Developmental Hip Dysplasia by Ultrasonographic Screening of Asymptomatic Infants at Assiut University Hospital

March 23, 2018 updated by: Sondos Hassan, Assiut University

Incidence of Developmental Hip Dysplasia by Ultrasonographic Screening of Asymptomatic Infants Less Than 6 Months Old at Assiut University Hospital Outpatient Clinics

Developmental dysplasia of the hip (DDH), formerly known as congenital dislocation of the hip, comprises a spectrum of abnormalities that include abnormal acetabular shape (dysplasia) and malposition of the femoral head.

Study Overview

Status

Completed

Conditions

Detailed Description

The origin and pathogenesis of DDH are multifactorial. Abnormal laxity of the ligaments and hip capsule is seen in patients with DDH. The maternal hormone relaxin may also be a factor. Extreme hip flexion with knee extension, as in the breech position, tends to promote femoral head dislocation and leads to the shortening and contracture of the iliopsoas muscle.

It was previously reported that DDH was the underlying aetiology in about 25 % of the performed hip replacements under the age of 40 years and the initial diagnosis age ranged from 0 to 39 years, with a mean of 8 years in these patients.

The main purpose of a newborn hip screening program is to detect DDH as early as possible, so that early treatment can be given and the need for surgical treatment as well as the development of residual hip dysplasia can be avoided.

Ultrasonography offers distinct advantages compared with other imaging techniques: unlike plain radiography, it can distinguish the cartilaginous components of the acetabulum and the femoral head from other soft tissue structures, real-time US permits multiplanar examinations that can early determine the position of the femoral head in respect to the acetabulum; thus it provides the same type of information that can be obtained with arthrography, computerized tomography, or magnetic resonance imaging, but at lower cost, although ultrasonography is more expensive than plain radiography, it doesn't require sedation and doesn't involve ionizing radiation, unlike other techniques and it allows observation of changes in hip position with movement.

Study Type

Observational

Enrollment (Actual)

330

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All infants under the age of 6 months attending Pediatric Orthopedic outpatient clinics at Assiut university hospital in the period between 1st of January 2017 to 30th of December 2017.

Description

Inclusion Criteria:

  • All infants under the age of 6 months attending Pediatric Orthopedic outpatient clinics at Assiut university hospital in the period between 1st of January 2017 to 30th of December 2017.

Exclusion Criteria:

  • Age older than 6 months
  • Having any hip joint complaints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
screened infants
Asymptomatic infants under age of 6 months, presenting to the pediatric orthopaedic outpatient clinic at Assiut university hospital for other problems will be subjected to ultrasound examination of the hip joint.
US examination by US machine , Midray model DP-2200 made in China , with a high frequency (5-10 MHZ) linear transducer using the previously described Graf method for assessment of both hip joints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The alpha and the beta angels of the hip by ultrasound
Time Frame: baseline
The α-angle is a measure of acetabular depth and is the angle formed between the acetabular roof and vertical cortex of the ilium. The beta angle is the angle formed between the vertical cortex of the ilium and triangular labral fibrocartilage, It represents the acetabular cartilaginous roof modeling
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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