Post-marketing Clinical Follow-up of the Medical Device DIVA®
ConditionLumbar Disc Herniation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSC Medica
About this trial
Observational, ambispective, longitudinal, comparative, open, multicentric study.
The main objective is to compare the performance of care in patients operated with and without DIVA®.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Surgery lumbar disc herniation
Treatment groups
822 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov