Tibia Vara in ChildrenNCT07400705
Short-term Outcomes of High Tibial Osteotomy Using a Plate Versus a Plate With an Interbody Fusion Cage in Adolescent Tibia Vara : a Comparative Study
A study testing high tibial osteotomy using interbody fusion cage in people with Tibia Vara in Children, run by Sohag University at 1 site in Egypt.
Trial summary
Tibia vara is a progressive angular deformity of the lower limb centered at the proximal tibial physis, producing a characteristic bowing of the leg. The condition is believed to result from an abnormal distribution of biomechanical stresses combined with an underlying genetic predisposition. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Tibia Vara in Children
- What is being tested?
- high tibial osteotomy using interbody fusion cage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2025to 6 Oct 2026
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents aged [10-18] years diagnosed with tibia vara.
- Symptomatic varus deformity centered at the proximal tibia requiring surgical correction.
- Both sexes included
- Open or transitional growth plates are suitable for HTO.
Who cannot join
- Prior tibial realignment surgery on the same side.
- Ages below 10 years or above 18 years
- Active infection, progressive metabolic disorder (e.g., rickets) or skeletal dysplasia, neuromuscular disorder, or systemic inflammatory arthritis.
- Complex deformities need external fixation as the first-line treatment.
- Patients with chronic comorbidities.
- Associated with fractures in the same limb
Trial locations and contacts
1 site in 1 country.
About this study
Tibia vara is a progressive angular deformity of the lower limb centered at the proximal tibial physis, producing a characteristic bowing of the leg. The condition is believed to result from an abnormal distribution of biomechanical stresses combined with an underlying genetic predisposition. (1) Excessive mechanical loading on the medial portion of the proximal tibial growth plate leads to asymmetric physeal activity, ultimately causing a pathologic varus deformity of the tibia.(²)
Read the detailed description
The adolescent tibia vara may affect one or both limbs and is typically identified during or shortly before the pubertal growth spurt. (1) It is more frequently reported among individuals of African descent and those with a body mass index (BMI) greater than 40. (2) The increased body weight in these patients accentuates compressive forces on the posteromedial aspect of the proximal tibial physis,(3) resulting in localized inhibition of growth according to the Heuter-Volkmann principle, and leading to progressive varus deformity.(4) In many cases, associated deformities may also be observed at the distal tibia or femur, presenting as either varus or valgus alignment abnormalities.(5) Given the mechanical and structural nature of this deformity, corrective high tibial osteotomy (HTO) remains the cornerstone of surgical management in adolescent tibia vara. Modern fixation methods particularly the use of plate fixation versus plate combined with interbody fusion cage are being explored to enhance alignment correction, stability, and long-term outcomes in this challenging age group.
- Conditions
- Tibia Vara in Children
- Being tested
- high tibial osteotomy using interbody fusion cage
- Keywords
- Tibia vara is a progressive angular deformity of the lower limb centered at the proximal tibial physis, producing a characteristic bowing of the leg.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tibial osteotomy using interbody fusion cageProcedure or surgery
correction of adolescent tibia vara with high tibial osteotomy using interbody fusion cage
| Study group | Role | What they receive |
|---|---|---|
| Group A: Corrective HTO with plate fixation only. | Active comparator | Not described Receives: Procedure: high tibial osteotomy using interbody fusion cage |
| Group B: Corrective HTO with plate fixation plus an interbody fusion cage. | Active comparator | Not described Receives: Procedure: high tibial osteotomy using interbody fusion cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
correction of tibia vara radiologically
Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.
Measured: 6 months
correction of tibia vara on radiographs
Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start6 Oct 2025
- Primary completion6 Oct 2025
- Study completion6 Oct 2026 (estimated)
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 Tibia Vara in ChildrenStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Ahmed Hafez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400705
- Sponsor's protocol ID
- Soh-Med-26-1-3MS
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data and related study documents (protocol, CRF, SAP) will be made available upon reasonable request. Data will be accessible starting 6 months after the main results publication and will remain available for at least 5 years. Access will be granted to qualified researchers after approval of a research proposal and completion of a data sharing agreement. Data will be stored in a secure, publicly accessible repository
Publications
Jang SH, Chang CH, Jung YJ, Kwon HG. Hypersomnia due to injury of the ventral ascending reticular activating system following cerebellar herniation: A case report. Medicine (Baltimore). 2017 Jan;96(1):e5678. doi: 10.1097/MD.0000000000005678.
