Scoliosis
Conditions
Keywords
Imaging, Three-Dimensional, Spine, Scoliosis
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.
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.
Interventions
DEVICEspineEOS 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.
DEVICEEOS
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
EOS imaging Inc.
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire Showing the 3D Imaging Helped Surgery Planning | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality Of Life (HRQOL) Score | 3-4 months post-op | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EOS + spineEOS Software in Adults Participants will receive standard of care (EOS) - 2D planning with 3D modeling.
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.
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. | 20 |
| EOS in Adults Participants will receive standard of care (EOS) - 2D planning performed with current practice.
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. | 17 |
| EOS + spineEOS Software in Children Participants will receive standard of care (EOS) - 2D planning with 3D modeling.
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.
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. | 6 |
| EOS in Children Participants will receive standard of care (EOS) - 2D planning performed with current practice.
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. | 11 |
| Total | 54 |
Baseline characteristics
| Characteristic | EOS in Adults | EOS + spineEOS Software in Children | EOS in Children | EOS + spineEOS Software in Adults | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 6 Participants | 11 Participants | 0 Participants | 17 Participants |
| Age, Categorical >=65 years | 3 Participants | 0 Participants | 0 Participants | 7 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 0 Participants | 0 Participants | 13 Participants | 27 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 19.9 | 16 years STANDARD_DEVIATION 2.8 | 16 years STANDARD_DEVIATION 2 | 44 years STANDARD_DEVIATION 18 | 38 years STANDARD_DEVIATION 21.7 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 17 participants | 6 participants | 11 participants | 20 participants | 54 participants |
| Sex: Female, Male Female | 11 Participants | 4 Participants | 8 Participants | 11 Participants | 34 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 3 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 17 | 0 / 6 | 0 / 11 |
| other Total, other adverse events | 0 / 20 | 0 / 17 | 0 / 6 | 0 / 11 |
| serious Total, serious adverse events | 0 / 20 | 0 / 17 | 0 / 6 | 0 / 11 |
Outcome results
Primary
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
Population: Only completed questionnaires for 11 subjects were analyzed: 7 out of 20 EOS + spineEOS software in adults and 4 out of 6 EOS + spineEOS software in children had completed questionnaires.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EOS + spineEOS Software in Adults | Questionnaire Showing the 3D Imaging Helped Surgery Planning | Yes | 0 Participants |
| EOS + spineEOS Software in Adults | Questionnaire Showing the 3D Imaging Helped Surgery Planning | No | 7 Participants |
| EOS + spineEOS Software in Children | Questionnaire Showing the 3D Imaging Helped Surgery Planning | Yes | 0 Participants |
| EOS + spineEOS Software in Children | Questionnaire Showing the 3D Imaging Helped Surgery Planning | No | 4 Participants |
Secondary
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
Population: Only completed questionnaires for 4 subjects were analyzed: 2 out of 20 EOS + spineEOS software in adults and 2 out of 6 EOS + spineEOS software in children had completed questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EOS + spineEOS Software in Adults | Health Related Quality Of Life (HRQOL) Score | 103 score on a scale | Standard Deviation 6 |
| EOS + spineEOS Software in Children | Health Related Quality Of Life (HRQOL) Score | 106 score on a scale | Standard Deviation 3 |