Scoliosis Clinical Trial
Official title:
Leg Length Discrepancy and Adolescent Idiopathic Scoliosis: Clinical and Radiological Characteristics
NCT number | NCT04713397 |
Other study ID # | HUEK171-30 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 6, 2019 |
Est. completion date | January 30, 2021 |
Verified date | January 2021 |
Source | Halic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this retrospective study is to present clinical and radiological features and their relationships for differentiating functional scoliosis due to LLD and LLD concurrent with AIS.
Status | Completed |
Enrollment | 47 |
Est. completion date | January 30, 2021 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | Inclusion Criteria: - Between December 2018-2020 - Scoliotic patients, who detected LLD - Ages 10 to 18 years - Patients who have two or more clinical records at least 6 months apart - Who accepted to participate in the study. Exclusion Criteria: - Neurological disease - A history of spinal surgery/tumors - The diagnosis of AIS without LLD or trauma |
Country | Name | City | State |
---|---|---|---|
Turkey | Formed Healthcare Scoliosis Treatment and Brace Center | Istanbul | Sisli |
Lead Sponsor | Collaborator |
---|---|
Hürriyet Yilmaz | Basaksehir Cam & Sakura Sehir Hospital, Dokuz Eylul University, Medipol University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Full spine PA radiography | Posteroanterior whole spine digital X-Ray images were obtained with the patient barefoot, both heels on the floor, and both knees extended in an upright standing position. The digital radiography detector was 350x430 millimeters in size and clearly showed the positions of the femoral heads, the iliac crests, and whole spine. The distance between the X-ray tube and the detector was two meters. All radiographic data such as Cobb degree, axial rotation by Perdriolle and pelvic obliquity were measured by two blinded orthopaedic spine surgeons using Surgimap ® Spine (Nemaris ™ Inc, New York, NY) a validated software | baseline | |
Primary | direct evaluation- tape measure | Limb length was clinically with a tape measure while the patient was in a supine position. For the direct evaluation method, measurements were taken from the anterior superior iliac spine to the medial malleolus. | baseline | |
Primary | indirect evaluation- wooden blocks | indirect evaluation method, wooden blocks of known height were used to evaluate the amount of LLD in standing position. | baseline |
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