- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04713397
Leg Length Discrepancy and Adolescent Idiopathic Scoliosis: Clinical and Radiological Characteristics
May 21, 2021 updated by: Hürriyet Yılmaz
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sisli
-
Istanbul, Sisli, Turkey, 34371
- Formed Healthcare Scoliosis Treatment and Brace Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
LLD group
Patients who have functional scoliosis due to structural LLD
|
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
|
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
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
|
baseline
|
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.
|
baseline
|
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.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Eylul University
- Study Director: Hürriyet Yilmaz, MD, Prof., Haliç University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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