Comparing outcomes of lumbar disc herniation surgery with and without DIVA® implant
Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery
SC Medica · NCT05277818
This study is testing whether using the DIVA® implant during surgery for a herniated disc helps patients recover better and reduces the need for more surgeries compared to those who don't get the implant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 822 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SC Medica (industry) |
| Locations | 1 site (Colmar) |
| Trial ID | NCT05277818 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults who have undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation and have been operated on for at least 12 months.
Not a fit: Patients with a history of spinal pathologies, malformations, or previous surgeries on the spine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of the DIVA® implant, potentially improving surgical outcomes for patients with lumbar disc herniation.
How similar studies have performed: While this study is observational and focuses on a specific device, similar studies evaluating surgical outcomes with different implants have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Colmar
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Disc Herniation