Pavlik Harness for Hip Dysplasia
What You Need to Know Before You Apply
What is the purpose of this trial?
Developmental dysplasia of the hip is the most common bone and joint condition in babies. It is usually treated with a harness that holds the hips in a safe position so they can develop normally. After the hip is confirmed to be in the correct position, babies are commonly kept in the harness for up to 12 weeks or more. While effective, wearing a harness for this length of time can be challenging for families. It can make everyday care such as feeding, bathing and dressing more difficult, and add stress during an important time for bonding.
This trial compares two treatment options: 8 versus 12 weeks of harness wear. The 8-week option is being tested because research has shown that most hips appear normal on ultrasound by this point. The main measure of success is whether the hip looks normal on x-ray two years after treatment. Families will also be asked about their experience and treatment-related problems.
If the shorter option is as effective as the longer option, many babies could spend less time in brace, reducing burden without compromising outcomes. Because this trial is embedded in routine care, results can be put into practice quickly and guide care for babies across Ontario and beyond.
Who Is on the Research Team?
Luckshman Bavan
Principal Investigator
The Hospital for Sick Children
Are You a Good Fit for This Trial?
This trial is for babies diagnosed with developmental dysplasia of the hip who are being treated with a Pavlik harness. It includes infants whose hips have been confirmed to be in the correct position after starting treatment.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Pavlik Harness
Trial Overview
The study compares wearing a Pavlik harness for either 8 weeks or 12 weeks to see if shorter treatment works as well as longer treatment. Babies are randomly assigned to one of these two groups, and their hip development is checked over time.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomised to this group will undergo an 8-week post-centring Pavlik harness maturation period. If predefined stopping criteria are not met at 8 weeks, treatment will be extended according to the study protocol. Clinical and imaging assessments will be completed according to the established care pathway.
Participants randomised to this group will undergo the SickKids standard 12-week post-centring Pavlik harness maturation period. If predefined stopping criteria are not met at 12 weeks, treatment will be extended according to the study protocol. Clinical and imaging assessments will be completed according to the established care pathway.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Hospital for Sick Children
Lead Sponsor
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