Study of Lumbar Discectomy With Annular Closure

Status Active, not recruiting

Clinical Trial Summary

The purpose of this prospective, single-arm, multicenter study is to assess an annular closure device when used as an adjunct to a primary lumbar limited discectomy, to limited discectomy alone.

Clinical Trial Description

This single-arm case series will enroll 75 patients at select US (approximately 8-10) sites. Patients that are scheduled for a single-level L4-S1 discectomy and who meet the pre-operative eligibility criteria will be considered for study participation. Patients that meet all intraoperative criteria will be enrolled into the study and treated with lumbar discectomy and additional annular closure device implantation. All enrolled subjects will be followed for at least 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03986580
Study type	Interventional
Source	Intrinsic Therapeutics
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 1, 2020
Completion date	December 2024

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