An interventional study of spineEOS software and EOS in Scoliosis, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Columbia University · Not applicable, Interventional, and Diagnostic
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.
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.
603 studies on the registry are indexed under Scoliosis; 141 are open to participants now.
This study's enrollment of 54 is above the median of 44 across 350 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults --
Inclusion Criteria:
Exclusion Criteria:
EOS Exclusion Criteria:
Children --
Inclusion Criteria:
Exclusion Criteria:
EOS Exclusion Criteria:
Participants will receive standard of care (EOS) - 2D planning with 3D modeling.
Device: spineEOS software · Device: EOS
Participants will receive standard of care (EOS) - 2D planning performed with current practice.
Device: EOS
Participants will receive standard of care (EOS) - 2D planning with 3D modeling.
Device: spineEOS software · Device: EOS
Participants will receive standard of care (EOS) - 2D planning performed with current practice.
Device: EOS
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.
Also known as: 3D spine reconstructions, 3D Modeling, spineEOS workstation
The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.
Also known as: biplanar low-dose EOS system, 2D Planning
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.
Time frame: 1 week post-operatively
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.
Time frame: 3-4 months post-op
| Milestone | EOS + spineEOS Software in Adults | EOS in Adults | EOS + spineEOS Software in Children | EOS in Children |
|---|---|---|---|---|
| Started | 20 | 17 | 6 | 11 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 20 | 17 | 6 | 11 |
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.
| Participants | EOS + spineEOS Software in Adults | EOS + spineEOS Software in Children |
|---|---|---|
| Yes | 0 | 0 |
| No | 7 | 4 |
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.
| score on a scale | EOS + spineEOS Software in Adults | EOS in Adults | EOS + spineEOS Software in Children | EOS in Children |
|---|---|---|---|---|
| Health Related Quality Of Life (HRQOL) Score | 103 ± 6 | — | 106 ± 3 | — |
Collected over Up to 4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EOS + spineEOS Software in Adults | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| EOS in Adults | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| EOS + spineEOS Software in Children | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| EOS in Children | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | EOS + spineEOS Software in Adults | EOS in Adults | EOS + spineEOS Software in Children | EOS in Children | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 6 | 11 | 17 |
| Between 18 and 65 years | 13 | 14 | 0 | 0 | 27 |
| >=65 years | 7 | 3 | 0 | 0 | 10 |
| Age, Continuous(years) | EOS + spineEOS Software in Adults | EOS in Adults | EOS + spineEOS Software in Children | EOS in Children | Total |
|---|---|---|---|---|---|
| Mean | 44 ± 18 | 52 ± 19.9 | 16 ± 2.8 | 16 ± 2 | 38 ± 21.7 |
| Sex: Female, Male(Participants) | EOS + spineEOS Software in Adults | EOS in Adults | EOS + spineEOS Software in Children | EOS in Children | Total |
|---|---|---|---|---|---|
| Female | 11 | 11 | 4 | 8 | 34 |
| Male | 9 | 6 | 2 | 3 | 20 |
| Race and Ethnicity Not Collected(Participants) | EOS + spineEOS Software in Adults | EOS in Adults | EOS + spineEOS Software in Children | EOS in Children | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(participants) | EOS + spineEOS Software in Adults | EOS in Adults | EOS + spineEOS Software in Children | EOS in Children | Total |
|---|---|---|---|---|---|
| United States | 20 | 17 | 6 | 11 | 54 |
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