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NCT05467072 Clinical Trial

PMCFU of an Annular Closure System

Lumbar Disc Herniation Clinical Trial

Official title:
Post-Marketing Clinical Follow-up of an Annular Closure System

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05467072
Other study ID # CP-013
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 27, 2023
Est. completion date October 2025

Study information
Verified date September 2023
Source Intrinsic Therapeutics
Contact Kelsey A Miller-Torchia, BA
Phone 7819320222
Email kmiller@in-thera.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date October 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Annular closure
Lumbar discectomy patients treated with Annular Closure Device BARRICAID

Locations
Country Name City State
United States Orthopedic Institute of Western Kentucy Paducah Kentucky

Sponsors (1)
Lead Sponsor Collaborator
Intrinsic Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptomatic reherniation Reherniation of the index lumbar disc level, with patient symptoms (back or leg pain) 3 months post op
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