Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-03 @ 3:02 PM
Study NCT ID:
NCT02551302
Status:
UNKNOWN
Last Update Posted:
2015-09-16
First Post:
2015-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"
Sponsor:
University of Cologne
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
NOT_YET_RECRUITING
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:
BalanC
Brief Summary:
Effectiveness of hybrid systems ("topping off") compared to rigid spondylodesis in fusion surgery of the lumbar spine: A prospective, randomized, bicentric pilot study ("CD HORIZON BalanC™)
Detailed Description:
Posterior spondylodesis and monosegmental intervertebral cage plus flexible spondylodesis of the superiorly adjacent segment (CD HORIZON BalanC™ Manufacturer: Medtronic)
Control:
Posterior spondylodesis and monosegmental intervertebral cage
Control:
Posterior spondylodesis and monosegmental intervertebral cage
Study Oversight
Has Oversight DMC:
False
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?: