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French Lumbar Total Disk Replacement Observational Study

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02381574
Acronym
PTDL
Enrollment
600
Registered
2015-03-06
Start date
2014-06-30
Completion date
2020-12-31
Last updated
2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Total Disk Replacement

Keywords

Lumbar Total Disk Replacement

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)

Interventions

None listed

Sponsors

DePuy Synthes
CollaboratorINDUSTRY
LDR Médical
CollaboratorUNKNOWN
Medtronic France SAS
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Evaluate the rate of re-intervention during the first 5 years after fitting of total disk replacement5 years

Countries

France

Contacts

Primary ContactJean-Bernard SCHROEDER
01 47 17 63 88

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026