Review of patients treated with an annular closure system for lumbar disc herniation
Post-Marketing Clinical Follow-up of an Annular Closure System
This study looks at patients who had surgery for a herniated disc using a special device to see if it helps prevent the disc from bulging out again within three months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | Intrinsic Therapeutics Industry-sponsored |
| Locations | 1 site (Paducah, Kentucky) |
| Trial ID | NCT05467072 on ClinicalTrials.gov |
What this trial studies
This observational study involves a retrospective chart review of patients who underwent lumbar discectomy with the use of a Barricaid annular closure device. The aim is to collect data on the outcomes of these patients, specifically focusing on the incidence of symptomatic lumbar reherniation at the index level within three months post-operation. By analyzing patient records, the study seeks to provide clinical evidence to support the post-market surveillance program for the annular closure system.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have undergone lumbar discectomy and received a Barricaid annular closure device.
Not a fit: Patients who were treated without the Barricaid annular closure device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the annular closure system in reducing reherniation rates, potentially improving patient outcomes.
How similar studies have performed: While this study is focused on post-market surveillance, similar approaches in evaluating surgical interventions have shown success in providing critical data for device efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paducah, Kentucky
- Orthopedic Institute of Western Kentucy — Paducah, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Kelsey A Miller-Torchia, BA
- Email: kmiller@in-thera.com
- Phone: 7819320222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.