Scoliosis IdiopathicNCT05033171
Rod Shape Changing After Scoliosis Correction Surgery
A study testing 3D Scanning and EOS 2D/3D scanning in people with Scoliosis Idiopathic and Scoliosis, Severe, run by University of Pecs at 1 site in Hungary.
Trial summary
The change of the fixation-rod after posterior srew-rod fixation segmentdesis is not widely known. The recent development of the 3D scanning technics and the opportunities of the EOS 2D/3D system made us possible to have the exact rod shape immediately after implantation, and at each control examination. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis, Severe
- What is being tested?
- 3D Scanning and EOS 2D/3D scanning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2019to 31 Dec 2022
- Phase
- Interventional
- 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- routine patient care of University of Pécs Medical School Department of Orthopaedics
- diagnosed idiopathic adolescent scoliosis
- scoliosis induced surgical indication (Cobb-degree>45)
Who cannot join
- early onset or adult degenerative scoliosis
- scoliosis with known origin
- the angle of the curve does not reach the criteria of surgical indication (Cobb-degree<45)
- former spine surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Changing of the Fixation-rod Shape After Posterior Correction Segmentdesis in Adolescent Idiopathic Scoliosis
The change of the fixation-rod after posterior srew-rod fixation segmentdesis is not widely known. The recent development of the 3D scanning technics and the opportunities of the EOS 2D/3D system made us possible to have the exact rod shape immediately after implantation, and at each control examination. These progressions made us available to follow up the shape changing of the fixation-rod, hereby the changing of the correction.
Read the detailed description
The adolescent idiopathic scoliosis can affect the 0,5-2% of the European population. One of the widely accepted treatment of severe scoliosis (Cobb angle is over 40-50°, or more than 10° progression observed a year) is posterior correction segmentdesis with screw and rod instrumentation. As a scoliosis treatment center, about 90-110 scoliosis correction surgeries are performed in our department, using conventional preoperative planning, coronal and sagittal translation technique from posterolateral approach.
An EOS 2D/3D system is available in our department making possible the scanning of the patient with upright biplanar ultra-low dose x-rays technique. The SterEOS software makes us possible to reconstruct the surface of the spine, pelvis and lower limb. The biplanar modality of the images makes possible to 3D reconstruct any simple shape using CAD (computer-aided design) softwares.
The recent updates in the 3D scanning technology also made us possible to perform intraoperative scannings without harming the sterility.
The aim of the study to define the change of the fixation-rod's shape after scoliosis correction surgery.
Main hypothesis: there is significant change in the rod shape after implantation
Secondary hypothesis 1: during the implant of the rod, it will loose from the prebent correction depending of the severity and rigidity of the curve.
Secondary hypothesis 2: in the early stage of the rehabilitation, after the mobilization the shape of the rod (and the spinal parameters) can change Secondary hypothesis 3: after the 3. month postoperatively the shape of rod does not change anymore
- Conditions
- Scoliosis Idiopathic, Scoliosis, Severe
- Being tested
- 3D Scanning, EOS 2D/3D scanning
- Keywords
- scoliosis, posterior segmentdesis, 3D scanning, EOS 2D/3D
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D ScanningDiagnostic test
3D scanning of the rod using Artec Eva Spider type manual 3D scanner
EOS 2D/3D scanningDiagnostic test
EOS Micro Dose imaging will be done on the third day after surgery, on the third, the sixth, the twelfth and twenty fourth month after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients with scoliosis induced surgical indication (Cobb-degree>45).
* Posterior screw-rod fixation segmentdesis
* Before the implantation, right after the implantation and after the in situ bending 3D scanning of the rod using Artec Eva Spider type manual 3D scanner will be performed. Scanning is possible from a more than 60 cm distance, so that means the operational area stays sterile.
