NCT05822700

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

March 28, 2023

Last Update Submit

April 20, 2023

Conditions

Keywords

Developmental dysplasia of the studyKirschner wireHypoplastic HeadLigamentous laxity

Outcome Measures

Primary Outcomes (1)

  • Modified McKay's criteria

    degree of Hip function score

    1 year

Secondary Outcomes (1)

  • Complications

    1 year

Study Arms (1)

K-wire

EXPERIMENTAL

k wire transfixing hip

Procedure: Kirschner wire

Interventions

Transfixing femoral head Kirschner wire

K-wire

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients older than 1 year and younger than 7
  • Patients with hypoplastic head
  • Patients with severe ligamentous laxity (Beighton score ≥ 4)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 32244273BACKGROUND
  • 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.

    PMID: 21415680BACKGROUND
  • 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.

    PMID: 15815903BACKGROUND

MeSH Terms

Conditions

Developmental Dysplasia of the HipJoint Instability

Interventions

Bone Wires

Condition Hierarchy (Ancestors)

Hip DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Officials

  • Hesham Elbaseet, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 21, 2023

Study Start

May 1, 2023

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

April 21, 2023

Record last verified: 2023-04