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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Leg Length Inequality; Pelvic Obliquity
• Intervention / Treatment: Diagnostic test: Leg Length Discrepancy Scoliometer Test

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Turkey
  • Sisli
    • Istanbul, Sisli, Turkey, 34371
      • Formed Healthcare Scoliosis Treatment and Brace Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

10 to 18 years scoliotic patients diagnosed with structural LLD

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LLD group; Patients who have functional scoliosis due to structural LLD	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.
LLD concurrent with AIS; Patients who have structural LLD concurrent with AIS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hürriyet Yılmaz
• Collaborators: Dokuz Eylul University; Medipol University; Basaksehir Cam & Sakura Şehir Hospital
• Investigators: Principal Investigator: Ahsen Büyükaslan, PT, PhD(c), Medipol University; Study Chair: Kadir Abul, MD, Basaksehir Cam & Sakura Şehir Hospital; Study Director: Haluk Berk, MD, Prof., Dokuz Eylül University; Study Director: Hürriyet Yilmaz, MD, Prof., Halic University

Publications and helpful links

General Publications

• 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. Erratum In: Spine Deform. 2021 Nov 26;:

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2019
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): January 30, 2021

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (ACTUAL): January 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Adolescent Idiopathic Scoliosis; Leg Length Discrepancy; Leg Length Discrepancy Scoliometer Test
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Spinal Curvatures; Bone Diseases, Developmental; Scoliosis; Leg Length Inequality
• Other Study ID Numbers: HUEK171-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes