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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Limited Ultrasound Imaging | Other | Ultrasound imaging will not be performed at the 2, 5 and 8 week clinic visits |
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| Measure | Description | Time Frame |
|---|---|---|
| Acetabular Index | Acetabular Index will be measured on a supine anteroposterior (AP) radiograph of the pelvis | 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. | When patient reaches 1 year of age |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | The frequency of complications between the treatment groups will be compared | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon P Kelley, PhD, FRCS | The Hospital for Sick Children, Toronto, Ontario, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5V 1X8 | Canada |
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| ID | Term |
|---|---|
| D000082602 | Developmental Dysplasia of the Hip |
| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Standard Ultrasound Imaging | Other | Ultrasound imaging will be performed at all clinic visits |
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| 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 | Through study completion, an average of two years |
| D009139 |
| Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |