NCT03476915

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Status
completed

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

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

12 months

First QC Date

March 20, 2018

Last Update Submit

March 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The alpha and the beta angels of the hip by ultrasound

    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

Study Arms (1)

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.

Other: ultrasound examination of the hip joint

Interventions

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.

screened infants

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Dezateux C, Rosendahl K. Developmental dysplasia of the hip. Lancet. 2007 May 5;369(9572):1541-1552. doi: 10.1016/S0140-6736(07)60710-7.

    PMID: 17482986BACKGROUND
  • Engesaeter IO, Lehmann T, Laborie LB, Lie SA, Rosendahl K, Engesaeter LB. Total hip replacement in young adults with hip dysplasia: age at diagnosis, previous treatment, quality of life, and validation of diagnoses reported to the Norwegian Arthroplasty Register between 1987 and 2007. Acta Orthop. 2011 Apr;82(2):149-54. doi: 10.3109/17453674.2011.566146. Epub 2011 Mar 24.

    PMID: 21434808BACKGROUND
  • Sewell MD, Rosendahl K, Eastwood DM. Developmental dysplasia of the hip. BMJ. 2009 Nov 24;339:b4454. doi: 10.1136/bmj.b4454. No abstract available.

    PMID: 19934187BACKGROUND
  • Wientroub S, Grill F. Ultrasonography in developmental dysplasia of the hip. J Bone Joint Surg Am. 2000 Jul;82-A(7):1004-18. doi: 10.2106/00004623-200007000-00012. No abstract available.

    PMID: 10901315BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 26, 2018

Study Start

January 1, 2017

Primary Completion

December 30, 2017

Study Completion

March 1, 2018

Last Updated

March 26, 2018

Record last verified: 2018-03