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NCT Number: NCT05277818

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

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

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

Recruiting

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Civils de Colmar

Colmar, France

Location status: Recruiting

Location contact

Robin SROUR, MD

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery lumbar disc herniation

Procedure

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

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie MULLER

CONTACT

[email protected]

+33 3 88 23 71 04

Sponsors and collaborators

Lead sponsor

SC Medica

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 14, 2022
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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