Genu VarumNCT06630975
Hemiepiphysiodesis by Eight Plate Versus Osteotomy in the Management of Pediatric Coronal Knee Deformities
A study testing Hemiepiphysiodesis, Eight-Plates first described by Stevens are simple to use and Hemiepiphysiodesis by eight Plate in people with Genu Varum, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery.These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Genu Varum
- What is being tested?
- Hemiepiphysiodesis, Eight-Plates first described by Stevens are simple to use and Hemiepiphysiodesis by eight Plate
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2024to 1 Oct 2025
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Growth plate still open at Time of Surgery
Who cannot join
- Epiphyseal plate involved in trauma resulting in a bridging callus formation,
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohammad Osama Hamdy
Asyut
mohamed Osama, 01094394135, zz1234213@gmail.com
Ahmed Khashaba, 01023233949, doctorahmedkhashaba@gmail.com
About this study
Official title: Resident at AlAzhar University Assuit
Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery.These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Persistent coronal plane deformities around knee (genu varum/valgum) could lead to meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption
Read the detailed description
Eight-Plates first described by Stevens are simple to use .Moreover, owing to the flexible screw/plate connection, fewer complications in terms of implant loosening and fracture can be expected.Good results aswell as low reboundand complication rates have been recorded for the first series of cases
- Conditions
- Genu Varum
- Being tested
- Hemiepiphysiodesis, Eight-Plates first described by Stevens are simple to use, Hemiepiphysiodesis by eight Plate
- Medical subject headings
- Genu Varum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemiepiphysiodesisDevice
8 plate
Eight-Plates first described by Stevens are simple to useProcedure or surgery
fewer complications in terms of implant loosening and fracture can be expected.Good results as well as low rebound and complication rates have been recorded
Hemiepiphysiodesis by eight PlateDevice
Extraperiosteal eight plate insertion
| Study group | Role | What they receive |
|---|---|---|
| Comparative Study between Growth guided Correction By ( 8 Plate ) | Experimental | Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery. Receives: Device: Hemiepiphysiodesis; Procedure: Eight-Plates first described by Stevens are simple to use; Device: Hemiepiphysiodesis by eight Plate |
| Clinical ,Radiological of Comparison the Result of Growth guided Correction to Osteoclasis in mana | Other | These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Valgus deformities in excess of 10* can cause anterior knee pain, circumduction gait, and occasionally patellofemoral instability. Varus deformities may result in lateral thrust, ligamentous laxity, and a waddling gait , meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption Receives: Device: Hemiepiphysiodesis; Procedure: Eight-Plates first described by Stevens are simple to use; Device: Hemiepiphysiodesis by eight Plate |
| Comparison the Result of Growth guided Correction to Osteoclasis | Active comparator | These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Valgus deformities in excess of 10* can cause anterior knee pain, circumduction gait, and occasionally patellofemoral instability. Varus deformities may result in lateral thrust, ligamentous laxity, and a waddling gait , meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption Receives: Device: Hemiepiphysiodesis; Procedure: Eight-Plates first described by Stevens are simple to use; Device: Hemiepiphysiodesis by eight Plate |
| Genu Varum | Active comparator | These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Valgus deformities in excess of 10* can cause anterior knee pain, circumduction gait, and occasionally patellofemoral instability. Varus deformities may result in lateral thrust, ligamentous laxity, and a waddling gait , meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption Receives: Device: Hemiepiphysiodesis; Procedure: Eight-Plates first described by Stevens are simple to use; Device: Hemiepiphysiodesis by eight Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative Study Between Growth Guided Correction By ( 8 Plate ) and Corrective Osteoclasis in Management of Coronal Deformity of Lower Limb in Children
Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery.These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Persistent coronal plane deformities around knee (genu varum/valgum) could lead to meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption
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 posted8 Oct 2024
- Study start25 Sep 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genu VarumStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Osama Hamdy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630975
- Sponsor's protocol ID
- HEPVOMPCKD
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resident at AlAzhar University Assuit
- ClinicalTrials.gov ID
- NCT06630975
- Acronym / sponsor ID
- HEPVOMPCKD
- Conditions
- Genu Varum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 8 Oct 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.
Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery.These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Persistent coronal plane deformities around knee (genu varum/valgum) could lead to meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption
Detailed description
Eight-Plates first described by Stevens are simple to use .Moreover, owing to the flexible screw/plate connection, fewer complications in terms of implant loosening and fracture can be expected.Good results aswell as low reboundand complication rates have been recorded for the first series of cases
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Comparative Study between Growth guided Correction By ( 8 Plate ) | Experimental | Device: Hemiepiphysiodesis, Procedure: Eight-Plates first described by Stevens are simple to use, Device: Hemiepiphysiodesis by eight PlateCoronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery. |
| Clinical ,Radiological of Comparison the Result of Growth guided Correction to Osteoclasis in mana | Other | Device: Hemiepiphysiodesis, Procedure: Eight-Plates first described by Stevens are simple to use, Device: Hemiepiphysiodesis by eight PlateThese angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Valgus deformities in excess of 10* can cause anterior knee pain, circumduction gait, and occasionally patellofemoral instability. Varus deformities may result in lateral thrust, ligamentous laxity, and a waddling gait , meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption |
| Comparison the Result of Growth guided Correction to Osteoclasis | Active comparator | Device: Hemiepiphysiodesis, Procedure: Eight-Plates first described by Stevens are simple to use, Device: Hemiepiphysiodesis by eight PlateThese angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Valgus deformities in excess of 10* can cause anterior knee pain, circumduction gait, and occasionally patellofemoral instability. Varus deformities may result in lateral thrust, ligamentous laxity, and a waddling gait , meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption |
| Genu Varum | Active comparator | Device: Hemiepiphysiodesis, Procedure: Eight-Plates first described by Stevens are simple to use, Device: Hemiepiphysiodesis by eight PlateThese angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Valgus deformities in excess of 10* can cause anterior knee pain, circumduction gait, and occasionally patellofemoral instability. Varus deformities may result in lateral thrust, ligamentous laxity, and a waddling gait , meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Growth plate still open at Time of Surgery
Key exclusion criteria (1 listed)
- Epiphyseal plate involved in trauma resulting in a bridging callus formation,
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 |
|---|---|---|
| Hemiepiphysiodesis8 plate | Device | Clinical ,Radiological of Comparison the Result of Growth guided Correction to Osteoclasis in mana, Comparative Study between Growth guided Correction By ( 8 Plate ), Comparison the Result of Growth guided Correction to Osteoclasis, Genu Varum |
| Eight-Plates first described by Stevens are simple to usefewer complications in terms of implant loosening and fracture can be expected.Good results as well as low rebound and complication rates have been recorded | Procedure or surgery | Clinical ,Radiological of Comparison the Result of Growth guided Correction to Osteoclasis in mana, Comparative Study between Growth guided Correction By ( 8 Plate ), Comparison the Result of Growth guided Correction to Osteoclasis, Genu Varum |
| Hemiepiphysiodesis by eight PlateExtraperiosteal eight plate insertion | Device | Clinical ,Radiological of Comparison the Result of Growth guided Correction to Osteoclasis in mana, Comparative Study between Growth guided Correction By ( 8 Plate ), Comparison the Result of Growth guided Correction to Osteoclasis, Genu Varum |
Primary outcome
Comparative Study Between Growth Guided Correction By ( 8 Plate ) and Corrective Osteoclasis in Management of Coronal Deformity of Lower Limb in Children
Time frame: 1 year
Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery.These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Persistent coronal plane deformities around knee (genu varum/valgum) could lead to meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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.
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, Eight-Plates first described by Stevens are simple to use and Hemiepiphysiodesis by eight Plate in people with Genu Varum, run by Al-Azhar 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 1 inclusion and 1 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 8 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative Study Between Growth Guided Correction By ( 8 Plate ) and Corrective Osteoclasis in Management of Coronal Deformity of Lower Limb in Children (time frame: 1 year). 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 8 Oct 2024.