ScoliosisNCT06369883
How Often and What Type of Deformity is Detected in All Spine Radiographs?
An observational study of Scoliosis and Kyphosis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
Trial summary
The study will be done retrospectively.The aim of this study is to retrospectively examine the spinal pathologies of patients with a prediagnosis of spinal deformity and for whom spinal radiography is requested and to evaluate the clinical features of these patients. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Scoliosis, Kyphosis, Radiography
- What is being tested?
- Spine radiography
- How many people
- 632 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Aug 2024
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 18 and under, those who were requested to have spinal radiographs for scoliosis and kyphosis
Who may be able to join
- Patients aged 18 and under
- Those who requested spine radiographs for scoliosis and kyphosis
Who cannot join
- Having a history of previous spinal surgery or trauma
- Repeated radiographs in the same patient
About this study
Official title: Medical Doctor, Physiatrist
The study will be done retrospectively.The aim of this study is to retrospectively examine the spinal pathologies of patients with a prediagnosis of spinal deformity and for whom spinal radiography is requested and to evaluate the clinical features of these patients.
Read the detailed description
Spinal radiography for scoliosis is the gold standard in the diagnosis, treatment and follow-up of spinal diseases. There are studies showing that unnecessary and repetitive radiographs of patients increase the risk of cancer in older ages. Patients should be thoroughly examined before a spine radiograph is taken. Adam's test should be applied to the patient with scoliosis findings in the physical examination. Spinal radiography for Scoliosis should be requested from those whose trunk rotation angle is 5 degrees or more during Adam's test. The diagnosis of scoliosis is made when the Cobb angle measured on posterior-anterior radiographs is greater than 10 degrees. The diagnosis of kyphosis is made when the Cobb angle measured on lateral radiographs is greater than 50 degrees. Patients with a prediagnosis of spinal deformity and spinal radiographs taken between January 2019 and September 2019 in the Radiology clinic of our hospital will be included in the study. Demographic characteristics of the patients, presence and degree of scoliosis on posterior-anterior radiographs, if present, degree of kyphosis on lateral radiographs, structural pathologies in the spine and clinical features will be investigated.
- Conditions
- Scoliosis, Kyphosis, Radiography
- Being tested
- Spine radiography
- Keywords
- scoliosis,kyphosis,radiography
- Medical subject headings
- Scoliosis, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine radiographyDiagnostic test
Posterior-anterior and lateral spine radiography
| Study group | Role | What they receive |
|---|---|---|
| Subjects under 18 years of age who underwent spinal radiography | Angle measurement with Cobb method in posterior-anterior and lateral radiographs of patients who underwent spinal radiographs Receives: Diagnostic Test: Spine radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Who should have full spine radiographs?
The aim of the study is to determine the percentage of unnecessary X-rays required for he definitive diagnosis of spinal deformities and to emphasize the importance of clinical examination in requesting X-rays.
Measured: 3 month
Secondary outcomes (1)
We aimed to determine the frequency of kyphosis, types and percentages of scoliosis detected on the radiographs.
A curvature of the spine of 10° or more detected radiologically in the coronal plane is defined as scoliosis, and a curvature of over 50 degrees in the sagittal plane is defined as kyphosis. The Cobb method is calculated by measuring the angle between the parallel line drawn from the top of the top vertebra where the curvature is greatest and from the bottom of the bottom vertebra. Scoliosis is classified according to the location of the apical vertebra.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Filiz Yildiz Aydin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369883
- Sponsor's protocol ID
- 2022/41
- Status last verified
- Apr 2024
- First submitted
- 23 Aug 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Doctor, Physiatrist
- ClinicalTrials.gov ID
- NCT06369883
- Acronym / sponsor ID
- 2022/41
- Conditions
- Scoliosis, Kyphosis, Radiography
- Keywords
- scoliosis,kyphosis,radiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 17 Apr 2024 (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 study will be done retrospectively.The aim of this study is to retrospectively examine the spinal pathologies of patients with a prediagnosis of spinal deformity and for whom spinal radiography is requested and to evaluate the clinical features of these patients.
Detailed description
Spinal radiography for scoliosis is the gold standard in the diagnosis, treatment and follow-up of spinal diseases. There are studies showing that unnecessary and repetitive radiographs of patients increase the risk of cancer in older ages. Patients should be thoroughly examined before a spine radiograph is taken. Adam's test should be applied to the patient with scoliosis findings in the physical examination. Spinal radiography for Scoliosis should be requested from those whose trunk rotation angle is 5 degrees or more during Adam's test. The diagnosis of scoliosis is made when the Cobb angle measured on posterior-anterior radiographs is greater than 10 degrees. The diagnosis of kyphosis is made when the Cobb angle measured on lateral radiographs is greater than 50 degrees. Patients with a prediagnosis of spinal deformity and spinal radiographs taken between January 2019 and September 2019 in the Radiology clinic of our hospital will be included in the study. Demographic characteristics of the patients, presence and degree of scoliosis on posterior-anterior radiographs, if present, degree of kyphosis on lateral radiographs, structural pathologies in the spine and clinical features will be investigated.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects under 18 years of age who underwent spinal radiography | – | Diagnostic Test: Spine radiographyAngle measurement with Cobb method in posterior-anterior and lateral radiographs of patients who underwent spinal radiographs |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 18 and under, those who were requested to have spinal radiographs for scoliosis and kyphosis
Key inclusion criteria (2 listed)
- Patients aged 18 and under
- Those who requested spine radiographs for scoliosis and kyphosis
Key exclusion criteria (2 listed)
- Having a history of previous spinal surgery or trauma
- Repeated radiographs in the same 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 radiographyPosterior-anterior and lateral spine radiography | Diagnostic test | Subjects under 18 years of age who underwent spinal radiography |
Primary outcome
Who should have full spine radiographs?
Time frame: 3 month
The aim of the study is to determine the percentage of unnecessary X-rays required for he definitive diagnosis of spinal deformities and to emphasize the importance of clinical examination in requesting X-rays.
1 secondary outcome
We aimed to determine the frequency of kyphosis, types and percentages of scoliosis detected on the radiographs.
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Kyphosis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
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 2 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Who should have full spine radiographs? (time frame: 3 month). 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 17 Apr 2024.