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Comprehensive Spinal Alignment Planning Study

Spine Surgery Clinical Trial

Official title:
A Prospective Multicenter Study Evaluating the Clinical and Radiographic Outcomes of Thoracolumbar Spine Surgery When Comprehensive Sagittal Alignment Surgical Planning is Used

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02606695
Study type Observational
Source NuVasive
Contact
Status Completed
Phase
Start date March 2016
Completion date December 31, 2020
View Details
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