Increased Femoral AnteversionNCT06320769
Role of Rotational Guided Growth in Management of Increased Femoral Anteversion
A study testing Plate Technique in people with Increased Femoral Anteversion, run by Ain Shams University at 1 site in Egypt.
Trial summary
Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Increased Femoral Anteversion
- What is being tested?
- Plate Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2024to 1 Mar 2026
- Phase
- Interventional
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with increased femoral anteversion causing in-toeing with decreased agility.
- Aged 8 years and above with at least two years of bone growth remaining.
Who cannot join
- Any patient who underwent previous femoral osteotomy.
- Any patient with sick physis (skeletal dysplasias, post traumatic / post infective physeal damage, active rickets).
- Cerebral Palsy (CP) patients
Trial locations and contacts
1 site in 1 country.
Tarek Hassan Abdelaziz contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ainshams University
Cairo, El-Waily
Tarek Hassan Abdelaziz, Professor, +201222421760, drtarekibrahim@gmail.com
About this study
Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.
This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.
This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs.
Read the detailed description
The purpose of this study is:
- Evaluate the efficacy of different constructs in correcting increased femoral anteversion clinically and radiographically.
- Asses possible complications of this new concept including LLD, undesired coronal, sagittal plane deformity and stiffness.
- Conditions
- Increased Femoral Anteversion
- Being tested
- Plate Technique
- Keywords
- Rotational Guided Growth, Torsional Deformities, Guided Growth, Rotational Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plate TechniqueDevice
Also called Non-absorbable Suture Technique, Cerclage Wire Technique
Using Plates, non-absorbable sutures or cerclage wires to guide the distal femoral physis towards rotational growth to correct deformity
| Study group | Role | What they receive |
|---|---|---|
| Rotational Guided Growth | Experimental | o On a radiolucent operating table with the child supine, a torniquet is applied. The limb is prepped and draped.
oA Kirschner wire is inserted in midsagittal plane of the distal femoral physis from medial to lateral under fluoroscopic guidance.
After the initial step, One of three Surgical techniques might be used according to surgeon preference and patient age:
* Plate technique
* Non-absorbable suture technique
* Cerclage wire technique Receives: Device: Plate Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait
Foot Progression Angle 5-10 degrees by clinical gait assesment
Measured: 12 months
Secondary outcomes (2)
Limb length discrepancy
Difference between length of both limbs through clinical measurement
Measured: 12 months
Angular Deformities
CR radiographic measuement including angles such as MPTA, LDFA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start20 Feb 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Femoral AnteversionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek Hassan Abdelaziz, Professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320769
- Sponsor's protocol ID
- 24101994
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Rotational Guided Growth in Management of Increased Femoral Anteversion
- ClinicalTrials.gov ID
- NCT06320769
- Acronym / sponsor ID
- 24101994
- Conditions
- Increased Femoral Anteversion
- Keywords
- Rotational Guided Growth, Torsional Deformities, Guided Growth, Rotational Deformities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 20 Mar 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.
Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.
This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.
This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs.
Detailed description
The purpose of this study is:
- Evaluate the efficacy of different constructs in correcting increased femoral anteversion clinically and radiographically.
- Asses possible complications of this new concept including LLD, undesired coronal, sagittal plane deformity and stiffness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotational Guided Growth | Experimental | Device: Plate Techniqueo On a radiolucent operating table with the child supine, a torniquet is applied. The limb is prepped and draped. oA Kirschner wire is inserted in midsagittal plane of the distal femoral physis from medial to lateral under fluoroscopic guidance. After the initial step, One of three Surgical techniques might be used according to surgeon preference and patient age: * Plate technique * Non-absorbable suture technique * Cerclage wire technique |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with increased femoral anteversion causing in-toeing with decreased agility.
- Aged 8 years and above with at least two years of bone growth remaining.
Key exclusion criteria (3 listed)
- Any patient who underwent previous femoral osteotomy.
- Any patient with sick physis (skeletal dysplasias, post traumatic / post infective physeal damage, active rickets).
- Cerebral Palsy (CP) patients
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 |
|---|---|---|
| Plate TechniqueAlso: Non-absorbable Suture Technique, Cerclage Wire TechniqueUsing Plates, non-absorbable sutures or cerclage wires to guide the distal femoral physis towards rotational growth to correct deformity | Device | Rotational Guided Growth |
Primary outcome
Gait
Time frame: 12 months
Foot Progression Angle 5-10 degrees by clinical gait assesment
2 secondary outcomes
Limb length discrepancy
Time frame: 12 months
Angular Deformities
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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.
Tarek Hassan Abdelaziz contact
Tarek Hassan Abdelaziz, Professor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plate Technique in people with Increased Femoral Anteversion, run by Ain Shams University 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 2 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: status not confirmed, as of the sponsor's last update on 20 Mar 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?
Contact Ahmed Mohamed Mohamed Abdelghany Badr, Msc (+201060085397, abaghany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait (time frame: 12 months). 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 20 Mar 2024.