- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06369883
How Often and What Type of Deformity is Detected in All Spine Radiographs?
April 12, 2024 updated by: Filiz Yildiz Aydin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
632
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients aged 18 and under, those who were requested to have spinal radiographs for scoliosis and kyphosis
Description
Inclusion Criteria:
- Patients aged 18 and under
- Those who requested spine radiographs for scoliosis and kyphosis
Exclusion Criteria:
- Having a history of previous spinal surgery or trauma
- Repeated radiographs in the same patient
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Posterior-anterior and lateral spine radiography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
We aimed to determine the frequency of kyphosis, types and percentages of scoliosis detected on the radiographs.
Time Frame: 3 month
|
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.
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
August 23, 2022
First Submitted That Met QC Criteria
April 12, 2024
First Posted (Actual)
April 17, 2024
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 12, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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