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

SC Medica

Status: Enrolling

Conditions: Lumbar Disc Herniation

Treatments: Procedure: Surgery lumbar disc herniation

Study type: Observational

Funder types: Industry

Identifiers

NCT05277818

2021-A02667-34

Details and patient eligibility

About

Observational, ambispective, longitudinal, comparative, open, multicentric study.

The main objective is to compare the performance of care in patients operated with and without DIVA®.

Full description

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

Enrollment: 822 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

822 participants in 2 patient groups

Patient with medical device DIVA®

Description:

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

Treatment:

Procedure: Surgery lumbar disc herniation

Patient without medical device DIVA®

Description:

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

Treatment:

Procedure: Surgery lumbar disc herniation