PMCFU of an Annular Closure System

Intrinsic Therapeutics

Status: Enrolling

Conditions: Lumbar Disc Herniation

Treatments: Device: Annular closure

Study type: Observational

Funder types: Industry

Identifiers

NCT05467072

CP-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Discectomy + annular closure

Description:

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

Treatment:

Device: Annular closure