Post-Marketing Clinical Follow-Up of a Spine Implant (PMCFU)

Intrinsic Therapeutics

Status: Active, not recruiting

Conditions: Annular Tear of Lumbar Disc; Lumbar Disc Herniation

Treatments: Other: Follow up per standard of care

Study type: Observational

Funder types: Industry

Identifiers

NCT03180749

EUBARD-CP-001-PMCFU

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

90 participants in 1 patient group

Patients implanted with vendor B anchor

Treatment:

Other: Follow up per standard of care