NCT02606695

Comprehensive Spinal Alignment Planning Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 306 (actual)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spine Surgery

Interventions

Type	Name	Description
DEVICE	NuvaMap O.R.	Clinical imaging software used to assess intraoperative spinal alignment
DEVICE	NuvaMap	Clinical imaging software used to assess spinal alignment

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2015-11-17
• Last updated: 2025-12-22

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study