Paediatric SurgeryNCT05334862
Residual Torsional Deformity in Pediatric Genu Varum After Coronal Plane Deformity Correction by 8 Plate Hemi Epiphysiodesis.
A study testing 8 plate hemiepiphysiodesis in people with Paediatric Surgery, run by Assiut University at 1 site in Egypt.
Trial summary
This study is to evaluate the residual torsional deformity in pediatric Genu Varum after coronal plane deformity correction by 8 plate hemi epiphysiodesis. Read more about this study
- Who is it for?
- Ages 30 months to 12 years
- Conditions the study is for
- Paediatric Surgery
- What is being tested?
- 8 plate hemiepiphysiodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2025to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 months to 12 years
- All sexes
- No healthy volunteers
- Child
- Inclusion criteria: skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral)
- Exclusion criteria:
- skeletal maturity.
- epiphyseal dysplasia.
- metabolic and neurologic disorders.
- previous trauma.
- patients younger than 2.5 years and older than 12 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, Asyut Governorate, 71511
Mohammed Elsharkawy, head of orthopaedic department, +201005075855, sharkoran@aun.edu.eg
Hesham Elbaseet, professor
About this study
This study is to evaluate the residual torsional deformity in pediatric Genu Varum after coronal plane deformity correction by 8 plate hemi epiphysiodesis.
Read the detailed description
Angular deformities around the knee in children is a common finding including genu valgum and genu varum.
The genu valgum or varum may be idiopathic or arise from diverse etiologies, such as trauma, dysplasia, metabolic disease, inflammatory, endocrine, tumor, neoplastic, or developmental pathologies.
Surgical treatment options include osteotomies with either acute or gradual correction and temporary hemi epiphysiodesis (guided growth),the latter being less invasive and with significantly lower rate of major complications.
Guided growth by 8 plate hemi epiphysiodesis is commonly used to correct coronal plane deformity around the knee. Since its introduction by Stevens in 2007 many studies have demonstrated the efficacy, safety and advantages of tension band plating in the paediatric age group as an alternative to corrective osteotomy.
Genu varum deformities of the leg are often associated with internal tibial torsion. The 3 major causes of pediatric in-toeing are metatarsus adductus, internal tibial torsion, and femoral anteversion.
..yet, there is no enough available literature studies evaluating the amount of correction of torsional deformity after coronal plane deformity correction by 8 plate hemi epiphysiodesis.
This is the question of this study and we are trying to answer it by measuring the residual torsional deformity after achieving full correction of coronal plane deformity by 8 plate hemi epiphysiodesis.
- Conditions
- Paediatric Surgery
- Being tested
- 8 plate hemiepiphysiodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 plate hemiepiphysiodesisProcedure or surgery
surgical procedure by lateral incision in proximal tibia and distal femur and fixation by using 8 plate and screws.
| Study group | Role | What they receive |
|---|---|---|
| skeletally immature patients between 2.5 : 12 years with genu varum | Active comparator | skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral) ..those will be treated by 8 plate hemi epiphysiodesis. Receives: Procedure: 8 plate hemiepiphysiodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual torsional deformity measured via clinical examination.
clinical examination by measuring : thigh foot angle - foot progression angle - heel bisector - internal and external rotaion of the hip
Measured: 1 year
Secondary outcomes (1)
Any complications detected
Follow up of the patient postoperatively and clinical examination. Number of participants with any complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study startJan 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Paediatric SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Model description
- skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral)
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Nasseh Hafeez Boles, Assiut University
- Investigators
- Hesham Elbaseet, Doctor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334862
- Sponsor's protocol ID
- 8 plate in genu varum
- Status last verified
- Dec 2024
- First submitted
- 28 Mar 2022
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Publications
Ozdemir E, Emet A, Ramazanov R, Yilmaz G. Correction of coronal plane deformities around knee in children with two-hole tension band plates. Jt Dis Relat Surg. 2021;32(1):177-184. doi: 10.5606/ehc.2021.78879. Epub 2021 Jan 6.
