PMCFU of an Annular Closure System

Last updated: September 27, 2023
Sponsor: Intrinsic Therapeutics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spondylolisthesis

Radiculopathy

Treatment

Annular closure

Clinical Study ID

NCT05467072
CP-013
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Annular closure
Phase:
Study Start date:
September 27, 2023
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • Orthopedic Institute of Western Kentucy

    Paducah, Kentucky 42001
    United States

    Active - Recruiting

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