PMCFU of an Annular Closure System

Recruiting

• Conditions: Lumbar Disc Herniation

• Registration Number: NCT05467072
• Lead Sponsor: Intrinsic Therapeutics

Brief 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.

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 Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-20
• Status Verified: 2023-09
• Study Start: 2023-09-27
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic reherniation	3 months post op	Reherniation of the index lumbar disc level, with patient symptoms (back or leg pain)

Trial Locations

Locations (1)

Orthopedic Institute of Western Kentucy; 🇺🇸 Paducah, Kentucky, United States