Clinical trial NCT04611490: Preoperative and Peroperative Comparison Between 3D Spine Reconstructions
Official title: Comparison of Preoperative 3D Spine Reconstruction With the EOS System and Peroperative 3D Spine Reconstruction With SURGIVISIO
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis Idiopathic
Navigation, Spatial
Fusion of Spine
Safety Issues
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will involve only patients with adolescent idiopathic scoliosis planned for a fusion surgery

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 day
Secondary outcomes:
measure: Vertebrae automatic segmentation in 3D and 2D
timeFrame: 1 year
measure: Automatic identification of the vertebrae
timeFrame: 1 year
measure: Evaluation of respiratory movements on image quality
timeFrame: 1 year
measure: Evaluation of the "recalage" accuracy between preop planning and CBCT perop.
timeFrame: 1 year
measure: Evaluation of angular measurements between preop and perop images
timeFrame: 1 year
measure: Evaluation of angular measurements between preop and postop images
timeFrame: 1 year
measure: Evaluation of angular measurements between 1st erect postop Xrays and + 6 months postop Xrays.
timeFrame: 1 year
measure: Evaluation angular measurements between 1st erect postop Xrays and the preop planning
timeFrame: 1 year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Aurélien Courvoisier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
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citation: 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.
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.
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.