Leg Length InequalityNCT04713397
Leg Length Discrepancy and Adolescent Idiopathic Scoliosis: Clinical and Radiological Characteristics
An observational study of Leg Length Inequality and Scoliosis, run by Hürriyet Yılmaz at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Leg Length Inequality, Scoliosis, Pelvic Obliquity
- What is being tested?
- Leg Length Discrepancy Scoliometer Test
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2019to 30 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Child, Adult
Study population: 10 to 18 years scoliotic patients diagnosed with structural LLD
Who may be able to join
- 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.
Who cannot join
- Neurological disease
- A history of spinal surgery/tumors
- The diagnosis of AIS without LLD or trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Formed Healthcare Scoliosis Treatment and Brace Center
Istanbul, Sisli, 34371
About this study
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.
Read the 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.
- Conditions
- Leg Length Inequality, Scoliosis, Pelvic Obliquity
- Being tested
- Leg Length Discrepancy Scoliometer Test
- Keywords
- Leg Length Discrepancy, Adolescent Idiopathic Scoliosis, Leg Length Discrepancy Scoliometer Test
- Medical subject headings
- Leg Length Inequality, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg Length Discrepancy Scoliometer TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| LLD group | Patients who have functional scoliosis due to structural LLD Receives: Diagnostic Test: Leg Length Discrepancy Scoliometer Test | |
| LLD concurrent with AIS | Patients who have structural LLD concurrent with AIS Receives: Diagnostic Test: Leg Length Discrepancy Scoliometer Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: baseline
indirect evaluation- wooden blocks
indirect evaluation method, wooden blocks of known height were used to evaluate the amount of LLD in standing position.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start6 Jan 2019
- Primary completion1 Dec 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leg Length InequalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hürriyet Yılmaz
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University, Dokuz Eylul University, Başakşehir Çam & Sakura City Hospital
- Responsible party
- Sponsor-investigator, Hürriyet Yılmaz, Halic University
- Investigators
- Ahsen Büyükaslan, PT, PhD(c), Principal investigator, Medipol UniversityKadir Abul, MD, Study chair, Başakşehir Çam & Sakura City HospitalHaluk Berk, MD, Prof., Study director, Dokuz Eylul UniversityHürriyet Yilmaz, MD, Prof., Study director, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713397
- Sponsor's protocol ID
- HUEK171-30
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 34581993
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leg Length Discrepancy and Adolescent Idiopathic Scoliosis: Clinical and Radiological Characteristics
- ClinicalTrials.gov ID
- NCT04713397
- Acronym / sponsor ID
- HUEK171-30
- Conditions
- Leg Length Inequality, Scoliosis, Pelvic Obliquity
- Keywords
- Leg Length Discrepancy, Adolescent Idiopathic Scoliosis, Leg Length Discrepancy Scoliometer Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hürriyet YılmazUniversity, hospital or other
- Collaborators
- Medipol University, Dokuz Eylul University, Başakşehir Çam & Sakura City Hospital
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLD group | – | Diagnostic Test: Leg Length Discrepancy Scoliometer TestPatients who have functional scoliosis due to structural LLD |
| LLD concurrent with AIS | – | Diagnostic Test: Leg Length Discrepancy Scoliometer TestPatients who have structural LLD concurrent with AIS |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 10 to 18 years scoliotic patients diagnosed with structural LLD
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Neurological disease
- A history of spinal surgery/tumors
- The diagnosis of AIS without LLD or trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leg Length Discrepancy Scoliometer TestA 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. | Diagnostic test | LLD concurrent with AIS, LLD group |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Derived from this study: PubMed 34581993Buyukaslan 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.
- Individual participant dataSharing planned: No
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Leg Length Inequality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahsen Büyükaslan, PT, PhD(c) principal investigator
Medipol University
Kadir Abul, MD study chair
Başakşehir Çam & Sakura City Hospital
Haluk Berk, MD, Prof. study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leg Length Inequality and Scoliosis, run by Hürriyet Yılmaz at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full spine PA radiography (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04713397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.