Comprehensive Spinal Alignment Planning Study

Completed

• Conditions: Spine Surgery

• Registration Number: NCT02606695
• Lead Sponsor: NuVasive

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.

Study Timeline

• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-17
• Study Start: 2016-03
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (15)

Scripps Clinic Medical Group; 🇺🇸 La Jolla, California, United States

Orthopaedic Specialty Institute (OSI); 🇺🇸 Orange, California, United States

Neurosurgical Medical Clinic, Inc.; 🇺🇸 San Diego, California, United States

Spine Colorado; 🇺🇸 Durango, Colorado, United States

Foundation for Orthopaedic Research and Education; 🇺🇸 Tampa, Florida, United States

Augusta Orthopedic & Sports Medicine Specialists; 🇺🇸 Augusta, Georgia, United States

Rezin Orthopedics and Sports Medicine; 🇺🇸 Morris, Illinois, United States

Dupage Medical Group Spine Institute; 🇺🇸 Naperville, Illinois, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University Spine Center; 🇺🇸 Wayne, New Jersey, United States

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