Clinical trial NCT02606695: Comprehensive Spinal Alignment Planning Study
Official title: A Prospective Multicenter Study Evaluating the Clinical and Radiographic Outcomes of Thoracolumbar Spine Surgery When Comprehensive Sagittal Alignment Surgical Planning is Used
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Surgery
Keywords: Spine Surgery Patients
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2015-11-17
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 300 patients will be enrolled in this multicenter observational study. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol are considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the utility of alignment planning using surgical planning software
timeFrame: Postoperative (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic Medical Group
state: California
city: Orange
country: United States
facility: Orthopaedic Specialty Institute (OSI)
state: California
city: San Diego
country: United States
facility: Neurosurgical Medical Clinic, Inc.
state: California
city: Durango
country: United States
facility: Spine Colorado
state: Colorado
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
city: Augusta
country: United States
facility: Augusta Orthopedic & Sports Medicine Specialists
state: Georgia
city: Morris
country: United States
facility: Rezin Orthopedics and Sports Medicine
state: Illinois
city: Naperville
country: United States
facility: Dupage Medical Group Spine Institute
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Wayne
country: United States
facility: University Spine Center
state: New Jersey
city: Amherst
country: United States
facility: Jacobs Institute/UB Neurosurgery, Inc.,
state: New York
city: Great Neck
country: United States
facility: Spine Center at Great Neck
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery & Spine Associates (CNSA)
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Roanoke
country: United States
facility: Carilion Clinic (Roanoke)
state: Virginia
Study officials:
References: