Post-Marketing Clinical Follow-Up of a Spine Implant

Intrinsic Therapeutics90 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lumbar Disc Herniation Annular Tear of Lumbar Disc

Interventions

Follow up per standard of careOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Wirbelsäulenzentrum Bielefeld

Bielefeld, Germany

Klinikum Itzehoe

Itzehoe, Germany

Universitaetsklinikum Schleswig-Holstein

Kiel, Germany

Bonifatius Hospital Lingen

Lingen, Germany

Outcomes

Primary Outcomes

Device failures

Device failures and movement/migration will be assessed by a radiographic core laboratory.

Time frame: 22+ months post implantation

Data from ClinicalTrials.gov

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