Preoperative and Peroperative Comparison Between 3D Spine Reconstructions

NCT04611490 | Unknown

• 2 other identifiers: 38RC20.1292020-A01071-38
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Vertebrae automatic segmentation in 3D and 2D

  1 year

• Automatic identification of the vertebrae

  1 year

• Evaluation of respiratory movements on image quality

  1 year

• Evaluation of the "recalage" accuracy between preop planning and CBCT perop.

  1 year

• Evaluation of angular measurements between preop and perop images

  1 year

Interventions

Spine Fusion PROCEDURE

Each patient will undergo a spine fusion for a evolutive idiopathic scoliosis with the help of the surgivisio system.

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• patients aged between 12 and 20
• Adolescent idiopathic scoliosis
• Fusion surgery planned

You may not qualify if:

• Patient under "tutelle" or privation of liberty
• Opposition of parents or patient

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

RECRUITING

Related Publications (9)

• 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.

  PMID: 11337615 BACKGROUND

• 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.

  PMID: 18456103 BACKGROUND

• 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.

  PMID: 26337699 BACKGROUND

• 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.

  PMID: 9882919 BACKGROUND

• 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.

  PMID: 10379979 BACKGROUND

• 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.

  PMID: 18019467 BACKGROUND

• 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.

  PMID: 31011459 BACKGROUND

• 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.

  PMID: 29693200 BACKGROUND

• 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.

  PMID: 17646826 BACKGROUND

MeSH Terms

Conditions

Spatial Navigation

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Aurélien Courvoisier, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélien Courvoisier, MD, PhD

CONTACT

33 6 74 82 56 61; acourvoisier@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: November 2, 2020
• Study Start: July 30, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)