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Outcome Of Using Transfixing K Wire ln DDH With Hypoplastic Head And Severe Generalised Ligamentous Laxity

Primary Purpose

Developmental Dysplasia of the Hip

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Kirschner wire

About this trial

This is an interventional treatment trial for Developmental Dysplasia of the Hip focused on measuring Developmental dysplasia of the study, Kirschner wire, Hypoplastic Head, Ligamentous laxity

Eligibility Criteria

1 Year - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

K-wire

Arm Description

k wire transfixing hip

Outcomes

Primary Outcome Measures

Modified McKay's criteria

degree of Hip function score

Secondary Outcome Measures

Complications

pain, pin tract infection and recurrent dislocation

Full Information

NCT ID

NCT05822700

First Posted

March 28, 2023

Last Updated

April 20, 2023

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05822700

Brief Title

Outcome Of Using Transfixing K Wire ln DDH With Hypoplastic Head And Severe Generalised Ligamentous Laxity

Official Title

Outcome Of Using Transfixing Hip K Wire ln Developmental Dysplasia Of Hip With Hypoplastic Head And Severe Generalised Ligamentous Laxity

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2023 (Anticipated)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Developmental Dysplasia of the Hip

Keywords

Developmental dysplasia of the study, Kirschner wire, Hypoplastic Head, Ligamentous laxity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

K-wire

Arm Type

Experimental

Arm Description

k wire transfixing hip

Intervention Type

Procedure

Intervention Name(s)

Kirschner wire

Intervention Description

Transfixing femoral head Kirschner wire

Primary Outcome Measure Information:

Title

Modified McKay's criteria

Description

degree of Hip function score

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Complications

Description

pain, pin tract infection and recurrent dislocation

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mark Ramses

Phone

+2001205739715

Mark.13257406@med.aun.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Hesham Elbaseet, Professor

Phone

+20 100 778 0689

Drhesham20@aun.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hesham Elbaseet, Professor

Organizational Affiliation

Assiut University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32244273

Citation

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.

Results Reference

background

PubMed Identifier

21415680

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.

Results Reference

background

PubMed Identifier

15815903

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.

Results Reference

background

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Outcome Of Using Transfixing K Wire ln DDH With Hypoplastic Head And Severe Generalised Ligamentous Laxity

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