Safety Issues Clinical Trial
— Spine-PDCA-OROfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Grenoble Alpes | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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
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 |
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