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Assessing a Limited Ultrasound Protocol in DDH

A Non-Inferiority Trial Assessing a Limited Ultrasound Protocol in the Treatment of Developmental Dysplasia of the Hip

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03608475
Enrollment
100
Registered
2018-08-01
Start date
2018-07-27
Completion date
2022-05-10
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Dysplasia of the Hip

Brief 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. 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.

Interventions

OTHERLimited Ultrasound Imaging

Ultrasound imaging will not be performed at the 2, 5 and 8 week clinic visits

OTHERStandard Ultrasound Imaging

Ultrasound imaging will be performed at all clinic visits

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Underlying neuromuscular disease * Teratologic hip dysplasia * Prior treatment at other institutions * Non-compliance with treatment protocol

Design outcomes

Primary

MeasureTime frameDescription
Acetabular IndexWhen patient reaches 1 year of ageAcetabular Index will be measured on a supine anteroposterior (AP) radiograph of the pelvis
International Hip Dysplasia Institute ScoreWhen patient reaches 1 year of ageThe 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.

Secondary

MeasureTime frameDescription
Complication RateThrough study completion, an average of two yearsThe frequency of complications between the treatment groups will be compared
Health Care CostsThrough study completion, an average of two yearsThe difference in cost between the two treatment arms will be the cost of 3 diagnostic ultrasounds
Hospital Appointment DurationThrough study completion, an average of two yearsCalculating time between registering at Ultrasound and registering at the Orthopaedic clinic will provide a measurement of time savings in the limited ultrasound protocol group

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026