Post-Marketing Clinical Follow-Up of a Spine Implant

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03180749

Acronym

PMCFU

Enrollment

Registered

2017-06-08

Start date

2017-03-02

Completion date

2024-09-30

Last updated

2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Annular Tear of Lumbar Disc, Lumbar Disc Herniation

Brief 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

Detailed 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.

Interventions

OTHERFollow up per standard of care

Patients will come in 2 years post implantation and receive standard examinations

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026