NCT03180749

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

7.3 years

First QC Date

June 6, 2017

Last Update Submit

September 27, 2023

Conditions

Lumbar Disc HerniationAnnular Tear of Lumbar Disc

Outcome Measures

Primary Outcomes (1)

  • Device failures

    Device failures and movement/migration will be assessed by a radiographic core laboratory.

    22+ months post implantation

Study Arms (1)

Patients implanted with vendor B anchor

Other: Follow up per standard of care

Interventions

Follow up per standard of careOTHER

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

Patients implanted with vendor B anchor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Not defined

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Wirbelsäulenzentrum Bielefeld

Bielefeld, 33647, Germany

Location

Klinikum Itzehoe

Itzehoe, 25524, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Bonifatius Hospital Lingen

Lingen, 49808, Germany

Location

UKM Marienhospital Steinfurt

Steinfurt, 48565, Germany

Location

Orthopädie St.Gallen

Sankt Gallen, 9000, Switzerland

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 8, 2017

Study Start

March 2, 2017

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

CH(1)DE(5)