Comprehensive Spinal Alignment Planning Study

NuVasive

Status: Completed

Conditions: Spine Surgery

Treatments: Device: NuvaMap O.R.; Device: NuvaMap

Study type: Observational

Funder types: Industry

Identifiers

NCT02606695

NUVA.IGA1503

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female patients who are at least 18 years of age;
2. 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;
3. Able to undergo surgery based on physical exam, medical history and surgeon judgment;
4. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation.

Exclusion criteria

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

Trial design

306 participants in 1 patient group

NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion

Treatment:

Device: NuvaMap

Device: NuvaMap O.R.