Preoperative and Peroperative Comparison Between 3D Spine Reconstructions

• Conditions: Scoliosis Idiopathic; Safety Issues; Navigation, Spatial; Fusion of Spine

• Registration Number: NCT04611490
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-30
• Study First Submitted: 2020-07-30
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-26
• Last Update Submitted: 2020-10-26
• Study First Posted: 2020-11-02
• Last Update Posted: 2020-11-02
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Vertebrae automatic segmentation in 3D and 2D	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 angular measurements between preop and perop images	1 year	Comparison of angular measurements (degrees) of the spine curves between preop and perop images
Automatic identification of the vertebrae	1 year	The Haussdorff distance will be computed (mm)
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

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 Grenoble, France