* EOS Micro Dose imaging will be done on the third day after surgery, on the third, the sixth, the twelfth and twenty fourth month after surgery (as in the actual clinical protocal). Receives: Diagnostic Test: 3D Scanning; Diagnostic Test: EOS 2D/3D scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shape changing of the rod
The fitted 3D models of the implanted rod right after implantation, 3 day, than 3-6-12-24 months after the surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Sep 2019
- Primary completion30 Sep 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Than, PhD, Study chair, UP MS Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033171
- Sponsor's protocol ID
- UP-CC-Ortho-RodShape
- Status last verified
- Mar 2023
- First submitted
- 29 Aug 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changing of the Fixation-rod Shape After Posterior Correction Segmentdesis in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05033171
- Acronym / sponsor ID
- UP-CC-Ortho-RodShape
- Conditions
- Scoliosis Idiopathic, Scoliosis, Severe
- Keywords
- scoliosis, posterior segmentdesis, 3D scanning, EOS 2D/3D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Sep 2021 (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 change of the fixation-rod after posterior srew-rod fixation segmentdesis is not widely known. The recent development of the 3D scanning technics and the opportunities of the EOS 2D/3D system made us possible to have the exact rod shape immediately after implantation, and at each control examination. These progressions made us available to follow up the shape changing of the fixation-rod, hereby the changing of the correction.
Detailed description
The adolescent idiopathic scoliosis can affect the 0,5-2% of the European population. One of the widely accepted treatment of severe scoliosis (Cobb angle is over 40-50°, or more than 10° progression observed a year) is posterior correction segmentdesis with screw and rod instrumentation. As a scoliosis treatment center, about 90-110 scoliosis correction surgeries are performed in our department, using conventional preoperative planning, coronal and sagittal translation technique from posterolateral approach.
An EOS 2D/3D system is available in our department making possible the scanning of the patient with upright biplanar ultra-low dose x-rays technique. The SterEOS software makes us possible to reconstruct the surface of the spine, pelvis and lower limb. The biplanar modality of the images makes possible to 3D reconstruct any simple shape using CAD (computer-aided design) softwares.
The recent updates in the 3D scanning technology also made us possible to perform intraoperative scannings without harming the sterility.
The aim of the study to define the change of the fixation-rod's shape after scoliosis correction surgery.
Main hypothesis: there is significant change in the rod shape after implantation
Secondary hypothesis 1: during the implant of the rod, it will loose from the prebent correction depending of the severity and rigidity of the curve.
Secondary hypothesis 2: in the early stage of the rehabilitation, after the mobilization the shape of the rod (and the spinal parameters) can change Secondary hypothesis 3: after the 3. month postoperatively the shape of rod does not change anymore
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: 3D Scanning, Diagnostic Test: EOS 2D/3D scanningPatients with scoliosis induced surgical indication (Cobb-degree>45). * Posterior screw-rod fixation segmentdesis * Before the implantation, right after the implantation and after the in situ bending 3D scanning of the rod using Artec Eva Spider type manual 3D scanner will be performed. Scanning is possible from a more than 60 cm distance, so that means the operational area stays sterile. * EOS Micro Dose imaging will be done on the third day after surgery, on the third, the sixth, the twelfth and twenty fourth month after surgery (as in the actual clinical protocal). |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- routine patient care of University of Pécs Medical School Department of Orthopaedics
- diagnosed idiopathic adolescent scoliosis
- scoliosis induced surgical indication (Cobb-degree>45)
Key exclusion criteria (4 listed)
- early onset or adult degenerative scoliosis
- scoliosis with known origin
- the angle of the curve does not reach the criteria of surgical indication (Cobb-degree<45)
- former spine surgery
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 |
|---|---|---|
| 3D Scanning3D scanning of the rod using Artec Eva Spider type manual 3D scanner | Diagnostic test | Study group |
| EOS 2D/3D scanningEOS Micro Dose imaging will be done on the third day after surgery, on the third, the sixth, the twelfth and twenty fourth month after surgery. | Diagnostic test | Study group |
Primary outcome
Shape changing of the rod
Time frame: 2 years
The fitted 3D models of the implanted rod right after implantation, 3 day, than 3-6-12-24 months after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- 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.
Peter Than, PhD study chair
UP MS Department of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Scanning and EOS 2D/3D scanning in people with Scoliosis Idiopathic and Scoliosis, Severe, run by University of Pecs at 1 site in Hungary.
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 4 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: finished, as of the sponsor's last update on 23 Mar 2023. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shape changing of the rod (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.