Lumbar Disc HerniationNCT05467072
PMCFU of an Annular Closure System
An observational study of Lumbar Disc Herniation, run by Intrinsic Therapeutics at 1 site in United States.
Trial summary
The purpose of this retrospective chart review study is to collect the data that will be used to provide clinical evidence to support the post-market surveillance program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Annular closure
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2023to Oct 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient previously treated with lumbar discectomy and annular closure, with 3 month post op follow up data available
Who may be able to join
- Records for any subject treated with a Barricaid annular closure device will be considered for inclusion into the study
Who cannot join
- Records for any subject treated without a Barricaid annular closure device will be considered for exclusion
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Orthopedic Institute of Western Kentucy
Paducah, Kentucky, 42001
Rebekah Vinson, 270-442-9461, RVinson@orthopaedicinstitute.com
K. Brandon Strenge, MD
About this study
Official title: Post-Marketing Clinical Follow-up of an Annular Closure System
The purpose of this retrospective chart review study is to collect the data that will be used to provide clinical evidence to support the post-market surveillance program.
Read the detailed description
Retrospective chart review of patients treated with lumbar discectomy and annular closure. Review of patient charts through 3 month post op, for analysis of symptomatic lumbar reherniation at the index level.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Annular closure
- 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.
Annular closureDevice
Lumbar discectomy patients treated with Annular Closure Device BARRICAID
| Study group | Role | What they receive |
|---|---|---|
| Discectomy + annular closure | All patients treated with lumbar discectomy and implantation of an annular closure device Receives: Device: Annular closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic reherniation
Reherniation of the index lumbar disc level, with patient symptoms (back or leg pain)
Measured: 3 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start27 Sep 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intrinsic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David H Kim, MD, Study chair, New England Baptist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467072
- Sponsor's protocol ID
- CP-013
- Status last verified
- Sep 2023
- First submitted
- 18 Jul 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Clinical Follow-up of an Annular Closure System
- ClinicalTrials.gov ID
- NCT05467072
- Acronym / sponsor ID
- CP-013
- Conditions
- Lumbar Disc Herniation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Intrinsic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 Jul 2022 (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.
The purpose of this retrospective chart review study is to collect the data that will be used to provide clinical evidence to support the post-market surveillance program.
Detailed description
Retrospective chart review of patients treated with lumbar discectomy and annular closure. Review of patient charts through 3 month post op, for analysis of symptomatic lumbar reherniation at the index level.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Discectomy + annular closure | – | Device: Annular closureAll patients treated with lumbar discectomy and implantation of an annular closure device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient previously treated with lumbar discectomy and annular closure, with 3 month post op follow up data available
Key inclusion criteria (1 listed)
- Records for any subject treated with a Barricaid annular closure device will be considered for inclusion into the study
Key exclusion criteria (1 listed)
- Records for any subject treated without a Barricaid annular closure device will be considered for exclusion
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 |
|---|---|---|
| Annular closureLumbar discectomy patients treated with Annular Closure Device BARRICAID | Device | Discectomy + annular closure |
Primary outcome
Symptomatic reherniation
Time frame: 3 months post op
Reherniation of the index lumbar disc level, with patient symptoms (back or leg pain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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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.
David H Kim, MD study chair
New England Baptist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation, run by Intrinsic Therapeutics at 1 site in United States.
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 1 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 29 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 1 site in United States. 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?
Contact Kelsey A Miller-Torchia, BA (7819320222 ext. 132, kmiller@in-thera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic reherniation (time frame: 3 months post op). 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 29 Sep 2023.