PMCFU of an Annular Closure System
Purpose
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.
Condition
- Lumbar Disc Herniation
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Discectomy + annular closure | All patients treated with lumbar discectomy and implantation of an annular closure device |
|
Recruiting Locations
Orthopedic Institute of Western Kentucy
Paducah, Kentucky 42001
Paducah, Kentucky 42001
More Details
- NCT ID
- NCT05467072
- Status
- Recruiting
- Sponsor
- Intrinsic Therapeutics
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.