Deformities Around the Knee in PedietricsNCT05331677
Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator
A study testing correction of deformities around the knee with external fixator in people with Deformities Around the Knee in Pedietrics, run by Sohag University at 1 site in Egypt.
Trial summary
Angular deformities around the knee are one of the common cause of presentation at pediatric orthopedic clinic. Although these conditions are commonly benign and self-limiting. The mechanical axis of the lower extremity is a straight line extending from the center of the femoral head to the center of the ankle. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Deformities Around the Knee in Pedietrics
- What is being tested?
- correction of deformities around the knee with external fixator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2022to Apr 2023
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Genu valgus having tibio-femoral angle more than 15 degrees.
- Genu varus having metaphyseal-diaphyseal angle of more than 11 degrees
- More than one plane defirmity
- Age 10 - 16 yrs
- Range of motion:
- Full extension
- More than 100 in flextion
Who cannot join
- Genu recurvatum.
- Flexion deformity.
- Pathological conditions (e.g: bone softening diseases
- Dysplasia
- Limb length discrepancy
Trial locations and contacts
1 site in 1 country.
Ahmed i addosooki, professor contact
About this study
Angular deformities around the knee are one of the common cause of presentation at pediatric orthopedic clinic. Although these conditions are commonly benign and self-limiting.
The mechanical axis of the lower extremity is a straight line extending from the center of the femoral head to the center of the ankle. The horizontal distance in millimeters from the center of the knee joint to the mechanical axis is the deviation of the mechanical axis.
The goal of treatment is to correct malalignment of the lower extremity and perhaps to prevent or delay the onset of osteoarthritis by normalizing the mechanical axis
- Being tested
- correction of deformities around the knee with external fixator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
correction of deformities around the knee with external fixatorProcedure or surgery
minimally invasive surgery
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Procedure: correction of deformities around the knee with external fixator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoresen scoring system
- Malaligment varus/valgus procurvatum/retrocurvatum internal/external rotation
- Range of motion flextion extension deficit pain and swelling
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (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 Deformities Around the Knee in PedietricsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed mahmoud eldeeb, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331677
- Sponsor's protocol ID
- Soh-Med-22-03-07
- Status last verified
- Apr 2022
- First submitted
- 18 Mar 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Espandar R, Mortazavi SM, Baghdadi T. Angular deformities of the lower limb in children. Asian J Sports Med. 2010 Mar;1(1):46-53. doi: 10.5812/asjsm.34871.
PubMed 22375192Edgerton BC, Mariani EM, Morrey BF. Distal femoral varus osteotomy for painful genu valgum. A five-to-11-year follow-up study. Clin Orthop Relat Res. 1993 Mar;(288):263-9.
PubMed 8458142
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator
- ClinicalTrials.gov ID
- NCT05331677
- Acronym / sponsor ID
- Soh-Med-22-03-07
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 18 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.
Angular deformities around the knee are one of the common cause of presentation at pediatric orthopedic clinic. Although these conditions are commonly benign and self-limiting.
The mechanical axis of the lower extremity is a straight line extending from the center of the femoral head to the center of the ankle. The horizontal distance in millimeters from the center of the knee joint to the mechanical axis is the deviation of the mechanical axis.
The goal of treatment is to correct malalignment of the lower extremity and perhaps to prevent or delay the onset of osteoarthritis by normalizing the mechanical axis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: correction of deformities around the knee with external fixator |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Genu valgus having tibio-femoral angle more than 15 degrees.
- Genu varus having metaphyseal-diaphyseal angle of more than 11 degrees
- More than one plane defirmity
- Age 10 - 16 yrs
- Range of motion:
Key exclusion criteria (5 listed)
- Genu recurvatum.
- Flexion deformity.
- Pathological conditions (e.g: bone softening diseases
- Dysplasia
- Limb length discrepancy
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 |
|---|---|---|
| correction of deformities around the knee with external fixatorminimally invasive surgery | Procedure or surgery | study group |
Primary outcome
Thoresen scoring system
Time frame: one year
* Malaligment varus/valgus procurvatum/retrocurvatum internal/external rotation * Range of motion flextion extension deficit pain and swelling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Background: PubMed 22375192Espandar R, Mortazavi SM, Baghdadi T. Angular deformities of the lower limb in children. Asian J Sports Med. 2010 Mar;1(1):46-53. doi: 10.5812/asjsm.34871.
- Background: PubMed 8458142Edgerton BC, Mariani EM, Morrey BF. Distal femoral varus osteotomy for painful genu valgum. A five-to-11-year follow-up study. Clin Orthop Relat Res. 1993 Mar;(288):263-9.
- Individual participant dataSharing planned: Yes
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.
Ahmed i addosooki, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing correction of deformities around the knee with external fixator in people with Deformities Around the Knee in Pedietrics, 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 7 inclusion and 5 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 18 Apr 2022. 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?
Contact mohamed m eldeeb, resident doctor (01062851905, mohamed011166@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoresen scoring system (time frame: one 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 NCT05331677, 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 18 Apr 2022.