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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05869851
Other study ID # H20-03750
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date September 2028

Study information

Verified date April 2024
Source University of British Columbia
Contact Emily Schaeffer, PhD
Phone 604-875-2359
Email emily.schaeffer@cw.bc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Developmental dysplasia of the hip (DDH) is the most common childhood hip condition. When caught early, bracing is the most frequently used treatment; however, the brace can disrupt important mother-baby bonding time in the newborn period and present challenges to daily living. In babies with mild DDH, some studies have suggested that their hips may improve naturally as they grow and develop. This study will look at whether careful monitoring can be just as good as bracing for babies diagnosed with mild DDH less than 3 months of age, potentially avoiding unnecessary treatment. This will be the first study to look at this question with babies being treated at different hospitals in seven different countries, so the results will make an impact on children and families worldwide.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pavlik Harness
The Pavlik harness is an abduction brace used for treatment of hip dysplasia in infants. It keeps the hips in proper alignment to allow for appropriate growth and development of the joint.

Locations

Country Name City State
Canada BC Children's Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Centre Edge Angle To be assessed for participants who elect to take part in the Global Hip Dysplasia Registry and have available data. Measured on x-ray, it is the angle formed between the vertical axis of the pelvis and a line from the centre of the femoral head to the lateral edge of the acetabulum. 5 years
Primary Acetabular Index A measure of the steepness of the acetabular roof assessed on radiograph. 2 years
Secondary Alpha Angle This angle is measured via ultrasound and refers to the angle between the acetabular roof and vertical cortex of the ilium. 6 weeks
Secondary Beta Angle This angle is measured via ultrasound and refers to the angle formed between the vertical cortex of the ilium and the triangular labral fibrocartilage (echogenic triangle). 6 weeks
Secondary Percent Femoral Head Coverage Measured via ultrasound and assesses the percentage of the femoral epiphysis covered by the acetabular roof. 6 weeks
Secondary Number of Participants that Experienced Complications Including development of femoral nerve palsy or avascular necrosis, progression of hip dysplasia, and need for further treatment. 2 years
Secondary Parent/Guardian Perception Questionnaire A survey assessing parent/guardian perceptions of caring for and bonding with their child. Each question is scored on a 7-point likert scale from 3 (strongly agree) to -3 (strongly disagree) with total scores ranging from 33 to -33. 6 weeks
Secondary EuroQoL-5D A survey assessing parent quality of life. Only the VAS portion of the questionnaire will be asked at each visit. The VAS is scored from 0 to 100 with higher scores indicating better health. 6 weeks, 1 year, 2 years
Secondary Parent/Guardian Satisfaction Assessed using a VAS scored from 0 to 100 with higher scores indicating higher satisfaction. 6 weeks, 1 year, 2 years
Secondary Healthcare Resource Use Questionnaire Parent/guardian reported questionnaire to collect information about visits to health care professionals, imaging, medication use, additional treatments related to the diagnosis of DDH, and out of pocket costs. 6 weeks, 6 months, 1 year, 18 months, 2 years (Canadian centres only)
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