Preoperative and Peroperative Comparison Between 3D Spine Reconstructions (Spine-PDCA-OR)

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

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.

Study Overview

• Status: Unknown
• Conditions: Scoliosis Idiopathic; Fusion of Spine; Safety Issues; Navigation, Spatial
• Intervention / Treatment: Procedure: Spine Fusion

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Aurélien Courvoisier, MD, PhD; Phone Number: 33 6 74 82 56 61; Email: acourvoisier@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Recruiting
    • CHU Grenoble Alpes
    • Contact: Aurélien COURVOISIER; Phone Number: +33 (0)4 76 76 65 65; Email: ACourvoisier@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will involve only patients with adolescent idiopathic scoliosis planned for a fusion surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertebrae automatic segmentation in 3D and 2D	The Haussdorff distance will be computed (mm)	1 year
Automatic identification of the vertebrae	The Haussdorff distance will be computed (mm)	1 year
Evaluation of respiratory movements on image quality	The ratio between respiratory movement and the recalage error (no unit) will be computed	1 year
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Aurélien Courvoisier, MD, PhD, University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.
• Dubousset J. Scoliosis and its pathophysiology: do we understand it? Spine (Phila Pa 1976). 2001 May 1;26(9):1001. doi: 10.1097/00007632-200105010-00002. No abstract available.
• 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.
• Merloz P, Tonetti J, Cinquin P, Lavallee S, Troccaz J, Pittet L. [Computer-assisted surgery: automated screw placement in the vertebral pedicle]. Chirurgie. 1998 Nov;123(5):482-90. doi: 10.1016/s0001-4001(99)80077-4. French.
• Merloz P, Tonetti J, Pittet L, Coulomb M, Lavallee S, Troccaz J, Cinquin P, Sautot P. Computer-assisted spine surgery. Comput Aided Surg. 1998;3(6):297-305. doi: 10.1002/(SICI)1097-0150(1998)3:63.0.CO;2-8.
• 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. doi: 10.1243/09544119JEIM268.
• Prod'homme M, Cavalie 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 38RC20.129; 2020-A01071-38 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No