Developmental Dysplasia of the HipNCT03608475
Assessing a Limited Ultrasound Protocol in DDH
A study testing Limited Ultrasound Imaging and Standard Ultrasound Imaging in people with Developmental Dysplasia of the Hip, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Developmental Dysplasia of the Hip (DDH) is a common diagnosis in children that if untreated may lead to degeneration and arthritis of the hip joint at a young age. Ultrasound imaging is used to monitor progress of the developing hip joint during treatment. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- Limited Ultrasound Imaging and Standard Ultrasound Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jul 2018to 10 May 2022
- Phase
- Interventional
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 0-6 months at time of diagnosis
- Clinical and Ultrasound diagnosis of stable developmental dysplasia of the hip
- Children with dislocated/ unstable DDH will be included once the hip becomes stable
- Treated with Pavlik harness
- Assessed and treated at the SickKids Baby Hip Clinic
Who cannot join
- Underlying neuromuscular disease
- Teratologic hip dysplasia
- Prior treatment at other institutions
- Non-compliance with treatment protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Inferiority Trial Assessing a Limited Ultrasound Protocol in the Treatment of Developmental Dysplasia of the Hip
Developmental Dysplasia of the Hip (DDH) is a common diagnosis in children that if untreated may lead to degeneration and arthritis of the hip joint at a young age. Ultrasound imaging is used to monitor progress of the developing hip joint during treatment. Initial data from our practice suggests that interim ultrasounds do not alter the course or outcome of treatment. Additionally, these ultrasounds add significant time to clinic visits and carry a substantial cost to the health care system. The goal of this study is to determine if limiting the number of ultrasounds during treatment results in the same outcomes while also evaluating the amount of time and money saved by omitting the ultrasounds.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- Limited Ultrasound Imaging, Standard Ultrasound Imaging
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limited Ultrasound ImagingOther
Ultrasound imaging will not be performed at the 2, 5 and 8 week clinic visits
Standard Ultrasound ImagingOther
Ultrasound imaging will be performed at all clinic visits
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Ultrasound Group | Active comparator | Children in the comprehensive ultrasound protocol group will follow the current standardized treatment protocol used at the Hospital for Sick Children in Toronto, Canada. For children presenting with stable hip dysplasia, Pavlik harness (PH) treatment is initiated at the initial visit (week 0) and runs for a total of 12 weeks. Children return to clinic at weeks 2, 5, 8 and 12 for clinical and ultrasound examinations to ensure that the harness is fitting correctly, to screen for PH complications and to monitor acetabular development. Receives: Other: Standard Ultrasound Imaging |
| Limited Ultrasound Group | Experimental | Children in the limited ultrasound protocol group will receive the same treatment as described for the comprehensive ultrasound group above, except the ultrasound imaging conducted at weeks 2, 5 and 8 will be omitted. Children will still return to clinic at 2, 5, and 8 weeks for clinical examination, which includes the assessment of the Pavlik harness fit and screening for complications. Receives: Other: Limited Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular Index
Acetabular Index will be measured on a supine anteroposterior (AP) radiograph of the pelvis
Measured: When patient reaches 1 year of age
International Hip Dysplasia Institute Score
The International Hip Dysplasia Institute (IHDI) grade will be measured from a radiograph of the pelvis. The score classifies hips into one of four groups based on the position of the proximal femoral metaphysis in relation to the acetabulum. The scores grade severity from Grade 1 as the mildest type to Grade 4 as the most severe type of hip dislocation.
