Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-01 @ 7:34 AM
Study NCT ID:
NCT01491568
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2011-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
rhBMP-2/CRM/CD HORIZON® Spinal System Pilot Study (2-Level)
Sponsor:
Medtronic Spinal and Biologics
Organization:
Study Overview
Official Title:
Pilot Study of Recombinant Human Bone Morphogenetic Protein-2 and Compression Resistant Matrix With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic DDD at Two Adjacent Vertebral Levels
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the feasibility of using the investigational implant (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral lumbar spinal fusion at two adjacent treatment levels in patients with symptomatic degenerative disc disease.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: