Spine Surgery
Conditions
Keywords
Spine Surgery Patients
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.
Interventions
DEVICENuvaMap O.R.
Clinical imaging software used to assess intraoperative spinal alignment
DEVICENuvaMap
Clinical imaging software used to assess spinal alignment
Sponsors
NuVasive
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the utility of alignment planning using surgical planning software | 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. |
Countries
United States
Outcome results
None listed