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

Sponsor
SC Medica (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05277818
Collaborator
(none)
822
Enrollment
60
Anticipated Duration (Months)

Study Details

Study Description

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®.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgery lumbar disc herniation

Detailed Description

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

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
822 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery
Anticipated Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Mar 15, 2027
Anticipated Study Completion Date :
Mar 15, 2027

Arms and Interventions

Arm Intervention/Treatment
Patient with medical device DIVA®

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

Procedure: Surgery lumbar disc herniation
Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation
Patient without medical device DIVA®

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • SC Medica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SC Medica
ClinicalTrials.gov Identifier:
NCT05277818
Other Study ID Numbers:
  • 2021-A02667-34
First Posted:
Mar 14, 2022
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Intervertebral Disc Displacement
Hernia

Study Results

No Results Posted as of Mar 21, 2022