- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07548749
Comparison of Transphyseal Screws and Eight Plates in Hemiepiphysiodesis for Coronal Knee Deformities: Short-Term Results
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 .
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hossam Hosny omar Mansour
- Phone Number: +201032366753
- Email: Hossamhosny00000@gmail.com
Study Locations
-
-
-
Sohag, Egypt
- Sohag faculty of medicine
-
Contact:
- Marwan shams
- Phone Number: +20 10 63196414
- Email: Marwanshams2244@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Go for transphyseal screws
|
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.
|
|
Active Comparator: Go for eight plates
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
correction of deformity
Time Frame: 6 months after surgery
|
6 months after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Soh-Med-26-3-3MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronal Deformities Around the Knee
-
Sohag UniversityNot yet recruitingDeformities Around the Knee in PedietricsEgypt
-
Nader Ahmed Sayed AbdelhamedRecruitingKnee Phenotype Changes After THA | Coronal Plane Alignment of the KneeEgypt
-
Riphah International UniversityCompletedDisability and Pain Around the Coccyx | Diagnosed With CoccydyniaPakistan
-
Seneque SAEurofins; LGDCompletedFatigue | Wrinkle | Puffiness Around the EyesUnited States, China
-
Tomas LinkeviciusCompletedDental Implant | Tooth Extractions | Primary Stability of the Implants | Marginal Bone Loss Around ImplantsLithuania
-
Mohammed Elrabie AhmedCompletedSuperficial Cyst or Mass and Sinus on and Around the EarEgypt
-
Lawson Health Research InstituteNot yet recruitingPeriprosthetic Fracture Around Prosthetic Joint Implant Knee
-
Gazi UniversityCompletedKnee Osteoarthritis | Foot Deformities | Disability Physical | Pes Planus | Knee Pain Chronic | Lower Limb Deformity | Pes CavusTurkey
-
Unity Health TorontoMount Sinai Hospital, CanadaRecruitingKnee Fracture | Distal Femur Fracture | Periprosthetic Fracture Around Prosthetic Joint Implant KneeCanada
-
Poitiers University HospitalCompletedIdentification of the Mother or Fetus Contamination by SARS Cov-2 | Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father | The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes | Analysis Laboratories of the Poitiers...France
Clinical Trials on hemiepiphysiodesis
-
Aarhus University HospitalUnknown
-
Assiut UniversityRecruiting
-
Al-Azhar UniversityRecruiting
-
SpineForm LLCChildren's Hospital Medical Center, Cincinnati; University Hospitals Cleveland...Completed
-
Assiut UniversityCompleted
-
Fundación para la investigación biomética Hospital...Hospital General Universitario Gregorio Marañon; Hospital Son Espases; Hospital... and other collaboratorsRecruiting