Recruiting

Observational Study

Sponsor:

Intrinsic Therapeutics

Code:

NCT05467072

Conditions

Lumbar Disc Herniation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Annular closure

Study Details

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.

Conditions

Lumbar Disc Herniation

Study ID

NCT05467072

Start date

Sep 27, 2023

Status verified date

Sep, 2023

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Discectomy + annular closure

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

Interventions

Annular closure

Lumbar discectomy patients treated with Annular Closure Device BARRICAID

Primary outcome measure

  • Symptomatic reherniation [ Time Frame: 3 months post op ]

Central Contacts and Locations

Central contacts

Kelsey A Miller-Torchia, BA

7819320222kmiller@in-thera.com

Ivan Grzan, BS

7819320222ivan@in-thera.com

Locations

Orthopedic Institute of Western Kentucy

Recruiting

Paducah, Kentucky, United States, 42001

Contacts

Rebekah Vinson

270-442-9461RVinson@orthopaedicinstitute.com

Principal Investigator:

K. Brandon Strenge, MD

More Information

Sponsor

Intrinsic Therapeutics

Last update posted

Sep 29, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Intrinsic Therapeutics on 2023-09-29.