Spine SurgeryNCT02606695
Comprehensive Spinal Alignment Planning Study
An observational study of Spine Surgery, run by NuVasive at 15 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery
- What is being tested?
- NuvaMap O.R. and NuvaMap
- Type of treatment
- Medical device
- How many people
- 306 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male and female patients who are at least 18 years of age;
- 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;
- Able to undergo surgery based on physical exam, medical history and surgeon judgment;
- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation.
Who cannot join
- Patient has a mental or physical condition that would limit the ability to comply with study requirements;
- Patient is a prisoner;
- Patient is participating in another clinical study that would confound study data.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Jacobs Institute/UB Neurosurgery, Inc.,
Amherst, New York, 14226
Augusta Orthopedic & Sports Medicine Specialists
Augusta, Georgia, 30909
Carolina Neurosurgery & Spine Associates (CNSA)
Charlotte, North Carolina, 28204
Spine Colorado
Durango, Colorado, 81301
Duke University
Durham, North Carolina, 27710
Spine Center at Great Neck
Great Neck, New York, 11021
Scripps Clinic Medical Group
La Jolla, California, 92037
University of Minnesota
Minneapolis, Minnesota, 55455
Rezin Orthopedics and Sports Medicine
Morris, Illinois, 60450
Dupage Medical Group Spine Institute
Naperville, Illinois, 60540
Orthopaedic Specialty Institute (OSI)
Orange, California, 92868
Carilion Clinic (Roanoke)
Roanoke, Virginia, 24013
Neurosurgical Medical Clinic, Inc.
San Diego, California, 92123
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33637
University Spine Center
Wayne, New Jersey, 07470
About this 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
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.
Read the 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.
- Conditions
- Spine Surgery
- Being tested
- NuvaMap O.R., NuvaMap
- Keywords
- Spine Surgery Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuvaMap O.R.Device
Clinical imaging software used to assess intraoperative spinal alignment
NuvaMapDevice
Clinical imaging software used to assess spinal alignment
| Study group | Role | What they receive |
|---|---|---|
| NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion | Not described Receives: Device: NuvaMap O.R.; Device: NuvaMap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startMar 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606695
- Sponsor's protocol ID
- NUVA.IGA1503
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2015
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study Evaluating the Clinical and Radiographic Outcomes of Thoracolumbar Spine Surgery When Comprehensive Sagittal Alignment Surgical Planning is Used
- ClinicalTrials.gov ID
- NCT02606695
- Acronym / sponsor ID
- NUVA.IGA1503
- Conditions
- Spine Surgery
- Keywords
- Spine Surgery Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion | – | Device: NuvaMap O.R., Device: NuvaMap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Male and female patients who are at least 18 years of age;
- 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;
- Able to undergo surgery based on physical exam, medical history and surgeon judgment;
- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation.
Key exclusion criteria (3 listed)
- Patient has a mental or physical condition that would limit the ability to comply with study requirements;
- Patient is a prisoner;
- Patient is participating in another clinical study that would confound study data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuvaMap O.R.Clinical imaging software used to assess intraoperative spinal alignment | Device | NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion |
| NuvaMapClinical imaging software used to assess spinal alignment | Device | NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion |
Primary outcome
Evaluate the utility of alignment planning using surgical planning software
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Recruiting
Evaluation of the Statistical Validity of Cervical Spine Measurements-Including Range of Motion, Strength, and Functional Test Results-for Return to Sport in Patients Who Have Undergone Surgery for Cervical Stenosis and/or Herniation.
Cervical Stenosis, Cervical Spine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Surgery, run by NuVasive at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the utility of alignment planning using surgical planning software (time frame: Postoperative (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.