PMCFU of an Annular Closure System

NCT ID: NCT05467072

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-27

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Lumbar Disc Herniation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Discectomy + annular closure

All patients treated with lumbar discectomy and implantation of an annular closure device

Annular closure

Intervention Type DEVICE

Lumbar discectomy patients treated with Annular Closure Device BARRICAID

Interventions

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Annular closure

Lumbar discectomy patients treated with Annular Closure Device BARRICAID

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intrinsic Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David H Kim, MD

Role: STUDY_CHAIR

New England Baptist Hospital

Locations

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Orthopedic Institute of Western Kentucy

Paducah, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kelsey A Miller-Torchia, BA

Role: CONTACT

7819320222 ext. 132

Ivan Grzan, BS

Role: CONTACT

7819320222

Facility Contacts

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Rebekah Vinson

Role: primary

270-442-9461

Other Identifiers

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CP-013

Identifier Type: -

Identifier Source: org_study_id

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