Value of 3D Modeling in Spine Surgery

July 9, 2024 updated by: Lawrence Lenke, Columbia University
Adults (18 years and over) and children (10-17 years of age) scheduled for surgery to correct scoliosis will be included in this study, for which participation will last 6 months. Each age group of participants will be randomized to two cohorts: one cohort will receive standard of care, while the other will also have their standard radiographic images used in the construction of a three-dimensional visualization of the spine. Questionnaires administered before and after surgery, in addition to health information collected throughout the course of the study, will indicate whether the three-dimensional model has an effect on the planning, performance, and outcomes of surgery. Participants in this study will not be asked to do anything outside the standard of care. The only manipulated variable in this study is the construction of the three dimensional model, which is made from information collected during the standard of care, and requires no further action on the participant's behalf. The results of this study may show that three-dimensional visualizations can be of value to spinal surgeons, and positively affect patient outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The biplanar low-dose EOS system and its associated spineEOS workstation (EOS®, EOS Imaging, Paris, France) allows 3D spine reconstructions. The EOS system presents some advantages over MRI or CT Scans. The weight bearing position allows assessment in the functional position and the radiation exposure is 800-1000 times less then CT scans, allowing full spine acquisition even in pediatric patients. Selected anatomical landmarks are utilized to reconstruct a 3D model of the spine allowing global assessment as well as localized analysis.The aim of the study is to assess the clinical relevance of 3D stereographic reconstructions (from spineEOS 3D) on patients, adults and children, who undergo spine surgery. This study will observe the value of 3D parameters at three different steps of the standard of care surgical procedure: preoperatively, peri-operatively, and post-operatively. The goal of this prospective study is to observe how 3D reconstructions could enhance the planning, the surgery and the post-op analysis and outcomes. This pilot study could help to understand which and how 3D parameters could improve adult and pediatric spine surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10034
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 76 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Adults --

Inclusion Criteria:

  • All patients must be age 18 or greater at the time of surgery or initial consultation
  • Having a primary surgery of their spine (fusion or instrumentation)

Exclusion Criteria:

  • Diagnosis of scoliosis other than degenerative or idiopathic (i.e., paralytic/neuromuscular, congenital)
  • Undergoing revision (fusion or instrumentation)

EOS Exclusion Criteria:

  • Patients with supernumerary vertebrae (one extra or one less thoracic or lumbar vertebrae)
  • Insufficient quality of images to perform the 3D modeling with spineEOS software

Children --

Inclusion Criteria:

  • All patients must be younger than 18 at the time of surgery
  • Having a primary surgery of their spine (fusion or instrumentation)

Exclusion Criteria:

  • Diagnosis of scoliosis other than degenerative or idiopathic (i.e., paralytic/neuromuscular, congenital
  • Undergoing revision (fusion or instrumentation)

EOS Exclusion Criteria:

  • Patients with supernumerary vertebrae (one extra or one less thoracic or lumbar vertebrae)
  • Insufficient quality of images to perform the 3D modeling with spineEOS software

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EOS + spineEOS software in adults
Participants will receive standard of care (EOS) - 2D planning with 3D modeling.
Device: spineEOS software
During a full-length exam from head to feet in the standing position, 3D reconstructions of the spine, the pelvis and lower extremities using spine workflow and global postural assessment workflow on spineEOS software will be performed.
Other Names:
  • 3D spine reconstructions
  • 3D Modeling
  • spineEOS workstation
Device: EOS
The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.
Other Names:
  • biplanar low-dose EOS system
  • 2D Planning
Active Comparator: EOS in adults
Participants will receive standard of care (EOS) - 2D planning performed with current practice.
Device: EOS
The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.
Other Names:
  • biplanar low-dose EOS system
  • 2D Planning
Experimental: EOS + spineEOS software in children
Participants will receive standard of care (EOS) - 2D planning with 3D modeling.
Device: spineEOS software
During a full-length exam from head to feet in the standing position, 3D reconstructions of the spine, the pelvis and lower extremities using spine workflow and global postural assessment workflow on spineEOS software will be performed.
Other Names:
  • 3D spine reconstructions
  • 3D Modeling
  • spineEOS workstation
Device: EOS
The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.
Other Names:
  • biplanar low-dose EOS system
  • 2D Planning
Active Comparator: EOS in children
Participants will receive standard of care (EOS) - 2D planning performed with current practice.
Device: EOS
The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.
Other Names:
  • biplanar low-dose EOS system
  • 2D Planning

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Questionnaire Showing the 3D Imaging Helped Surgery Planning
Time Frame: 1 week post-operatively
The surgeon will complete a one-question surgical questionnaire regarding their perceptions of the value of 3D modeling brought to the care of their patient. "Did the 3D imaging help with planning the surgery?" Yes = it helped. No = it did not help.
1 week post-operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health Related Quality Of Life (HRQOL) Score
Time Frame: 3-4 months post-op
The standardized Scoliosis Research Society-22r questionnaire consists of 22 questions that assesses the patient's physical function, pain, self-image, mental health, and satisfaction with treatment. The minimum score is 22 and the highest score is 110. A higher score indicates a better outcome.
3-4 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
EOS imaging Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lawrence G Lenke, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAQ6551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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