Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-29 @ 11:23 AM
Study NCT ID:
NCT02606695
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2015-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Spinal Alignment Planning Study
Sponsor:
NuVasive
Organization:
Study Overview
Official Title:
A Prospective Multicenter Study Evaluating the Clinical and Radiographic Outcomes of Thoracolumbar Spine Surgery When Comprehensive Sagittal Alignment Surgical Planning is Used
Status:
COMPLETED
Status Verified Date:
2025-12
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:
A comprehensive approach to the evaluation of alignment in spinal surgery patients - through preoperative planning, intraoperative assessment, and postoperative confirmation - has not been well-studied. This study aims to assess the value of such planning through clinical and radiographic outcomes.
Detailed Description:
Preoperative planning using tools such as NuvaMapTM (NuVasive®, Inc., San Diego, CA) enable a surgeon to preoperatively evaluate these alignment parameters and simulate a patient-specific plan using a combination of procedures, techniques, and implants. Once in the operating room, realignment objectives can be verified from a lateral fluoroscopic image in real-time using NuvaMap O.R. (NuVasive, Inc.), a software application integrated with the NVM5® neuromonitoring platform (NuVasive, Inc.). This real-time verification allows for confirmation and subsequent changing of the plan as necessary. The objective of this study is to validate the utility and effectiveness of comprehensive surgical planning in restoring and preserving sagittal alignment through the collection of clinical and radiographic outcomes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: