Lumbar Total Disk ReplacementPTDLNCT02381574

French Lumbar Total Disk Replacement Observational Study

An observational study of Lumbar Total Disk Replacement, run by Medtronic France SAS at 70 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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 Read more about this study

Who is it for?: Any age
Conditions the study is for: Lumbar Total Disk Replacement
How many people: 600 participants
Where: 70 sitesFrance
Study dates: Jun 2014to Dec 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

70 sites in 1 country.

Jean-Bernard SCHROEDER contact

01 47 17 63 88

City, postcode or hospital

Sites recruiting now only

70 sites in 1 country

France70 sites, 40 recruiting

Clinique Herbert
Aix-les-Bains
Alain LOUVEAU
Recruiting
Clinique HERBERT
Aix-les-Bains
Active, not recruiting
C.H.U. D Angers
Angers
Olivier LUCAS
Recruiting
CH Louis Pasteur
Bagnols-sur-Cèze, 30200
Active, not recruiting
Centre Medical Chateau Gaillard
Besançon
Active, not recruiting
CH BESANCON - Hôpital Jean Minjoz
Besançon
Joel GODARD
Recruiting
Hopital Lapeyronie
Besançon
Grégory GODFRIN
Recruiting
Polyclinique de Bois Bernard
Bois-Bernard, 62320
Thierry DAVID
Thierry DAVID
Recruiting
Polyclinique de Bois Bernard
Bois-Bernard
Luc BOSCA
Recruiting
CHU Bordeaux
Bordeaux
Jean Charles LE HUEC
Jean Charles LE HUEC
Recruiting
CHU de Bordeaux - CHU Pellegrin
Bordeaux
Active, not recruiting
Clinique Privé Jean Villar
Bruges
JEAN-CHRISTOPHE CURSOLLE
Recruiting
Clinique Saint Jean
Cagnes-sur-Mer
Marc PIERUNEK
Recruiting
Clinique SAINT JEAN
Cagnes-sur-Mer
Active, not recruiting
Hopital Prive Cannes Oxford
Cannes
Ludovic RILLARDON
Recruiting
Clinique Du Parc
Castelnau-le-Lez, 34171
Grégory EDGAR ROSA
Thierry MARNAY
Recruiting
Polyclinique Du Sidobre
Castres
Gilles MARIAMBOURG
Recruiting
Hopital Paul d'Egine
Champigny-sur-Marne
Active, not recruiting
Hôpital Privé Paul d'Egine
Champigny-sur-Marne
Active, not recruiting
Clinique des Cèdres
Cornebarrieu
Active, not recruiting
Chu Henri Mondor
Créteil, 94010
Jérôme ALLAIN
Jérôme ALLAIN
Recruiting
Clinique Du Grand Large
Décines-Charpieu
Active, not recruiting
CHRU Dijon le Bocage Central
Dijon, 21079
Jacques BEAURAIN
Jacques BEAURAIN
Recruiting
C.H.R.U. de Dijon
Dijon
Olivier BOUSQUET
Recruiting
Clinique de Fontiane Les Dijon
Dijon
Active, not recruiting
Clinique Chirurgicale du Mail
La Rochelle
Samuel D'HOUTAUD
Recruiting
Clinique de Blanc Mesnil
Le Blanc-Mesnil
Active, not recruiting
Hopital Bicetre (Ap-Hp)
Le Kremlin-Bicêtre
Charles COURT
Recruiting
Hopital Roger Salengro
Lille
Active, not recruiting
Polyclinique Du Bois
Lille
Active, not recruiting
Polyclinique Bordeaux Rive Droite
Lormont
Vincent GAUTHIER
Recruiting
Clinique Saint Charles
Lyon
Active, not recruiting
Hopital P. Wertheimer
Lyon
Active, not recruiting
Clinique Du Croise Laroche
Marcq-en-Barœul
Active, not recruiting
APM La Timone
Marseille, 13385
Active, not recruiting
Aphm Hopital de La Conception
Marseille
Patrick TROPIANO
Recruiting
C.H.P. Clairval
Marseille
Jean-Luc BARAT
Recruiting
Hopital Européen
Marseille
Active, not recruiting
Hôpital Privé Marsielle Beauregard
Marseille
Philippe TISSERAND
Recruiting
Centre Aquitain du Dos
Mérignac
Active, not recruiting
CH Meulan - Les Mureaux
Meulan-en-Yvelines
Active, not recruiting
Hopital Lapeyronie
Montpellier
Martin GRAU ORTIZ
Recruiting
C.H.U. Nantes Hotel-Dieu
Nantes
Joël DELECRIN
Recruiting
Clinique Jules Verne
Nantes
Nicolas LEVASSOR
Recruiting
Nouvelles Cliniques Nantaises
Nantes
Simon-Alain LE NAELOU
Recruiting
Cmc Ambroise Pare
Neuilly-sur-Seine
Marian AGACHI
Recruiting
Clinique Saint-George
Nice, 06000
Istvan HOVORKA
Istvan HOVORKA
Recruiting
CHU de Nice - HOPITAL PASTEUR
Nice, 06002
Stéphane LITRICO
Stéphane LITRICO
Recruiting
CHU de Nice
Nice
Active, not recruiting
Hôpital Privé les Franciscaines
Nîmes, 30900
Vincent LECLERC
Sébastien TRINCAT
Recruiting
G H U Caremeau
Nîmes
Pascal KOUYOUMDJIAN
Recruiting
Hôpital les Franciscaines
Nîmes
Vincent LECLERC
Recruiting
Chr Orleans
Orléans
THIERRY DUFOUR
Recruiting
Groupe Hospitalier Paris St Joseph
Paris, 75014
Active, not recruiting
Chu Pellegrin
Paris
Jean-Marc VITAL
Recruiting
Hopital Lariboisiere
Paris
Mickael ORABI
Recruiting
Hopital Saint-Joseph
Paris
Active, not recruiting
Hôpital Européen Georges Pompidou
Paris
Active, not recruiting
Polyclinique Saint Martin
Pessac
Active, not recruiting
Hopital Maison Blanche Chu Reims
Reims
Active, not recruiting
Polyclinique Saint Andre
Reims
Active, not recruiting
Hopital Charles Nicolle Chu Rouen
Rouen
Mourad OULD-SLIMANE
Recruiting
Hôpital privé de la Loire
Saint-Etienne, 42030
Hervé TOURNEUX
Hervé TOURNEUX
Recruiting
Clinique Belledonne
Saint-Martin-d'Hères
Active, not recruiting
Clinique Du Parc
Saint-Priest-en-Jarez
Jean HUPPERT
Recruiting
Nouvelle Clinique de l'Union
St.-Jean
Active, not recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Jean-Paul STEIB
Jean-Paul STEIB
Recruiting
Polyclinique Du Parc
Toulouse, 31400
Active, not recruiting
Clinique Medipole Garonne
Toulouse
DOMINIQUE VARDON
Recruiting
Clinique de Vitrolles
Vitrolles
Gérard CASTERA
Recruiting

Other trials in France

About this study

Official title: 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

Read the 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)

Conditions: Lumbar Total Disk Replacement
Keywords: Lumbar Total Disk Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the rate of re-intervention during the first 5 years after fitting of total disk replacement
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Dec 2020

First posted6 Mar 2015 (estimated)
Study startJun 2014
Primary completionDec 2020 (estimated)
Study completionDec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lumbar Total Disk ReplacementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02381574
Sponsor's protocol ID: PTDL
Acronym: PTDL
Status last verified: Feb 2015
First submitted: 18 Feb 2015
Last updated: 6 Mar 2015
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: French Lumbar Total Disk Replacement Observational Study (FLTDR Observational Study)
ClinicalTrials.gov ID: NCT02381574
Acronym / sponsor ID: PTDL / PTDL
Conditions: Lumbar Total Disk Replacement
Keywords: Lumbar Total Disk Replacement
Study type: Observational
Recruitment status: Unknown status
Enrolment: 600 participants (estimated)
Lead sponsor: Medtronic France SASIndustry (pharma, biotech, devices)
Collaborators: DePuy Synthes, LDR Médical
Study start: Jun 2014
Primary completion: Dec 2020 (estimated)
Study completion: Dec 2020 (estimated)
First posted: 6 Mar 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objective:

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 design

Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-Bernard SCHROEDER contact

01 47 17 63 88

Jean-Bernard SCHROEDER study chair

SNITEM

70 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Total Disk Replacement, run by Medtronic France SAS at 70 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jean-Bernard SCHROEDER (01 47 17 63 88), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the rate of re-intervention during the first 5 years after fitting of total disk replacement (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02381574.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.