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Value of 3D Modeling in Spine Surgery

Primary Purpose

Scoliosis

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

spineEOS software

EOS

About this trial

This is an interventional diagnostic trial for Scoliosis focused on measuring Imaging, Three-Dimensional, Spine, Scoliosis

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Columbia University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

EOS + spineEOS software in adults

EOS in adults

EOS + spineEOS software in children

EOS in children

Arm Description

Participants will receive standard of care (EOS) - 2D planning with 3D modeling.

Participants will receive standard of care (EOS) - 2D planning performed with current practice.

Participants will receive standard of care (EOS) - 2D planning with 3D modeling.

Participants will receive standard of care (EOS) - 2D planning performed with current practice.

Outcomes

Primary Outcome Measures

Surgical questionnaire score

The surgeon will complete a surgical questionnaire regarding their perceptions of the value of 3D modeling brought to the care of their patient.

Secondary Outcome Measures

Change in Health Related Quality Of Life (HRQOL) score

The standardized questionnaire used in the clinic.

Full Information

NCT ID

NCT02771899

First Posted

May 7, 2016

Last Updated

March 22, 2019

Sponsor

Columbia University

Collaborators

EOS imaging Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02771899

Brief Title

Value of 3D Modeling in Spine Surgery

Official Title

Value of 3D Modeling in Spine Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (Actual)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

EOS imaging Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scoliosis

Keywords

Imaging, Three-Dimensional, Spine, Scoliosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EOS + spineEOS software in adults

Arm Type

Experimental

Arm Description

Participants will receive standard of care (EOS) - 2D planning with 3D modeling.

Arm Title

EOS in adults

Arm Type

Active Comparator

Arm Description

Participants will receive standard of care (EOS) - 2D planning performed with current practice.

Arm Title

EOS + spineEOS software in children

Arm Type

Experimental

Arm Description

Participants will receive standard of care (EOS) - 2D planning with 3D modeling.

Arm Title

EOS in children

Arm Type

Active Comparator

Arm Description

Participants will receive standard of care (EOS) - 2D planning performed with current practice.

Intervention Type

Device

Intervention Name(s)

spineEOS software

Other Intervention Name(s)

3D spine reconstructions, 3D Modeling, spineEOS workstation

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

EOS

Other Intervention Name(s)

biplanar low-dose EOS system, 2D Planning

Intervention Description

The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.

Primary Outcome Measure Information:

Title

Surgical questionnaire score

Description

The surgeon will complete a surgical questionnaire regarding their perceptions of the value of 3D modeling brought to the care of their patient.

Time Frame

1 week post-operatively

Secondary Outcome Measure Information:

Title

Change in Health Related Quality Of Life (HRQOL) score

Description

The standardized questionnaire used in the clinic.

Time Frame

Pre-op, 3-4 months post-op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lawrence R Lenke, MD

Phone

212-305-5974

ll2989@columbia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Meghan Cerpa

mc4338@cumc.columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lawrence G Lenke, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10034

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lawrence Lenke, MD

Phone

212-305-5974

ll2989@columbia.edu

First Name & Middle Initial & Last Name & Degree

G Lenke, MD

First Name & Middle Initial & Last Name & Degree

Lawrence G Lenke, MD

12. IPD Sharing Statement

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Value of 3D Modeling in Spine Surgery

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