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Completed

NCT Number: NCT04713397

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

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.

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Key information

Conditions

Leg Length Inequality Bone Diseases Bone Diseases, Developmental Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Obliquity Scoliosis Spinal Curvatures Spinal Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Formed Healthcare Scoliosis Treatment and Brace Center

Istanbul, Sisli, 34371, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leg Length Discrepancy Scoliometer Test

Diagnostic 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.

Primary outcomes

  1. Full spine PA radiography

    Time frame: baseline

    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

  2. direct evaluation- tape measure

    Time frame: baseline

    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.

  3. indirect evaluation- wooden blocks

    Time frame: baseline

    indirect evaluation method, wooden blocks of known height were used to evaluate the amount of LLD in standing position.

Sponsors and collaborators

Lead sponsor

Hürriyet Yılmaz

Other

Collaborators

  • Başakşehir Çam & Sakura City Hospital
  • Dokuz Eylul University
  • Medipol University

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 19, 2021
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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