Study Stopped
Sponsor and PI decision
Value of 3D Modeling in Spine Surgery
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2016
CompletedFirst Submitted
Initial submission to the registry
May 7, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedResults Posted
Study results publicly available
July 31, 2024
CompletedJuly 31, 2024
July 1, 2024
4.4 years
May 7, 2016
December 28, 2020
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Questionnaire Showing the 3D Imaging Helped Surgery Planning
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.
1 week post-operatively
Secondary Outcomes (1)
Health Related Quality Of Life (HRQOL) Score
3-4 months post-op
Study Arms (4)
EOS + spineEOS software in adults
EXPERIMENTALParticipants will receive standard of care (EOS) - 2D planning with 3D modeling.
EOS in adults
ACTIVE COMPARATORParticipants will receive standard of care (EOS) - 2D planning performed with current practice.
EOS + spineEOS software in children
EXPERIMENTALParticipants will receive standard of care (EOS) - 2D planning with 3D modeling.
EOS in children
ACTIVE COMPARATORParticipants will receive standard of care (EOS) - 2D planning performed with current practice.
Interventions
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.
The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Diagnosis of scoliosis other than degenerative or idiopathic (i.e., paralytic/neuromuscular, congenital)
- Undergoing revision (fusion or instrumentation)
- 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 --
- All patients must be younger than 18 at the time of surgery
- Having a primary surgery of their spine (fusion or instrumentation)
- Diagnosis of scoliosis other than degenerative or idiopathic (i.e., paralytic/neuromuscular, congenital
- Undergoing revision (fusion or instrumentation)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- EOS imaging Inc.collaborator
Study Sites (1)
Columbia University Medical Center
New York, New York, 10034, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The PI and sponsor decided to end the study early because the spineEOS software did not seem to make a difference in surgery planning.
Results Point of Contact
- Title
- Dr. Lawrence Lenke
- Organization
- Columbia University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence G Lenke, MD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Orthopedic Surgery at the Columbia University Medical Center
Study Record Dates
First Submitted
May 7, 2016
First Posted
May 13, 2016
Study Start
April 19, 2016
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
July 31, 2024
Results First Posted
July 31, 2024
Record last verified: 2024-07