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Sponsor and PI decision
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| Name | Class |
|---|---|
| EOS imaging Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EOS + spineEOS software in adults | Experimental | Participants will receive standard of care (EOS) - 2D planning with 3D modeling. |
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| EOS in adults | Active Comparator | Participants will receive standard of care (EOS) - 2D planning performed with current practice. |
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| EOS + spineEOS software in children | Experimental | Participants will receive standard of care (EOS) - 2D planning with 3D modeling. |
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| EOS in children | Active Comparator | Participants will receive standard of care (EOS) - 2D planning performed with current practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spineEOS software | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-4 months post-op |
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Adults --
Inclusion Criteria:
Exclusion Criteria:
EOS Exclusion Criteria:
Children --
Inclusion Criteria:
Exclusion Criteria:
EOS Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence G Lenke, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10034 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 1 week post-operatively |
|
Up to 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The PI and sponsor decided to end the study early because the spineEOS software did not seem to make a difference in surgery planning.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lawrence Lenke | Columbia University Medical Center | 2129324410 | ll2989@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2017 | Dec 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| EOS | Device | The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care. |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-4 months post-op |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | 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. | 0 | 11 | 0 | 11 | 0 | 11 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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