Leg Length Discrepancy and Adolescent Idiopathic Scoliosis: Clinical and Radiological Characteristics

Scoliosis Clinical Trial

Official title:

Leg Length Discrepancy and Adolescent Idiopathic Scoliosis: Clinical and Radiological Characteristics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04713397
• Other study ID #: HUEK171-30
• Status: Completed
• Start date: January 6, 2019
• Est. completion date: January 30, 2021

Study information

• Verified date: January 2021
• Source: Halic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This study was conducted as a single-center retrospective comparative study on 47 consecutive scoliosis patients detected LLD, aged 10-18 years, between 2018 and 2020. The scoliosis patients with a diagnosis of structural LLD were divided into two groups according to whether there was a concurrent AIS diagnosis or not. Demographic data were recorded. Limb length was clinically measured by direct, indirect evaluation method and new LLD-Scoliometer Test. Cobb degree, axial rotation, internal/external pelvic obliquity and LLD were obtained from posteroanterior spine radiographs measured by two blinded orthopaedic spine surgeons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 30, 2021
• Est. primary completion date: December 1, 2020
• 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

Related Conditions & MeSH terms

• Leg Length Inequality
• Pelvic Obliquity
• Scoliosis

Intervention

Diagnostic Test:
• Leg Length Discrepancy Scoliometer Test
A scoliometer used as an indirect and quantitative method to evaluate LLD for the first time in this study, and described it as "Leg Length Discrepancy Scoliometer Test". Scoliometer were used on Adams' forward bending position and the level of the pelvis accepted as equal when the scoliometer degree pointed zero on the sacral basis (angle of trunk rotation on sacrum). When considering pelvis level is high on the longer side and is low on the shorter side, if the angle of the scoliometer on the sacrum is negative (slope to the left), the left extremity was considered as shorter. In order to determine its correlation with an indirect method, scoliometer degree on the sacral basis was recorded then wooden blocks were added to the unequal leg side on the sacral basis until the pelvic equality was achieved on the scoliometer. Afterward, a correlation between the first measurement of ATRsacrum and the height of the wooden block which provides ATRsacrum to reach zero was investigated.

Locations

Country	Name	City	State
Turkey	Formed Healthcare Scoliosis Treatment and Brace Center	Istanbul	Sisli

Sponsors (4)

Lead Sponsor	Collaborator
Hürriyet Yilmaz	Basaksehir Cam & Sakura Sehir Hospital, Dokuz Eylul University, Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

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