PubMed 33463434Heflin JA, Ford S, Stevens P. Guided growth for tibia vara (Blount's disease). Medicine (Baltimore). 2016 Oct;95(41):e4951. doi: 10.1097/MD.0000000000004951.
PubMed 27741108
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Torsional Deformity in Pediatric Genu Varum After Coronal Plane Deformity Correction by 8 Plate Hemi Epiphysiodesis.
- ClinicalTrials.gov ID
- NCT05334862
- Acronym / sponsor ID
- 8 plate in genu varum
- Conditions
- Paediatric Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 19 Apr 2022 (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.
This study is to evaluate the residual torsional deformity in pediatric Genu Varum after coronal plane deformity correction by 8 plate hemi epiphysiodesis.
Detailed description
Angular deformities around the knee in children is a common finding including genu valgum and genu varum.
The genu valgum or varum may be idiopathic or arise from diverse etiologies, such as trauma, dysplasia, metabolic disease, inflammatory, endocrine, tumor, neoplastic, or developmental pathologies.
Surgical treatment options include osteotomies with either acute or gradual correction and temporary hemi epiphysiodesis (guided growth),the latter being less invasive and with significantly lower rate of major complications.
Guided growth by 8 plate hemi epiphysiodesis is commonly used to correct coronal plane deformity around the knee. Since its introduction by Stevens in 2007 many studies have demonstrated the efficacy, safety and advantages of tension band plating in the paediatric age group as an alternative to corrective osteotomy.
Genu varum deformities of the leg are often associated with internal tibial torsion. The 3 major causes of pediatric in-toeing are metatarsus adductus, internal tibial torsion, and femoral anteversion.
..yet, there is no enough available literature studies evaluating the amount of correction of torsional deformity after coronal plane deformity correction by 8 plate hemi epiphysiodesis.
This is the question of this study and we are trying to answer it by measuring the residual torsional deformity after achieving full correction of coronal plane deformity by 8 plate hemi epiphysiodesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral)
| Arm | Type | Receives |
|---|---|---|
| skeletally immature patients between 2.5 : 12 years with genu varum | Active comparator | Procedure: 8 plate hemiepiphysiodesisskeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral) ..those will be treated by 8 plate hemi epiphysiodesis. |
Who may qualify
- Ages
- 30 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| 8 plate hemiepiphysiodesissurgical procedure by lateral incision in proximal tibia and distal femur and fixation by using 8 plate and screws. | Procedure or surgery | skeletally immature patients between 2.5 : 12 years with genu varum |
Primary outcome
residual torsional deformity measured via clinical examination.
Time frame: 1 year
clinical examination by measuring : thigh foot angle - foot progression angle - heel bisector - internal and external rotaion of the hip
1 secondary outcome
Any complications detected
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Background: PubMed 33463434Ozdemir E, Emet A, Ramazanov R, Yilmaz G. Correction of coronal plane deformities around knee in children with two-hole tension band plates. Jt Dis Relat Surg. 2021;32(1):177-184. doi: 10.5606/ehc.2021.78879. Epub 2021 Jan 6.
- Background: PubMed 27741108Heflin JA, Ford S, Stevens P. Guided growth for tibia vara (Blount's disease). Medicine (Baltimore). 2016 Oct;95(41):e4951. doi: 10.1097/MD.0000000000004951.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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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.
Hesham Elbaseet, Doctor study director
Assiut 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 8 plate hemiepiphysiodesis in people with Paediatric Surgery, run by Assiut 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?
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: looking for participants now, as of the sponsor's last update on 30 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Boles, Resident doctor (01225078186, andrewandrew44444@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
residual torsional deformity measured via clinical examination. (time frame: 1 year). 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 NCT05334862, which also lists 2 linked publications.
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 30 Dec 2024.