Post-Marketing Clinical Follow-Up of a Spine Implant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-02

Study Completion Date

2024-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lumbar Disc Herniation Annular Tear of Lumbar Disc

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients implanted with vendor B anchor

Follow up per standard of care

Intervention Type OTHER

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

Interventions

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Follow up per standard of care

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

Intervention Type OTHER

Eligibility Criteria

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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.