NCT03986580

Study of Lumbar Discectomy With Annular Closure

Prospective Evaluation Of Lumbar Discectomy With Additional Implantation Of An Annular Closure Device In Patients With Large Postsurgical Annular Defects For Prevention Of Lumbar Disc Reherniation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Intrinsic Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lumbar Disc Herniation

Interventions

Type	Name	Description
DEVICE	Annular closure device	Annular closure, following limited discectomy procedure at a single LS level between L4 and S1

Timeline

• Start date: 2020-05-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2019-06-14
• Last updated: 2023-09-28

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study