Trial Outcomes & Findings for Value of 3D Modeling in Spine Surgery (NCT NCT02771899)
NCT ID: NCT02771899
Last Updated: 2024-07-31
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
1 week post-operatively
Results posted on
2024-07-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
6
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
17
|
6
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EOS + spineEOS Software in Adults
n=20 Participants
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.
|
EOS in Adults
n=17 Participants
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.
|
EOS + spineEOS Software in Children
n=6 Participants
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.
|
EOS in Children
n=11 Participants
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.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=17 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=11 Participants
|
17 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=20 Participants
|
14 Participants
n=17 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
27 Participants
n=54 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=20 Participants
|
3 Participants
n=17 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
10 Participants
n=54 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 18 • n=20 Participants
|
52 years
STANDARD_DEVIATION 19.9 • n=17 Participants
|
16 years
STANDARD_DEVIATION 2.8 • n=6 Participants
|
16 years
STANDARD_DEVIATION 2 • n=11 Participants
|
38 years
STANDARD_DEVIATION 21.7 • n=54 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=20 Participants
|
11 Participants
n=17 Participants
|
4 Participants
n=6 Participants
|
8 Participants
n=11 Participants
|
34 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
6 Participants
n=17 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
20 Participants
n=54 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
17 participants
n=17 Participants
|
6 participants
n=6 Participants
|
11 participants
n=11 Participants
|
54 participants
n=54 Participants
|
PRIMARY outcome
Timeframe: 1 week post-operativelyPopulation: 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.
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.
Outcome measures
| Measure |
EOS + spineEOS Software in Adults
n=7 Participants
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.
|
EOS + spineEOS Software in Children
n=4 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Questionnaire Showing the 3D Imaging Helped Surgery Planning
Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Questionnaire Showing the 3D Imaging Helped Surgery Planning
No
|
7 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3-4 months post-opPopulation: 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.
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.
Outcome measures
| Measure |
EOS + spineEOS Software in Adults
n=2 Participants
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.
|
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.
|
EOS + spineEOS Software in Children
n=2 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Health Related Quality Of Life (HRQOL) Score
|
103 score on a scale
Standard Deviation 6
|
—
|
106 score on a scale
Standard Deviation 3
|
—
|
Adverse Events
EOS + spineEOS Software in Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EOS in Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EOS + spineEOS Software in Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EOS in Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place