Preoperative and Peroperative Comparison Between 3D Spine Reconstructions

Safety Issues Clinical Trial

— Spine-PDCA-OR  

Official title:

Comparison of Preoperative 3D Spine Reconstruction With the EOS System and Peroperative 3D Spine Reconstruction With SURGIVISIO

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611490
• Other study ID #: 38RC20.129
• Secondary ID: 2020-A01071-38
• Status: Recruiting
• Start date: July 30, 2020
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: University Hospital, Grenoble
• Contact: Aurélien Courvoisier, MD, PhD
• Phone: 33 6 74 82 56 61
• Email: acourvoisier[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Fusion of Spine
• Navigation, Spatial
• Safety Issues
• Scoliosis
• Scoliosis Idiopathic

Intervention

Procedure:
• Spine Fusion
Each patient will undergo a spine fusion for a evolutive idiopathic scoliosis with the help of the surgivisio system.

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (9)

Courvoisier A, Garin C, Vialle R, Kohler R. The change on vertebral axial rotation after posterior instrumentation of idiopathic scoliosis. Childs Nerv Syst. 2015 Dec;31(12):2325-31. doi: 10.1007/s00381-015-2891-3. Epub 2015 Sep 4. — View Citation

Dubousset J. Scoliosis and its pathophysiology: do we understand it? Spine (Phila Pa 1976). 2001 May 1;26(9):1001. — View Citation

Ferrero E, Mazda K, Simon AL, Ilharreborde B. Preliminary experience with SpineEOS, a new software for 3D planning in AIS surgery. Eur Spine J. 2018 Sep;27(9):2165-2174. doi: 10.1007/s00586-018-5591-3. Epub 2018 Apr 24. — View Citation

Merloz P, Tonetti J, Cinquin P, Lavallée S, Troccaz J, Pittet L. [Computer-assisted surgery: automated screw placement in the vertebral pedicle]. Chirurgie. 1998 Nov;123(5):482-90. French. — View Citation

Merloz P, Tonetti J, Pittet L, Coulomb M, Lavallée S, Troccaz J, Cinquin P, Sautot P. Computer-assisted spine surgery. Comput Aided Surg. 1998;3(6):297-305. — View Citation

Merloz P, Troccaz J, Vouaillat H, Vasile C, Tonetti J, Eid A, Plaweski S. Fluoroscopy-based navigation system in spine surgery. Proc Inst Mech Eng H. 2007 Oct;221(7):813-20. — View Citation

Prod'homme M, Cavalié G, Kerschbaumer G, Valmary-Degano S, Boudissa M, Tonetti J. T1 Vertebra Pedicular Osteoid Osteoma: Minimally Invasive Surgical Resection Aided by New Integrated Navigation to 3D Imaging Device. Case Rep Orthop. 2019 Mar 18;2019:7626454. doi: 10.1155/2019/7626454. eCollection 2019. — View Citation

Stindel E, Merloz P, Graf P, Massin P, Gruber P, Robert H, Moineau G, Colmar M. [Computer assisted orthopedics surgery]. Rev Chir Orthop Reparatrice Appar Mot. 2007 Jun;93(4 Suppl):2S11-32. French. — View Citation

Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison in degrees of the pre-operative Cobb angle with the EOS system and the per-operative spine reconstruction with the Surgivisio System.	1 day
Secondary	Vertebrae automatic segmentation in 3D and 2D	The Haussdorff distance will be computed (mm)	1 year
Secondary	Automatic identification of the vertebrae	The Haussdorff distance will be computed (mm)	1 year
Secondary	Evaluation of respiratory movements on image quality	The ratio between respiratory movement and the recalage error (no unit) will be computed	1 year
Secondary	Evaluation of the "recalage" accuracy between preop planning and CBCT perop.	The root mean square error will be computed between the preop and perop 3D shape of the spine.	1 year
Secondary	Evaluation of angular measurements between preop and perop images	Comparison of angular measurements (degrees) of the spine curves between preop and perop images	1 year
Secondary	Evaluation of angular measurements between preop and postop images	Comparison of angular measurements (degrees) of the spine curves between preop and postop images	1 year
Secondary	Evaluation of angular measurements between 1st erect postop Xrays and + 6 months postop Xrays.	Comparison of angular measurements (degrees) of the spine curves between 1s erect postop and 6 months postop images	1 year
Secondary	Evaluation angular measurements between 1st erect postop Xrays and the preop planning	Comparison of angular measurements (degrees) of the spine curves between 1rst erect postop and preop images	1 year