Orthopedic DisorderNCT03476915
Developmental Hip Dysplasia by Ultrasonographic Screening of Asymptomatic Infants at Assiut University Hospital
An observational study of Orthopedic Disorder, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- ultrasound examination of the hip joint
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Mar 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Age older than 6 months
- Having any hip joint complaints
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthopedic Disorder
- Being tested
- ultrasound examination of the hip joint
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examination of the hip jointOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ultrasound examination of the hip joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jan 2017
- Primary completion30 Dec 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 330 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sondos Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476915
- Sponsor's protocol ID
- DHD2017
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17482986Engesaeter 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.
PubMed 21434808Sewell MD, Rosendahl K, Eastwood DM. Developmental dysplasia of the hip. BMJ. 2009 Nov 24;339:b4454. doi: 10.1136/bmj.b4454. No abstract available.
PubMed 19934187Wientroub 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.
PubMed 10901315
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Developmental Hip Dysplasia by Ultrasonographic Screening of Asymptomatic Infants Less Than 6 Months Old at Assiut University Hospital Outpatient Clinics
- ClinicalTrials.gov ID
- NCT03476915
- Acronym / sponsor ID
- DHD2017
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screened infants | – | Other: ultrasound examination of the hip jointAsymptomatic 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. |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Age older than 6 months
- Having any hip joint complaints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound examination of the hip jointUS 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. | Other | screened infants |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Background: PubMed 17482986Dezateux C, Rosendahl K. Developmental dysplasia of the hip. Lancet. 2007 May 5;369(9572):1541-1552. doi: 10.1016/S0140-6736(07)60710-7.
- Background: PubMed 21434808Engesaeter 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.
- Background: PubMed 19934187Sewell MD, Rosendahl K, Eastwood DM. Developmental dysplasia of the hip. BMJ. 2009 Nov 24;339:b4454. doi: 10.1136/bmj.b4454. No abstract available.
- Background: PubMed 10901315Wientroub 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The alpha and the beta angels of the hip by ultrasound (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03476915, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.