Coronal Deformities Around the KneeNCT07548749
Comparison of Transphyseal Screws and Eight Plates in Hemiepiphysiodesis for Coronal Knee Deformities: Short-Term Results
A study testing hemiepiphysiodesis in people with Coronal Deformities Around the Knee, run by Sohag University at 1 site in Egypt.
Trial summary
Coronal angular deformities of the lower limbs, such as bow legs and knock-knees, are frequently observed in childhood. While many cases are considered normal and resolve on their own, when these deformities become significant and progressive, they can disrupt the quality of life, leading to gait disturbances, pain… Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Coronal Deformities Around the Knee
- What is being tested?
- hemiepiphysiodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- May 2026to Apr 2027
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both gender (males and females)
- Children ≥3 years old and growing children 2 years at least remaining in growth ( skeletal immature)
- Cases with progressive knee deformities around knee at any side.
Who cannot join
- 1. Physeal closure.
- 2. Physiological deformity in younger ages that could be managed conservatively ( age < 3 years )
- 3. Cases with metabolic or chronic illness conditions unresolved.
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
Sohag faculty of medicine
Sohag
Marwan shams, +20 10 63196414, Marwanshams2244@gmail.com
About this study
Official title: Management of Coronal Deformities Around the Knee With Hemiepiphysiodesis Using Transphyseal Screws Versus Eight Plates , Short Term Results
Coronal angular deformities of the lower limbs, such as bow legs and knock-knees, are frequently observed in childhood. While many cases are considered normal and resolve on their own, when these deformities become significant and progressive, they can disrupt the quality of life, leading to gait disturbances, pain, and in severe instances, joint instability. Additionally, these deformities may have indirect effects on other joints like the hip and ankle, and most importantly, they increase the risk of early osteoarthritis in the knee .
It is generally accepted that a significant deformity that persists up to preadolescence will not correct spontaneously. Physiological alignment of the lower limb is crucial for the symmetrical distribution of weight over the surfaces of the joints, especially the knee. Indeed, severe coronal malalignment has been linked to knee pain, altered gait, and occasionally patellofemoral problems .
- Conditions
- Coronal Deformities Around the Knee
- Being tested
- hemiepiphysiodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemiepiphysiodesisProcedure or surgery
Hemiepiphysiodesis is a safe, effective, and minimally invasive method for correcting angular deformities in growing children. The two main techniques-transphyseal screw and eight-plate-both rely on guided growth principles but differ in mechanics, control, and risk profile. Careful patient selection, timing, and follow-up are key to achieving optimal results.
| Study group | Role | What they receive |
|---|---|---|
| Go for transphyseal screws | Active comparator | Not described Receives: Procedure: hemiepiphysiodesis |
| Go for eight plates | Active comparator | Not described Receives: Procedure: hemiepiphysiodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
correction of deformity
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronal Deformities Around the KneeStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Hosny Omar, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548749
- Sponsor's protocol ID
- Soh-Med-26-3-3MS
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Coronal Deformities Around the Knee With Hemiepiphysiodesis Using Transphyseal Screws Versus Eight Plates , Short Term Results
- ClinicalTrials.gov ID
- NCT07548749
- Acronym / sponsor ID
- Soh-Med-26-3-3MS
- Conditions
- Coronal Deformities Around the Knee
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 Apr 2026 (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.
Coronal angular deformities of the lower limbs, such as bow legs and knock-knees, are frequently observed in childhood. While many cases are considered normal and resolve on their own, when these deformities become significant and progressive, they can disrupt the quality of life, leading to gait disturbances, pain, and in severe instances, joint instability. Additionally, these deformities may have indirect effects on other joints like the hip and ankle, and most importantly, they increase the risk of early osteoarthritis in the knee .
It is generally accepted that a significant deformity that persists up to preadolescence will not correct spontaneously. Physiological alignment of the lower limb is crucial for the symmetrical distribution of weight over the surfaces of the joints, especially the knee. Indeed, severe coronal malalignment has been linked to knee pain, altered gait, and occasionally patellofemoral problems .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Go for transphyseal screws | Active comparator | Procedure: hemiepiphysiodesis |
| Go for eight plates | Active comparator | Procedure: hemiepiphysiodesis |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Both gender (males and females)
- Children ≥3 years old and growing children 2 years at least remaining in growth ( skeletal immature)
- Cases with progressive knee deformities around knee at any side.
Key exclusion criteria (3 listed)
- 1. Physeal closure.
- 2. Physiological deformity in younger ages that could be managed conservatively ( age < 3 years )
- 3. Cases with metabolic or chronic illness conditions unresolved.
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 |
|---|---|---|
| hemiepiphysiodesisHemiepiphysiodesis is a safe, effective, and minimally invasive method for correcting angular deformities in growing children. The two main techniques-transphyseal screw and eight-plate-both rely on guided growth principles but differ in mechanics, control, and risk profile. Careful patient selection, timing, and follow-up are key to achieving optimal results. | Procedure or surgery | Go for eight plates, Go for transphyseal screws |
Primary outcome
correction of deformity
Time frame: 6 months after surgery
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 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemiepiphysiodesis in people with Coronal Deformities Around the Knee, run by Sohag 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 3 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: opening soon, as of the sponsor's last update on 23 Apr 2026. 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 Hossam Hosny omar Mansour (+201032366753, Hossamhosny00000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correction of deformity (time frame: 6 months after surgery). 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 23 Apr 2026.