Value of 3D Modeling in Spine Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Value of 3D Modeling in Spine Surgery

Conditions
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Scoliosis

Intervention / Treatment
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* Device: spineEOS software
* Device: EOS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EOS + spineEOS software in adults<br>Participants will receive standard of care (EOS) - 2D planning with 3D modeling. | Device: spineEOS software<br>* 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.<br>* Other names: spineEOS workstation;Device: EOS<br>* The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.<br>* Other names: 2D Planning;|
| Active Comparator: EOS in adults<br>Participants will receive standard of care (EOS) - 2D planning performed with current practice. | Device: EOS<br>* The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.<br>* Other names: 2D Planning;|
| Experimental: EOS + spineEOS software in children<br>Participants will receive standard of care (EOS) - 2D planning with 3D modeling. | Device: spineEOS software<br>* 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.<br>* Other names: spineEOS workstation;Device: EOS<br>* The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.<br>* Other names: 2D Planning;|
| Active Comparator: EOS in children<br>Participants will receive standard of care (EOS) - 2D planning performed with current practice. | Device: EOS<br>* The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.<br>* Other names: 2D Planning;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Related Quality Of Life (HRQOL) score | The standardized questionnaire used in the clinic. | Pre-op, 3-4 months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imaging, Three-Dimensional, Spine, Scoliosis