Lumbar Disc HerniationPMCFUNCT03180749
Post-Marketing Clinical Follow-Up of a Spine Implant
An observational study of Lumbar Disc Herniation and Annular Tear of Lumbar Disc, run by Intrinsic Therapeutics at 6 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Annular Tear of Lumbar Disc
- How many people
- 90 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 2 Mar 2017to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not defined
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany5 sites
Wirbelsäulenzentrum Bielefeld
Bielefeld, 33647
Klinikum Itzehoe
Itzehoe, 25524
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105
Bonifatius Hospital Lingen
Lingen, 49808
UKM Marienhospital Steinfurt
Steinfurt, 48565
About this study
Official title: 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
Read the 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.
- Being tested
- Follow up per standard of care
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up per standard of careOther
Patients will come in 2 years post implantation and receive standard examinations
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted with vendor B anchor | Not described Receives: Other: Follow up per standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device failures
Device failures and movement/migration will be assessed by a radiographic core laboratory.
Measured: 22+ months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start2 Mar 2017
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intrinsic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180749
- Sponsor's protocol ID
- EUBARD-CP-001-PMCFU
- Acronym
- PMCFU
- Status last verified
- Sep 2023
- First submitted
- 6 Jun 2017
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome Between Devices With Subcomponents From Two Different Suppliers
- ClinicalTrials.gov ID
- NCT03180749
- Acronym / sponsor ID
- PMCFU / EUBARD-CP-001-PMCFU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Intrinsic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with vendor B anchor | – | Other: Follow up per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Not defined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow up per standard of carePatients will come in 2 years post implantation and receive standard examinations | Other | Patients implanted with vendor B anchor |
Primary outcome
Device failures
Time frame: 22+ months post implantation
Device failures and movement/migration will be assessed by a radiographic core laboratory.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Annular Tear of Lumbar Disc, run by Intrinsic Therapeutics at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device failures (time frame: 22+ months post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.