Value of 3D Modeling in Spine Surgery

Not Applicable

Terminated

• Conditions: Scoliosis
• Interventions: Device: spineEOS software; Device: EOS

• Registration Number: NCT02771899
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2016-04-19
• Study First Submitted: 2016-05-07
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-13
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Results First Submitted: 2020-12-28
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Results First Posted: 2024-07-31
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EOS + spineEOS software in children	EOS	Participants will receive standard of care (EOS) - 2D planning with 3D modeling.
EOS + spineEOS software in adults	spineEOS software	Participants will receive standard of care (EOS) - 2D planning with 3D modeling.
EOS in children	EOS	Participants will receive standard of care (EOS) - 2D planning performed with current practice.
EOS + spineEOS software in adults	EOS	Participants will receive standard of care (EOS) - 2D planning with 3D modeling.
EOS in adults	EOS	Participants will receive standard of care (EOS) - 2D planning performed with current practice.
EOS + spineEOS software in children	spineEOS software	Participants will receive standard of care (EOS) - 2D planning with 3D modeling.

Primary Outcome Measures

Name	Time	Method
Questionnaire Showing the 3D Imaging Helped Surgery Planning	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.

Secondary Outcome Measures

Name	Time	Method
Health Related Quality Of Life (HRQOL) Score	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States