Fusion of Spine, Navigation, Spatial, Safety Issues, Scoliosis Idiopathic
Conditions
Brief summary
The objective is to collect data from a per-operative navigation system called SURGIVISIO during scoliosis surgeries. A research program is in progress in order super-impose pre-operative 3D reconstructions of the spine performed with the EOS system on the per-operative 3D reconstructions performed with the SURGIVISIO system. The purpose of the study is to collect the pre and per operatives data in order to perform the research and development program.
Interventions
PROCEDURESpine Fusion
Each patient will undergo a spine fusion for a evolutive idiopathic scoliosis with the help of the surgivisio system.
Sponsors
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* patients aged between 12 and 20 * Adolescent idiopathic scoliosis * Fusion surgery planned
Exclusion criteria
* Patient under tutelle or privation of liberty * Opposition of parents or patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison between the shape of of the spine in supine position in the OR with the Surgivisio system and the 3D shape with the 3D pre-operative planning with the EOS | 1 day | Comparison in degrees of the pre-operative Cobb angle with the EOS system and the per-operative spine reconstruction with the Surgivisio System. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vertebrae automatic segmentation in 3D and 2D | 1 year | The Haussdorff distance will be computed (mm) |
| Automatic identification of the vertebrae | 1 year | The Haussdorff distance will be computed (mm) |
| Evaluation of the recalage accuracy between preop planning and CBCT perop. | 1 year | The root mean square error will be computed between the preop and perop 3D shape of the spine. |
| Evaluation of respiratory movements on image quality | 1 year | The ratio between respiratory movement and the recalage error (no unit) will be computed |
| Evaluation of angular measurements between preop and postop images | 1 year | Comparison of angular measurements (degrees) of the spine curves between preop and postop images |
| Evaluation of angular measurements between 1st erect postop Xrays and + 6 months postop Xrays. | 1 year | Comparison of angular measurements (degrees) of the spine curves between 1s erect postop and 6 months postop images |
| Evaluation angular measurements between 1st erect postop Xrays and the preop planning | 1 year | Comparison of angular measurements (degrees) of the spine curves between 1rst erect postop and preop images |
| Evaluation of angular measurements between preop and perop images | 1 year | Comparison of angular measurements (degrees) of the spine curves between preop and perop images |
Countries
France
Contacts
Primary ContactAurélien Courvoisier, MD, PhD
Outcome results
None listed