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

September 27, 2023 updated by: Intrinsic Therapeutics

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bielefeld, Germany, 33647
        • Wirbelsäulenzentrum Bielefeld
      • Itzehoe, Germany, 25524
        • Klinikum Itzehoe
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein
      • Lingen, Germany, 49808
        • Bonifatius Hospital Lingen
      • Steinfurt, Germany, 48565
        • UKM Marienhospital Steinfurt
  • Switzerland
      • Sankt Gallen, Switzerland, 9000
        • Orthopädie St.Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Sites will enroll all eligible patients who were implanted with the Barricaid with an anchor of the second vendor (identifiable via the lot number), and consent to participate.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients implanted with vendor B anchor
Other: Follow up per standard of care
Patients will come in 2 years post implantation and receive standard examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device failures
Time Frame: 22+ months post implantation
Device failures and movement/migration will be assessed by a radiographic core laboratory.
22+ months post implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intrinsic Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2017

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUBARD-CP-001-PMCFU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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