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

October 27, 2022 updated by: SC Medica

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

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

822

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with the DIVA® device operated in the study centers for at least 12 months (with the exception of the first 30 operated by practitioner, to take into account the learning curve), as well as all patients operated on over a period similar before the installation of DIVA® in the establishment, will receive the information note of the study. if the patient agrees to participate to the study, patient's data will be collected on a case report form.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SC Medica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Anticipated)

March 15, 2027

Study Completion (Anticipated)

March 15, 2027

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 27, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02667-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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