Lumbar Disc Herniation
Conditions
Brief summary
Observational, ambispective, longitudinal, comparative, open, multicentric study. The main objective is to compare the performance of care in patients operated with and without DIVA®.
Detailed description
The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.
Interventions
PROCEDURESurgery lumbar disc herniation
Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation
Sponsors
SC Medica
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant; * Patient operated for at least 12 months; * Patient able to understand the information related to the study; * Patient having indicated his/her non-opposition to the collection of his/her personal data.
Exclusion criteria
* History of pathologies, malformations or surgical interventions on the spine; * Patient belonging to the first 30 operated by the surgeon with the DIVA® implant; * Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision); * Patient not benefiting from a social security scheme.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively. | 5 years | The main analysis will compare the rates of patients requiring reoperation due to any cause (excluding trauma) on the lumbar spine 5 years after surgery between the group with DIVA® and the group without DIVA®, using a Chi-square test. |
Countries
France
Contacts
Primary ContactAurélie MULLER
Outcome results
None listed