martin-d'Hères, France
Clinique Du Parc
Saint-Priest-en-Jarez, France
Nouvelle Clinique de l'Union
St.-Jean, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Polyclinique Du Parc
Toulouse, 31400, France
Clinique Medipole Garonne
Toulouse, France
Clinique de Vitrolles
Vitrolles, France
Study Officials
- STUDY CHAIR
Jean-Bernard SCHROEDER
SNITEM
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2015
First Posted
March 6, 2015
Study Start
June 1, 2014
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
March 6, 2015
Record last verified: 2015-02