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NCT03180749 Clinical Trial

Post-Marketing Clinical Follow-Up of a Spine Implant

Lumbar Disc Herniation Clinical Trial

— PMCFU  

Official title:
Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome Between Devices With Subcomponents From Two Different Suppliers

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03180749
Other study ID # EUBARD-CP-001-PMCFU
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 2, 2017
Est. completion date September 2024

Study information
Verified date September 2023
Source Intrinsic Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers

Description:

Comparison of device integrity (anchor fracture and/or mesh detachment) and device movement/migration in patients implanted with the Barricaids with anchors from two different suppliers.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 90
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Each site will enroll all patients who were implanted with a Barricaid with an anchor manufactured by the second manufacturer. - Patients must be 18 years of age or older and able to understand and consent to participate in the study. Exclusion Criteria: - Not defined

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Follow up per standard of care
Patients will come in 2 years post implantation and receive standard examinations

Locations
Country Name City State
Germany Wirbelsäulenzentrum Bielefeld Bielefeld
Germany Klinikum Itzehoe Itzehoe
Germany Universitaetsklinikum Schleswig-Holstein Kiel
Germany Bonifatius Hospital Lingen Lingen
Germany UKM Marienhospital Steinfurt Steinfurt
Switzerland Orthopädie St.Gallen Sankt Gallen

Sponsors (1)
Lead Sponsor Collaborator
Intrinsic Therapeutics

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Device failures Device failures and movement/migration will be assessed by a radiographic core laboratory. 22+ months post implantation
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