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

NCT04713397 | Completed FDA Device

• 1 other identifier: HUEK171-30
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leg Length Inequality; Scoliosis; Pelvic Obliquity

Keywords

Leg Length Discrepancy; Adolescent Idiopathic Scoliosis; Leg Length Discrepancy Scoliometer Test

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• indirect evaluation- wooden blocks

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

  baseline

Study Arms (2)

LLD group

Patients who have functional scoliosis due to structural LLD

Diagnostic Test: Leg Length Discrepancy Scoliometer Test

LLD concurrent with AIS

Patients who have structural LLD concurrent with AIS

Diagnostic Test: Leg Length Discrepancy Scoliometer Test

Interventions

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.

LLD concurrent with AIS; LLD group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

10 to 18 years scoliotic patients diagnosed with structural LLD

You may qualify if:

• 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.

You may not qualify if:

• Neurological disease
• A history of spinal surgery/tumors
• The diagnosis of AIS without LLD or trauma

Sponsors & Collaborators

• Hürriyet Yılmaz: lead
• Medipol University: collaborator
• Dokuz Eylul University: collaborator
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (1)

Formed Healthcare Scoliosis Treatment and Brace Center

Istanbul, Sisli, 34371, Turkey (Türkiye)

Location

Related Publications (1)

• Buyukaslan A, Abul K, Berk H, Yilmaz H. Leg length discrepancy and adolescent idiopathic scoliosis: clinical and radiological characteristics. Spine Deform. 2022 Mar;10(2):307-314. doi: 10.1007/s43390-021-00417-0. Epub 2021 Sep 28.

  PMID: 34581993 DERIVED

MeSH Terms

Conditions

Leg Length Inequality; Scoliosis

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases

Study Officials

• Ahsen Büyükaslan, PT, PhD(c)

  Medipol University

  PRINCIPAL INVESTIGATOR

• Kadir Abul, MD

  Başakşehir Çam & Sakura City Hospital

  STUDY CHAIR

• Haluk Berk, MD, Prof.

  Dokuz Eylul University

  STUDY DIRECTOR

• Hürriyet Yilmaz, MD, Prof.

  Halic University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD.Prof.

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: January 6, 2019
• Primary Completion: December 1, 2020
• Study Completion: January 30, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)