Scoliosis IdiopathicSpine-PDCA-ORNCT04611490
Preoperative and Peroperative Comparison Between 3D Spine Reconstructions
An observational study of Scoliosis Idiopathic and Navigation, Spatial, run by University Hospital, Grenoble at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Scoliosis Idiopathic, Navigation, Spatial, Fusion of Spine
- What is being tested?
- Spine Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will involve only patients with adolescent idiopathic scoliosis planned for a fusion surgery
Who may be able to join
- patients aged between 12 and 20
- Adolescent idiopathic scoliosis
- Fusion surgery planned
Who cannot join
- Patient under "tutelle" or privation of liberty
- Opposition of parents or patient
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Aurélien COURVOISIER, +33 (0)4 76 76 65 65, ACourvoisier@chu-grenoble.fr
About this study
Official 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.
- Being tested
- Spine Fusion
- Medical subject headings
- Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine FusionProcedure or surgery
Each patient will undergo a spine fusion for a evolutive idiopathic scoliosis with the help of the surgivisio system.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (8)
Vertebrae automatic segmentation in 3D and 2D
The Haussdorff distance will be computed (mm)
Measured: 1 year
Automatic identification of the vertebrae
The Haussdorff distance will be computed (mm)
Measured: 1 year
Evaluation of respiratory movements on image quality
The ratio between respiratory movement and the recalage error (no unit) will be computed
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start30 Jul 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien Courvoisier, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611490
- Sponsor's protocol ID
- 38RC20.129
- Other IDs
- 2020-A01071-38
- Acronym
- Spine-PDCA-OR
- Status last verified
- Oct 2020
- First submitted
- 30 Jul 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11337615Weinstein 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.
PubMed 18456103Courvoisier 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.
PubMed 26337699Merloz 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.
PubMed 9882919Merloz 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.
PubMed 10379979Merloz 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.
PubMed 18019467Prod'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.
PubMed 31011459Ferrero 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.
PubMed 29693200Stindel 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.
PubMed 17646826
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative 3D Spine Reconstruction With the EOS System and Peroperative 3D Spine Reconstruction With SURGIVISIO
- ClinicalTrials.gov ID
- NCT04611490
- Acronym / sponsor ID
- Spine-PDCA-OR / 38RC20.129
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will involve only patients with adolescent idiopathic scoliosis planned for a fusion surgery
Key inclusion criteria (3 listed)
- patients aged between 12 and 20
- Adolescent idiopathic scoliosis
- Fusion surgery planned
Key exclusion criteria (2 listed)
- Patient under "tutelle" or privation of liberty
- Opposition of parents or patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spine FusionEach patient will undergo a spine fusion for a evolutive idiopathic scoliosis with the help of the surgivisio system. | Procedure or surgery | – |
Primary outcome
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
Time frame: 1 day
Comparison in degrees of the pre-operative Cobb angle with the EOS system and the per-operative spine reconstruction with the Surgivisio System.
8 secondary outcomes
Vertebrae automatic segmentation in 3D and 2D
Time frame: 1 year
Automatic identification of the vertebrae
Time frame: 1 year
Evaluation of respiratory movements on image quality
Time frame: 1 year
Evaluation of the "recalage" accuracy between preop planning and CBCT perop.
Time frame: 1 year
Evaluation of angular measurements between preop and perop images
Time frame: 1 year
Evaluation of angular measurements between preop and postop images
Time frame: 1 year
Evaluation of angular measurements between 1st erect postop Xrays and + 6 months postop Xrays.
Time frame: 1 year
Evaluation angular measurements between 1st erect postop Xrays and the preop planning
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Background: PubMed 11337615Dubousset 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.
- Background: PubMed 18456103Weinstein 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.
- Background: PubMed 26337699Courvoisier 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.
- Background: PubMed 9882919Merloz 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.
- Background: PubMed 10379979Merloz 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.
- Background: PubMed 18019467Merloz 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.
- Background: PubMed 31011459Prod'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.
- Background: PubMed 29693200Ferrero 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.
- Background: PubMed 17646826Stindel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien Courvoisier, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic and Navigation, Spatial, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélien Courvoisier, MD, PhD (33 6 74 82 56 61, acourvoisier@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04611490, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.