Developmental Dysplasia of the HipNCT05822700
Outcome Of Using Transfixing K Wire ln DDH With Hypoplastic Head And Severe Generalised Ligamentous Laxity
A study testing Kirschner wire in people with Developmental Dysplasia of the Hip, run by Assiut University.
Trial summary
This study is to evaluate the outcome of using transfixing hip k wire in Developmental dysplastic hip in patients with hypoplastic head and severe generalised ligamentous laxity. Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- Kirschner wire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Mar 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 1 year to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients older than 1 year and younger than 7
- Patients with hypoplastic head
- Patients with severe ligamentous laxity (Beighton score ≥ 4)
Who cannot join
- Patients younger than 1 year and older than 7 years old.
- Beighton score < 4
- Secondary hip dislocation (neuromuscular disorder) as cerebral palsy , myelodysplasia or arthrogryposis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcome Of Using Transfixing Hip K Wire ln Developmental Dysplasia Of Hip With Hypoplastic Head And Severe Generalised Ligamentous Laxity
This study is to evaluate the outcome of using transfixing hip k wire in Developmental dysplastic hip in patients with hypoplastic head and severe generalised ligamentous laxity.
Read the detailed description
The goal of treatment in developmental dysplasia of the hip (DDH) is to obtain and maintain a stable concentric reduction.
Surgical treatment is done by open reduction through a medial approach or anterolateral approach with pelvic osteotomy,capsulorhaphy, femoral shortening and derotational osteotomy.
Transfixing the femoral head with Kirschner wire during open reduction has long been thought to provide stability to the hip without damaging the femoral head or the acetabulum and to decrease the risk or re-dislocation.
The aim of this study is to assess the effect of transfixing the hip with Kirschner wire during the operative treatment of hip dysplasia in children after the walking age on the final radiological and clinical results and to compare the risks with the benefits of adding this step.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- Kirschner wire
- Keywords
- Developmental dysplasia of the study, Kirschner wire, Hypoplastic Head, Ligamentous laxity
- Medical subject headings
- Developmental Dysplasia of the Hip, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kirschner wireProcedure or surgery
Transfixing femoral head Kirschner wire
| Study group | Role | What they receive |
|---|---|---|
| K-wire | Experimental | k wire transfixing hip Receives: Procedure: Kirschner wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified McKay's criteria
degree of Hip function score
Measured: 1 year
Secondary outcomes (1)
Complications
pain, pin tract infection and recurrent dislocation
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 posted21 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohamed Elbaseet, Assiut University
- Investigators
- Hesham Elbaseet, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822700
- Sponsor's protocol ID
- Developmental Dysplasia of Hip
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harsanyi S, Zamborsky R, Krajciova L, Kokavec M, Danisovic L. Developmental Dysplasia of the Hip: A Review of Etiopathogenesis, Risk Factors, and Genetic Aspects. Medicina (Kaunas). 2020 Mar 31;56(4):153. doi: 10.3390/medicina56040153.
PubMed 32244273Sankar WN, Young CR, Lin AG, Crow SA, Baldwin KD, Moseley CF. Risk factors for failure after open reduction for DDH: a matched cohort analysis. J Pediatr Orthop. 2011 Apr-May;31(3):232-9. doi: 10.1097/BPO.0b013e31820c9b31.
PubMed 21415680Kamath SU, Bennet GC. Re-dislocation following open reduction for developmental dysplasia of the hip. Int Orthop. 2005 Jun;29(3):191-4. doi: 10.1007/s00264-005-0654-6. Epub 2005 Apr 7.
PubMed 15815903
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Of Using Transfixing Hip K Wire ln Developmental Dysplasia Of Hip With Hypoplastic Head And Severe Generalised Ligamentous Laxity
- ClinicalTrials.gov ID
- NCT05822700
- Acronym / sponsor ID
- Developmental Dysplasia of Hip
- Conditions
- Developmental Dysplasia of the Hip
- Keywords
- Developmental dysplasia of the study, Kirschner wire, Hypoplastic Head, Ligamentous laxity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 21 Apr 2023 (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.
This study is to evaluate the outcome of using transfixing hip k wire in Developmental dysplastic hip in patients with hypoplastic head and severe generalised ligamentous laxity.
Detailed description
The goal of treatment in developmental dysplasia of the hip (DDH) is to obtain and maintain a stable concentric reduction.
Surgical treatment is done by open reduction through a medial approach or anterolateral approach with pelvic osteotomy,capsulorhaphy, femoral shortening and derotational osteotomy.
Transfixing the femoral head with Kirschner wire during open reduction has long been thought to provide stability to the hip without damaging the femoral head or the acetabulum and to decrease the risk or re-dislocation.
The aim of this study is to assess the effect of transfixing the hip with Kirschner wire during the operative treatment of hip dysplasia in children after the walking age on the final radiological and clinical results and to compare the risks with the benefits of adding this step.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K-wire | Experimental | Procedure: Kirschner wirek wire transfixing hip |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients older than 1 year and younger than 7
- Patients with hypoplastic head
- Patients with severe ligamentous laxity (Beighton score ≥ 4)
Key exclusion criteria (3 listed)
- Patients younger than 1 year and older than 7 years old.
- Beighton score < 4
- Secondary hip dislocation (neuromuscular disorder) as cerebral palsy , myelodysplasia or arthrogryposis.
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 |
|---|---|---|
| Kirschner wireTransfixing femoral head Kirschner wire | Procedure or surgery | K-wire |
Primary outcome
Modified McKay's criteria
Time frame: 1 year
degree of Hip function score
1 secondary outcome
Complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Background: PubMed 32244273Harsanyi S, Zamborsky R, Krajciova L, Kokavec M, Danisovic L. Developmental Dysplasia of the Hip: A Review of Etiopathogenesis, Risk Factors, and Genetic Aspects. Medicina (Kaunas). 2020 Mar 31;56(4):153. doi: 10.3390/medicina56040153.
- Background: PubMed 21415680Sankar WN, Young CR, Lin AG, Crow SA, Baldwin KD, Moseley CF. Risk factors for failure after open reduction for DDH: a matched cohort analysis. J Pediatr Orthop. 2011 Apr-May;31(3):232-9. doi: 10.1097/BPO.0b013e31820c9b31.
- Background: PubMed 15815903Kamath SU, Bennet GC. Re-dislocation following open reduction for developmental dysplasia of the hip. Int Orthop. 2005 Jun;29(3):191-4. doi: 10.1007/s00264-005-0654-6. Epub 2005 Apr 7.
- Individual participant dataSharing planned: Undecided
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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.
Hesham Elbaseet, Professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Kirschner wire in people with Developmental Dysplasia of the Hip, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mark Ramses (+2001205739715, Mark.13257406@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified McKay's criteria (time frame: 1 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 NCT05822700, which also lists 3 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 21 Apr 2023.