Post-Marketing Clinical Follow-Up of a Spine Implant

Active, not recruiting

• Conditions: Annular Tear of Lumbar Disc; Lumbar Disc Herniation

• Registration Number: NCT03180749
• Lead Sponsor: Intrinsic Therapeutics

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.

Study Timeline

• Study Start: 2017-03-02
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-06
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (6)

Wirbelsäulenzentrum Bielefeld; 🇩🇪 Bielefeld, Germany

Klinikum Itzehoe; 🇩🇪 Itzehoe, Germany

Universitaetsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Bonifatius Hospital Lingen; 🇩🇪 Lingen, Germany

UKM Marienhospital Steinfurt; 🇩🇪 Steinfurt, Germany

Orthopädie St.Gallen; 🇨🇭 Sankt Gallen, Switzerland