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

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05277818
• Other study ID #: 2021-A02667-34
• Status: Recruiting
• Start date: September 7, 2022
• Est. completion date: March 15, 2027

Study information

• Verified date: October 2022
• Source: SC Medica
• Contact: Aurélie MULLER
• Phone: +33 3 88 23 71 04
• Email: dpo[@]sc-medica.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 822
• Est. completion date: March 15, 2027
• Est. primary completion date: March 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

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

Locations

Country	Name	City	State
France	Hôpitaux Civils de Colmar	Colmar

Sponsors (1)

Lead Sponsor	Collaborator
SC Medica

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years