ScoliosisNCT06276972
Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical in Scoliosis
An observational study of Scoliosis, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis
- How many people
- 89 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2023to 15 Mar 2024
- 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: adolescents with idiopathic scoliotic curvature of structural origin and in which any secondary causes could be excluded
Who may be able to join
- Adolescents with age 10-18 years
- complaining of dorsolumbar scoliosis
- curves (apex lies between D10 and L4)
- curve magnitudes greater than 15 degrees and less than 90
- using or not using brace
- all maturity levels (Risser = 0-5)
Who cannot join
- Other types of scoliosis ; congenital or neuromuscular
- Current physical therapy or medical treatment for scoliosis,
- Contracture or surgery affecting the lumbar spine or lower limbs
- Pathologies such as inflammatory diseases
- congenital anomalies
- Neurological disorders like cerebral palsy or ataxia
- dislocations
- visual or auditory problems
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Delta university for science and technology
Gamasa, Dakahlia Governorate, 7731168
About this study
Official title: The Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical Parameters in Scoliotic Adolescents. A Cross Sectional Study
To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents
Read the detailed description
BACKGROUND:
Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. Numerous studies deal with the aetiology of the disease, X-ray morphology and classification of curvatures and how the disorder disrupts the spinal biomechanical balance, however the disorder is a complex three-dimensional deformity that affects the body as a whole, and these effects must not be overlooked. No cross-section studies were found assessing the connection between sagittal or coronal balance and the biomechanical parameters of the lower extremity.
HYPOTHESES:
Null hypothesis There are no statistically significant relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents.
RESEARCH QUESTION:
What are the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents?
PURPOSE: To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents
- Conditions
- Scoliosis
- Being tested
- no intervention
- Keywords
- scoliosis, spine alignment, lower limb, biomechanics
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
there's no intervention. it's a cross sectional study correlation study
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis | scoliotic adolescents ranged in age from 10- 18 years will be enrolled Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb's angle
Cobb's angle for dorso-lumbar scoliosis. The angle of the curve apex from D10 to L4 will be assessed by computed radiograph (X-ray computed scanogram)
Measured: at the enrollment
Coronal balance
Coronal balance estimated by the distance between plumb line and central sacral line from Anetroposterior x-ray view assessed by computed radiograph (X-ray computed scanogram )
Measured: at the enrollment
length of the the tibia and femur
The length (in centimeter) of the Tibia and femur will be assessed by computed radiograph (X-ray computed scan-gram)
Measured: at the enrollment
tibiofemoral angle
The tibiofemoral angle (TFA), or knee angle, is defined as the angle between the anatomical axis of femur with the anatomical axis of tibia. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)
Measured: at the enrollment
knee joint line convergence angle
The knee joint-line convergence angle (KJLCA) h is the angle made by a tangential line between the femoral condyles and the tibial plateau. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)
Measured: at the enrollment
lower limb mechanical axis; and mechanical axis deviation
The mechanical axis of the lower limb, also called the Mikulicz line, is drawn by connecting a point in the center of the femoral head to a point in the center of the ankle. The value of the deviation is measured in millimeters and is named mechanical axis deviation (MAD). It will be assessed by computed radiograph (X-ray computed scan-gram).
Measured: at the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start12 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Omar Mohamed Ali Elabd, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276972
- Sponsor's protocol ID
- P.T.REC/012/005000
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: personal preference
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical Parameters in Scoliotic Adolescents. A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06276972
- Acronym / sponsor ID
- P.T.REC/012/005000
- Conditions
- Scoliosis
- Keywords
- scoliosis, spine alignment, lower limb, biomechanics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 26 Feb 2024 (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.
To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents
Detailed description
BACKGROUND:
Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. Numerous studies deal with the aetiology of the disease, X-ray morphology and classification of curvatures and how the disorder disrupts the spinal biomechanical balance, however the disorder is a complex three-dimensional deformity that affects the body as a whole, and these effects must not be overlooked. No cross-section studies were found assessing the connection between sagittal or coronal balance and the biomechanical parameters of the lower extremity.
HYPOTHESES:
Null hypothesis There are no statistically significant relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents.
RESEARCH QUESTION:
What are the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents?
PURPOSE: To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scoliosis | – | Other: no interventionscoliotic adolescents ranged in age from 10- 18 years will be enrolled |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- adolescents with idiopathic scoliotic curvature of structural origin and in which any secondary causes could be excluded
Key inclusion criteria (6 listed)
- Adolescents with age 10-18 years
- complaining of dorsolumbar scoliosis
- curves (apex lies between D10 and L4)
- curve magnitudes greater than 15 degrees and less than 90
- using or not using brace
Key exclusion criteria (8 listed)
- Other types of scoliosis ; congenital or neuromuscular
- Current physical therapy or medical treatment for scoliosis,
- Contracture or surgery affecting the lumbar spine or lower limbs
- Pathologies such as inflammatory diseases
- congenital anomalies
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 |
|---|---|---|
| no interventionthere's no intervention. it's a cross sectional study correlation study | Other | Scoliosis |
Primary outcome
Cobb's angle
Time frame: at the enrollment
Cobb's angle for dorso-lumbar scoliosis. The angle of the curve apex from D10 to L4 will be assessed by computed radiograph (X-ray computed scanogram)
Coronal balance
Time frame: at the enrollment
Coronal balance estimated by the distance between plumb line and central sacral line from Anetroposterior x-ray view assessed by computed radiograph (X-ray computed scanogram )
length of the the tibia and femur
Time frame: at the enrollment
The length (in centimeter) of the Tibia and femur will be assessed by computed radiograph (X-ray computed scan-gram)
tibiofemoral angle
Time frame: at the enrollment
The tibiofemoral angle (TFA), or knee angle, is defined as the angle between the anatomical axis of femur with the anatomical axis of tibia. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)
knee joint line convergence angle
Time frame: at the enrollment
The knee joint-line convergence angle (KJLCA) h is the angle made by a tangential line between the femoral condyles and the tibial plateau. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)
lower limb mechanical axis; and mechanical axis deviation
Time frame: at the enrollment
The mechanical axis of the lower limb, also called the Mikulicz line, is drawn by connecting a point in the center of the femoral head to a point in the center of the ankle. The value of the deviation is measured in millimeters and is named mechanical axis deviation (MAD). It will be assessed by computed radiograph (X-ray computed scan-gram).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No. personal preference
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Scoliosis, run by Delta University for Science and Technology at 1 site in Egypt.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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 Egypt. 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?
Results are not available in the source record.
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?
Cobb's angle (time frame: at the enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024.