NCT05467072

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 27, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

July 18, 2022

Last Update Submit

September 27, 2023

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

  • Symptomatic reherniation

    Reherniation of the index lumbar disc level, with patient symptoms (back or leg pain)

    3 months post op

Study Arms (1)

Discectomy + annular closure

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

Device: Annular closure

Interventions

Annular closureDEVICE

Lumbar discectomy patients treated with Annular Closure Device BARRICAID

Discectomy + annular closure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient previously treated with lumbar discectomy and annular closure, with 3 month post op follow up data available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Institute of Western Kentucy

Paducah, Kentucky, 42001, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • David H Kim, MD

    New England Baptist Hospital

    STUDY CHAIR

Central Study Contacts

Kelsey A Miller-Torchia, BA

CONTACT

7819320222kmiller@in-thera.com

Ivan Grzan, BS

CONTACT

7819320222ivan@in-thera.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 20, 2022

Study Start

September 27, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

US(1)