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 Details — Status: Completed

Administrative data

• NCT number: NCT02606695
• Other study ID #: NUVA.IGA1503
• Status: Completed
• Start date: March 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2021
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spine Surgery

Intervention

Device:
• NuvaMap O.R.
Clinical imaging software used to assess intraoperative spinal alignment
• NuvaMap
Clinical imaging software used to assess spinal alignment

Locations

Country	Name	City	State
United States	Jacobs Institute/UB Neurosurgery, Inc.,	Amherst	New York
United States	Augusta Orthopedic & Sports Medicine Specialists	Augusta	Georgia
United States	Carolina Neurosurgery & Spine Associates (CNSA)	Charlotte	North Carolina
United States	Spine Colorado	Durango	Colorado
United States	Duke University	Durham	North Carolina
United States	Spine Center at Great Neck	Great Neck	New York
United States	Scripps Clinic Medical Group	La Jolla	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Rezin Orthopedics and Sports Medicine	Morris	Illinois
United States	Dupage Medical Group Spine Institute	Naperville	Illinois
United States	Orthopaedic Specialty Institute (OSI)	Orange	California
United States	Carilion Clinic (Roanoke)	Roanoke	Virginia
United States	Neurosurgical Medical Clinic, Inc.	San Diego	California
United States	Foundation for Orthopaedic Research and Education	Tampa	Florida
United States	University Spine Center	Wayne	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the utility of alignment planning using surgical planning software	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.	Postoperative (3 months)

External Links

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