Status:
RECRUITING
Post-marketing Clinical Follow-up of the Medical Device DIVA®
Lead Sponsor:
SC Medica
Conditions:
Lumbar Disc Herniation
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
822 Patients enrolled
Trial Details
Trial ID
NCT05277818
Start Date
September 7 2022
End Date
March 15 2027
Last Update
October 31 2022
Active Locations (1)
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1
Hôpitaux Civils de Colmar
Colmar, France