Measured: When patient reaches 1 year of age
Secondary outcomes (3)
Complication Rate
The frequency of complications between the treatment groups will be compared
Measured: Through study completion, an average of two years
Health Care Costs
The difference in cost between the two treatment arms will be the cost of 3 diagnostic ultrasounds
Measured: Through study completion, an average of two years
Hospital Appointment Duration
Calculating time between registering at Ultrasound and registering at the Orthopaedic clinic will provide a measurement of time savings in the limited ultrasound protocol group
Measured: Through study completion, an average of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start27 Jul 2018
- Primary completion10 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Kelley, The Hospital for Sick Children
- Investigators
- Simon P Kelley, PhD, FRCS, Principal investigator, The Hospital for Sick Children, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608475
- Sponsor's protocol ID
- REB1000056980
- Status last verified
- Nov 2023
- First submitted
- 20 Jun 2018
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Trial Assessing a Limited Ultrasound Protocol in the Treatment of Developmental Dysplasia of the Hip
- ClinicalTrials.gov ID
- NCT03608475
- Acronym / sponsor ID
- REB1000056980
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 1 Aug 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) is a common diagnosis in children that if untreated may lead to degeneration and arthritis of the hip joint at a young age. Ultrasound imaging is used to monitor progress of the developing hip joint during treatment. Initial data from our practice suggests that interim ultrasounds do not alter the course or outcome of treatment. Additionally, these ultrasounds add significant time to clinic visits and carry a substantial cost to the health care system. The goal of this study is to determine if limiting the number of ultrasounds during treatment results in the same outcomes while also evaluating the amount of time and money saved by omitting the ultrasounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Ultrasound Group | Active comparator | Other: Standard Ultrasound ImagingChildren in the comprehensive ultrasound protocol group will follow the current standardized treatment protocol used at the Hospital for Sick Children in Toronto, Canada. For children presenting with stable hip dysplasia, Pavlik harness (PH) treatment is initiated at the initial visit (week 0) and runs for a total of 12 weeks. Children return to clinic at weeks 2, 5, 8 and 12 for clinical and ultrasound examinations to ensure that the harness is fitting correctly, to screen for PH complications and to monitor acetabular development. |
| Limited Ultrasound Group | Experimental | Other: Limited Ultrasound ImagingChildren in the limited ultrasound protocol group will receive the same treatment as described for the comprehensive ultrasound group above, except the ultrasound imaging conducted at weeks 2, 5 and 8 will be omitted. Children will still return to clinic at 2, 5, and 8 weeks for clinical examination, which includes the assessment of the Pavlik harness fit and screening for complications. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 0-6 months at time of diagnosis
- Clinical and Ultrasound diagnosis of stable developmental dysplasia of the hip
- Children with dislocated/ unstable DDH will be included once the hip becomes stable
- Treated with Pavlik harness
- Assessed and treated at the SickKids Baby Hip Clinic
Key exclusion criteria (4 listed)
- Underlying neuromuscular disease
- Teratologic hip dysplasia
- Prior treatment at other institutions
- Non-compliance with treatment protocol
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 |
|---|---|---|
| Limited Ultrasound ImagingUltrasound imaging will not be performed at the 2, 5 and 8 week clinic visits | Other | Limited Ultrasound Group |
| Standard Ultrasound ImagingUltrasound imaging will be performed at all clinic visits | Other | Comprehensive Ultrasound Group |
Primary outcome
Acetabular Index
Time frame: When patient reaches 1 year of age
Acetabular Index will be measured on a supine anteroposterior (AP) radiograph of the pelvis
International Hip Dysplasia Institute Score
Time frame: When patient reaches 1 year of age
The International Hip Dysplasia Institute (IHDI) grade will be measured from a radiograph of the pelvis. The score classifies hips into one of four groups based on the position of the proximal femoral metaphysis in relation to the acetabulum. The scores grade severity from Grade 1 as the mildest type to Grade 4 as the most severe type of hip dislocation.
3 secondary outcomes
Complication Rate
Time frame: Through study completion, an average of two years
Health Care Costs
Time frame: Through study completion, an average of two years
Hospital Appointment Duration
Time frame: Through study completion, an average of two years
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 30 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Developmental Dysplasia of the Hip
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
Active, not recruitingObservational study
Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay
Primary Osteoarthritis, Secondary Osteoarthritis
RecruitingObservational study
Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System
Arthritis (Hip), Hip Dysplasia, Congenital
Not yet recruiting
Improving Neonatal Hip Screening With Artificial Intelligence
Developmental Dysplasia of Hip
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.
Simon P Kelley, PhD, FRCS principal investigator
The Hospital for Sick Children, Toronto, Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limited Ultrasound Imaging and Standard Ultrasound Imaging in people with Developmental Dysplasia of the Hip, run by The Hospital for Sick Children at 1 site in Canada.
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 5 inclusion and 4 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Acetabular Index (time frame: When patient reaches 1 year of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2023.