Comparing outcomes of lumbar disc herniation surgery with and without DIVA® implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of the DIVA® implant in patients who have undergone surgery for lumbar disc herniation. It will compare the performance of care between those who received the DIVA® implant and those who did not, focusing on reoperation rates for any cause, excluding trauma. The study is multicentric and will follow patients for at least 12 months post-surgery to gather longitudinal data on their outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hôpitaux Civils de Colmar
  Colmar, France Recruiting

Study contacts

• Study coordinator: Aurélie MULLER
• Email: dpo@sc-medica.com
• Phone: +33 3 88 23 71 04

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.