- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05822700
Outcome Of Using Transfixing K Wire ln DDH With Hypoplastic Head And Severe Generalised Ligamentous Laxity
Outcome Of Using Transfixing Hip K Wire ln Developmental Dysplasia Of Hip With Hypoplastic Head And Severe Generalised Ligamentous Laxity
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mark Ramses
- Phone Number: +2001205739715
- Email: Mark.13257406@med.aun.edu.eg
Study Contact Backup
- Name: Hesham Elbaseet, Professor
- Phone Number: +20 100 778 0689
- Email: Drhesham20@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients older than 1 year and younger than 7
- Patients with hypoplastic head
- Patients with severe ligamentous laxity (Beighton score ≥ 4)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: K-wire
k wire transfixing hip
|
Transfixing femoral head Kirschner wire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified McKay's criteria
Time Frame: 1 year
|
degree of Hip function score
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: 1 year
|
pain, pin tract infection and recurrent dislocation
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hesham Elbaseet, Professor, Assiut University
Publications and helpful links
General 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.
- Sankar 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.
- Kamath 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Developmental Dysplasia of Hip
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.
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