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

Recruiting

• Conditions: Lumbar Disc Herniation
• Interventions: Procedure: Surgery lumbar disc herniation

• Registration Number: NCT05277818
• Lead Sponsor: SC Medica

Brief 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®.

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Study Start: 2022-09-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31
• Primary Completion: 2027-03-15
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 822

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with medical device DIVA®	Surgery lumbar disc herniation	Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with DIVA® implant
Patient without medical device DIVA®	Surgery lumbar disc herniation	Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated without DIVA® implant

Primary Outcome Measures

Name	Time	Method
Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively.	5 years	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.

Trial Locations

Locations (1)

Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France