Clinical trial NCT02381574: French Lumbar Total Disk Replacement Observational Study
Official title: French Lumbar Total Disk Replacement Observational Study (FLTDR Observational Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Total Disk Replacement
Keywords: Lumbar Total Disk Replacement
Lead sponsor: Medtronic France SAS
Sponsor class: INDUSTRY
Collaborators: name: DePuy Synthes
name: LDR Médical
First posted: 2015-03-06
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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

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)

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the rate of re-intervention during the first 5 years after fitting of total disk replacement
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aix Les Bains
country: France
facility: Clinique Herbert
city: Aix Les Bains
country: France
facility: Clinique HERBERT
city: Angers
country: France
facility: C.H.U. D Angers
city: Bagnols Sur Cèze
country: France
facility: CH Louis Pasteur
city: Besancon
country: France
facility: Centre Medical Chateau Gaillard
city: Besancon
country: France
facility: CH BESANCON - Hôpital Jean Minjoz
city: Besancon
country: France
facility: Hopital Lapeyronie
city: Bois Bernard
country: France
facility: Polyclinique de Bois Bernard
city: Bois Bernard
country: France
facility: Polyclinique de Bois Bernard
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Bordeaux
country: France
facility: CHU de Bordeaux - CHU Pellegrin
city: Bruges
country: France
facility: Clinique Privé Jean Villar
city: Cagnes Sur Mer
country: France
facility: Clinique Saint Jean
city: Cagnes Sur Mer
country: France
facility: Clinique SAINT JEAN
city: Cannes
country: France
facility: Hopital Prive Cannes Oxford
city: Castelnau Le Lez Cedex
country: France
facility: Clinique Du Parc
city: Castres
country: France
facility: Polyclinique Du Sidobre
city: Champigny Sur Marne
country: France
facility: Hopital Paul d'Egine
city: Champigny Sur Marne
country: France
facility: Hôpital Privé Paul d'Egine
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Creteil Cedex
country: France
facility: Chu Henri Mondor
city: Decines
country: France
facility: Clinique Du Grand Large
city: Dijon Cedex
country: France
facility: CHRU Dijon le Bocage Central
city: Dijon
country: France
facility: C.H.R.U. de Dijon
city: Dijon
country: France
facility: Clinique de Fontiane Les Dijon
city: La Rochelle
country: France
facility: Clinique Chirurgicale du Mail
city: Le Blanc Mesnil
country: France
facility: Clinique de Blanc Mesnil
city: Le Kremlin Bicetre Cedex
country: France
facility: Hopital Bicetre (Ap-Hp)
city: Lille
country: France
facility: Hopital Roger Salengro
city: Lille
country: France
facility: Polyclinique Du Bois
city: Lormont
country: France
facility: Polyclinique Bordeaux Rive Droite
city: Lyon
country: France
facility: Clinique Saint Charles
city: Lyon
country: France
facility: Hopital P. Wertheimer
city: Marcq En Baroeul
country: France
facility: Clinique Du Croise Laroche
city: Marseille Cedex 05
country: France
facility: APM La Timone
city: Marseille
country: France
facility: Aphm Hopital de La Conception
city: Marseille
country: France
facility: C.H.P. Clairval
city: Marseille
country: France
facility: Hopital Européen
city: Marseille
country: France
facility: Hôpital Privé Marsielle Beauregard
city: Merignac
country: France
facility: Centre Aquitain du Dos
city: Meulan
country: France
facility: CH Meulan - Les Mureaux
city: Montpellier
country: France
facility: Hopital Lapeyronie
city: Nantes
country: France
facility: C.H.U. Nantes Hotel-Dieu
city: Nantes
country: France
facility: Clinique Jules Verne
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Neuilly Sur Seine
country: France
facility: Cmc Ambroise Pare
city: Nice
country: France
facility: Clinique Saint-George
city: Nice
country: France
facility: CHU de Nice - HOPITAL PASTEUR
city: Nice
country: France
facility: CHU de Nice
city: Nimes Cedex 1
country: France
facility: Hôpital les Franciscaines
city: Nimes Cedex 9
country: France
facility: G H U Caremeau
city: Nimes
country: France
facility: Hôpital Privé les Franciscaines
city: Orleans
country: France
facility: Chr Orleans
city: Paris Cedex 10
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Groupe Hospitalier Paris St Joseph
city: Paris
country: France
facility: Chu Pellegrin
city: Paris
country: France
facility: Hopital Saint-Joseph
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Pessac
country: France
facility: Polyclinique Saint Martin
city: Reims
country: France
facility: Hopital Maison Blanche Chu Reims
city: Reims
country: France
facility: Polyclinique Saint Andre
city: Rouen
country: France
facility: Hopital Charles Nicolle Chu Rouen
city: Saint Martin D'heres
country: France
facility: Clinique Belledonne
city: St Etienne Cedex 2
country: France
facility: Hôpital privé de la Loire
city: St Jean
country: France
facility: Nouvelle Clinique de l'Union
city: St Priest En Jarez
country: France
facility: Clinique Du Parc
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Toulouse Cedex 1
country: France
facility: Clinique Medipole Garonne
city: Toulouse
country: France
facility: Polyclinique Du Parc
city: Vitrolles
country: France
facility: Clinique de Vitrolles
Study officials:
affiliation: SNITEM
name: Jean-Bernard SCHROEDER
role: STUDY_CHAIR
References: