Value of 3D Modeling in Spine Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 10 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02771899
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Columbia University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lawrence G Lenke, MD
Principal Investigator Affiliation Columbia University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scoliosis
Additional Details

The biplanar low-dose EOS system and its associated spineEOS workstation (EOSĀ®, 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.

Arms & Interventions

Arms

Experimental: EOS + spineEOS software in adults

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

Active Comparator: EOS in adults

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

Experimental: EOS + spineEOS software in children

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

Active Comparator: EOS in children

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

Interventions

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10034

Site Contact

Lawrence Lenke, MD

[email protected]

212-305-5974