MedTrace Logo

Value of 3D Modeling in Spine Surgery

NCT02771899 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-07-31

Study results available
· View outcomes & findings →

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.

Conditions

  • Scoliosis

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.

Sponsors & Collaborators

Principal Investigators

  • Lawrence G Lenke, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-19
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02771899 on ClinicalTrials.gov