Value of 3D Modeling in Spine Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 10 - 80 |
| Updated: | 3/28/2019 |
| Start Date: | April 2016 |
| End Date: | December 2019 |
| Contact: | Lawrence R Lenke, MD |
| Email: | ll2989@columbia.edu |
| Phone: | 212-305-5974 |
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.
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.
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.
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 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 --
Inclusion Criteria:
- All patients must be younger than 18 at the time of surgery
- 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 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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Lawrence G Lenke, MD
Phone: 212-305-5974
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
