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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05822700
Other study ID # Developmental Dysplasia of Hip
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2023
Est. completion date March 2025

Study information

Verified date April 2023
Source Assiut University
Contact Mark Ramses
Phone +2001205739715
Email Mark.13257406@med.aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date March 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 7 Years
Eligibility Inclusion Criteria: 1. Patients older than 1 year and younger than 7 2. Patients with hypoplastic head 3. Patients with severe ligamentous laxity (Beighton score = 4) Exclusion Criteria: 1. Patients younger than 1 year and older than 7 years old. 2. Beighton score < 4 3. Secondary hip dislocation (neuromuscular disorder) as cerebral palsy , myelodysplasia or arthrogryposis.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Kirschner wire
Transfixing femoral head Kirschner wire

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Modified McKay's criteria degree of Hip function score 1 year
Secondary Complications pain, pin tract infection and recurrent dislocation 1 year
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