PMCFU of an Annular Closure System

September 27, 2023 updated by: Intrinsic Therapeutics

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Recruiting
        • Orthopedic Institute of Western Kentucy
        • Principal Investigator:
          • K. Brandon Strenge, MD
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient previously treated with lumbar discectomy and annular closure, with 3 month post op follow up data available

Description

Inclusion Criteria:

  • Records for any subject treated with a Barricaid annular closure device will be considered for inclusion into the study

Exclusion Criteria:

  • Records for any subject treated without a Barricaid annular closure device will be considered for exclusion

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Discectomy + annular closure
All patients treated with lumbar discectomy and implantation of an annular closure device
Device: Annular closure
Lumbar discectomy patients treated with Annular Closure Device BARRICAID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic reherniation
Time Frame: 3 months post op
Reherniation of the index lumbar disc level, with patient symptoms (back or leg pain)
3 months post op

Collaborators and Investigators

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

Sponsor

Intrinsic Therapeutics

Investigators

  • Study Chair: David H Kim, MD, New England Baptist Hospital

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)

September 27, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 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

  • CP-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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