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

Last updated: October 27, 2022
Sponsor: SC Medica
Overall Status: Active - Recruiting

Phase

N/A

Condition

Radiculopathy

Spondylolisthesis

Hernia

Treatment

N/A

Clinical Study ID

NCT05277818
2021-A02667-34
  • Ages > 18
  • All Genders

Study 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®.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patient, having undergone surgery for a degenerative or traumatic mono-segmentallumbar disc herniation, without any other associated pathology, operated with orwithout 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 personaldata.

Exclusion

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 oradministrative decision);
  • Patient not benefiting from a social security scheme.

Study Design

Total Participants: 822
Study Start date:
September 07, 2022
Estimated Completion Date:
March 15, 2027

Study Description

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

Connect with a study center

  • Hôpitaux Civils de Colmar

    Colmar,
    France

    Active - Recruiting

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