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Recruiting NCT05277818

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

— Observational Lumbar Disc Herniation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgery lumbar disc herniation.
Who it may be relevant to
Registry conditions: Lumbar Disc Herniation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery

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®.

Detailed description

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

Interventions

  • Procedure Surgery lumbar disc herniation
    Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation

Primary outcome measures

  • Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively. [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpitaux Civils de Colmar — Colmar

Identifiers

NCT: NCT05277818 · 2021-A02667-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