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
This trial does not accept healthy volunteersQualifiers
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 population
All patients with the DIVA® device operated in the study centers for at least 12 months (with the exception of the first 30 operated by practitioner, to take into account the learning curve), as well as all patients operated on over a period similar before the installation of DIVA® in the establishment, will receive the information note of the study. if the patient agrees to participate to the study, patient's data will be collected on a case report form.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Surgery lumbar disc herniation
Procedure/SurgerySurgery for a degenerative or traumatic mono-segmental lumbar disc herniation
Treatment groups
822 Participants
are divided into 2 treatment groupsGroup A: Patient with medical device DIVA®1 intervention
Group B: Patient without medical device DIVA®1 intervention
Trial outcomes
Primary outcomes
1
Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively.
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.
Time frame
5 years Source ClinicalTrials.gov