ScoliosisNCT02771899
Value of 3D Modeling in Spine Surgery
A study testing spineEOS software and EOS in people with Scoliosis, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- spineEOS software and EOS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2016to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
- All patients must be younger than 18 at the time of surgery
- Having a primary surgery of their spine (fusion or instrumentation)
Who cannot join
- 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 --
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10034
About this study
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.
Read the 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.
- Conditions
- Scoliosis
- Being tested
- spineEOS software, EOS
- Keywords
- Imaging, Three-Dimensional, Spine, Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spineEOS softwareDevice
Also called 3D spine reconstructions, 3D Modeling, spineEOS workstation
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.
EOSDevice
Also called biplanar low-dose EOS system, 2D Planning
The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| EOS + spineEOS software in adults | Experimental | Participants will receive standard of care (EOS) - 2D planning with 3D modeling. Receives: Device: spineEOS software; Device: EOS |
| EOS in adults | Active comparator | Participants will receive standard of care (EOS) - 2D planning performed with current practice. Receives: Device: EOS |
| EOS + spineEOS software in children | Experimental | Participants will receive standard of care (EOS) - 2D planning with 3D modeling. Receives: Device: spineEOS software; Device: EOS |
| EOS in children | Active comparator | Participants will receive standard of care (EOS) - 2D planning performed with current practice. Receives: Device: EOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week post-operatively
Secondary outcomes (1)
Health Related Quality Of Life (HRQOL) Score
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.
Measured: 3-4 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start19 Apr 2016
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: Sponsor and PI decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- EOS imaging Inc.
- Responsible party
- Principal investigator, Lawrence Lenke, Columbia University
- Investigators
- Lawrence G Lenke, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771899
- Sponsor's protocol ID
- AAAQ6551
- Status last verified
- Jul 2024
- First submitted
- 7 May 2016
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of 3D Modeling in Spine Surgery
- ClinicalTrials.gov ID
- NCT02771899
- Acronym / sponsor ID
- AAAQ6551
- Conditions
- Scoliosis
- Keywords
- Imaging, Three-Dimensional, Spine, Scoliosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor and PI decision
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- EOS imaging Inc.
- Study start
- 19 Apr 2016 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EOS + spineEOS software in adults | Experimental | Device: spineEOS software, Device: EOSParticipants will receive standard of care (EOS) - 2D planning with 3D modeling. |
| EOS in adults | Active comparator | Device: EOSParticipants will receive standard of care (EOS) - 2D planning performed with current practice. |
| EOS + spineEOS software in children | Experimental | Device: spineEOS software, Device: EOSParticipants will receive standard of care (EOS) - 2D planning with 3D modeling. |
| EOS in children | Active comparator | Device: EOSParticipants will receive standard of care (EOS) - 2D planning performed with current practice. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
- All patients must be younger than 18 at the time of surgery
- Having a primary surgery of their spine (fusion or instrumentation)
Key exclusion criteria (11 listed)
- 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 --
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spineEOS softwareAlso: 3D spine reconstructions, 3D Modeling, spineEOS workstationDuring 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 + spineEOS software in adults, EOS + spineEOS software in children |
| EOSAlso: biplanar low-dose EOS system, 2D PlanningThe system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care. | Device | EOS + spineEOS software in adults, EOS + spineEOS software in children, EOS in adults, EOS in children |
Primary outcome
Questionnaire Showing the 3D Imaging Helped Surgery Planning
Time frame: 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.
1 secondary outcome
Health Related Quality Of Life (HRQOL) Score
Time frame: 3-4 months post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Scoliosis
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
Adolescent Idiopathic Scoliosis (AIS)
Active, not recruitingObservational study
Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
Adolescent Idiopathic Scoliosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence G Lenke, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spineEOS software and EOS in people with Scoliosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire Showing the 3D Imaging Helped Surgery Planning (time frame: 1 week post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024; AzTrials last refreshed its copy on 2 Nov 2026.