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

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

54

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Columbia University

Collaborators

EOS imaging Inc.

Investigators

  • 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)

April 19, 2016

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

May 7, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimated)

May 13, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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