Post-Marketing Clinical Follow-Up of a Spine Implant
Active, not recruiting
- Conditions
- Annular Tear of Lumbar DiscLumbar Disc Herniation
- Interventions
- Other: Follow up per standard of care
- 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.
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
- Arm && Interventions
Group Intervention Description Patients implanted with vendor B anchor Follow up per standard of care -
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Orthopädie St.Gallen
🇨🇭Sankt Gallen, Switzerland
Wirbelsäulenzentrum Bielefeld
🇩🇪Bielefeld, Germany
Universitaetsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Klinikum Itzehoe
🇩🇪Itzehoe, Germany
Bonifatius Hospital Lingen
🇩🇪Lingen, Germany
UKM Marienhospital Steinfurt
🇩🇪Steinfurt, Germany