Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03404232
Status:
COMPLETED
Last Update Posted:
2018-01-19
First Post:
2018-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial
Sponsor:
University Hospital, Aachen
Organization:
Study Overview
Official Title:
The Use of the DTO Hybrid Dynamic Device: a Clinical Outcome- and Radiological-based Prospective Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-01
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 study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting.
Detailed Description:
Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation of the superiorly adjacent segment (Dynesys DTO).
Planned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.
Planned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: