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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06369883
Other study ID # 2022/41
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date August 30, 2024

Study information

Verified date April 2024
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 632
Est. completion date August 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria: 1. Patients aged 18 and under 2. Those who requested spine radiographs for scoliosis and kyphosis Exclusion Criteria: 1. Having a history of previous spinal surgery or trauma 2. Repeated radiographs in the same patient

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Spine radiography
Posterior-anterior and lateral spine radiography

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 month
Secondary 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. 3 month
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