French Lumbar Total Disk Replacement Observational Study (PTDL)

Medtronic

Status: Unknown

Conditions: Lumbar Total Disk Replacement

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02381574

PTDL

Details and patient eligibility

About

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

Full 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)

Enrollment: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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