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OpenTrials
Completed

NCT Number: NCT02606695

Comprehensive Spinal Alignment Planning Study

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Clinic Medical Group, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients who are at least 18 years of age;
  • Patients with planned thoracolumbar (any number of levels between T1 and the pelvis) spine fusion surgery and available preoperative standing lateral radiographs, inclusive of the femoral head axis;
  • Able to undergo surgery based on physical exam, medical history and surgeon judgment;
  • Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation.

Exclusion criteria

  • Patient has a mental or physical condition that would limit the ability to comply with study requirements;
  • Patient is a prisoner;
  • Patient is participating in another clinical study that would confound study data.

Treatment and study plan

NuvaMap O.R.

Device

Clinical imaging software used to assess intraoperative spinal alignment

NuvaMap

Device

Clinical imaging software used to assess spinal alignment

Primary outcomes

  1. Evaluate the utility of alignment planning using surgical planning software

    Time frame: Postoperative (3 months)

    The incidence of a change in plan (pre- or intraoperative) based on alignment measurement feedback, and the consequential achievement of postoperative (at 3 months) alignment relative to planned goals.

Sponsors and collaborators

Lead sponsor

NuVasive

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2015
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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