PubMed 28072702
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcomes of High Tibial Osteotomy Using a Plate Versus a Plate With an Interbody Fusion Cage in Adolescent Tibia Vara : a Comparative Study
- ClinicalTrials.gov ID
- NCT07400705
- Acronym / sponsor ID
- Soh-Med-26-1-3MS
- Conditions
- Tibia Vara in Children
- Keywords
- Tibia vara is a progressive angular deformity of the lower limb centered at the proximal tibial physis, producing a characteristic bowing of the leg.
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2026 (estimated)
- First posted
- 10 Feb 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.
Tibia vara is a progressive angular deformity of the lower limb centered at the proximal tibial physis, producing a characteristic bowing of the leg. The condition is believed to result from an abnormal distribution of biomechanical stresses combined with an underlying genetic predisposition. (1) Excessive mechanical loading on the medial portion of the proximal tibial growth plate leads to asymmetric physeal activity, ultimately causing a pathologic varus deformity of the tibia.(²)
Detailed description
The adolescent tibia vara may affect one or both limbs and is typically identified during or shortly before the pubertal growth spurt. (1) It is more frequently reported among individuals of African descent and those with a body mass index (BMI) greater than 40. (2) The increased body weight in these patients accentuates compressive forces on the posteromedial aspect of the proximal tibial physis,(3) resulting in localized inhibition of growth according to the Heuter-Volkmann principle, and leading to progressive varus deformity.(4) In many cases, associated deformities may also be observed at the distal tibia or femur, presenting as either varus or valgus alignment abnormalities.(5) Given the mechanical and structural nature of this deformity, corrective high tibial osteotomy (HTO) remains the cornerstone of surgical management in adolescent tibia vara. Modern fixation methods particularly the use of plate fixation versus plate combined with interbody fusion cage are being explored to enhance alignment correction, stability, and long-term outcomes in this challenging age group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Corrective HTO with plate fixation only. | Active comparator | Procedure: high tibial osteotomy using interbody fusion cage |
| Group B: Corrective HTO with plate fixation plus an interbody fusion cage. | Active comparator | Procedure: high tibial osteotomy using interbody fusion cage |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescents aged [10-18] years diagnosed with tibia vara.
- Symptomatic varus deformity centered at the proximal tibia requiring surgical correction.
- Both sexes included
- Open or transitional growth plates are suitable for HTO.
Key exclusion criteria (6 listed)
- Prior tibial realignment surgery on the same side.
- Ages below 10 years or above 18 years
- Active infection, progressive metabolic disorder (e.g., rickets) or skeletal dysplasia, neuromuscular disorder, or systemic inflammatory arthritis.
- Complex deformities need external fixation as the first-line treatment.
- Patients with chronic comorbidities.
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 |
|---|---|---|
| high tibial osteotomy using interbody fusion cagecorrection of adolescent tibia vara with high tibial osteotomy using interbody fusion cage | Procedure or surgery | Group A: Corrective HTO with plate fixation only., Group B: Corrective HTO with plate fixation plus an interbody fusion cage. |
Primary outcome
correction of tibia vara radiologically
Time frame: 6 months
Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.
correction of tibia vara on radiographs
Time frame: 6 months
Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.
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 10 Feb 2026.
- Background: PubMed 28072702Jang SH, Chang CH, Jung YJ, Kwon HG. Hypersomnia due to injury of the ventral ascending reticular activating system following cerebellar herniation: A case report. Medicine (Baltimore). 2017 Jan;96(1):e5678. doi: 10.1097/MD.0000000000005678.
- Anteromedial incision , osteotomy cut and open using laminar spreader then insert suitable size cage and apply plateLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data and related study documents (protocol, CRF, SAP) will be made available upon reasonable request. Data will be accessible starting 6 months after the main results publication and will remain available for at least 5 years. Access will be granted to qualified researchers after approval of a research proposal and completion of a data sharing agreement. Data will be stored in a secure, publicly accessible repository
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?
A study testing high tibial osteotomy using interbody fusion cage in people with Tibia Vara in Children, 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 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?
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?
correction of tibia vara radiologically (time frame: 6 months). The study lists 2 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 NCT07400705, 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 10 Feb 2026.