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Post-marketing Clinical Follow-up of the Medical Device DIVA®

Post-marketing Clinical Follow-up of the Medical Device DIVA®

Recruiting
18 years and older
All
Phase N/A

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Overview

Observational, ambispective, longitudinal, comparative, open, multicentric study.

The main objective is to compare the performance of care in patients operated with and without DIVA®.

Description

The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.

Eligibility

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.

Study details
    Lumbar Disc Herniation

NCT05277818

SC Medica

26 January 2024

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