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OpenTrials
Completed

NCT Number: NCT03476915

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

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.

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Key information

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound examination of the hip joint

Other

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 26, 2018
Registry last updated
Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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