An interventional study of Pavlik Harness in Developmental Dysplasia of the Hip, Hip Dysplasia and Hip Dysplasia, Congenital, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged Up to 12 Weeks. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
Early detection of developmental dysplasia of the hip (DDH) is critical to optimize outcomes and minimize long-term disability and impact on quality of life for the child and family. The burden of disease is significant, with a DDH diagnosis in 15-20/1000 live births. Even when treated, DDH is a leading cause of early hip replacement or development of osteoarthritis in young adults, with DDH reportedly accounting for 10-92% of all hip replacements. Consideration must also be given, however, to potential overtreatment of infants, particularly in more mild cases of hip instability or radiological dysplasia. The hip joint is immature during infancy, and many cases of mild-to-moderate DDH can spontaneously resolve as the hip joint matures through development. Brace treatment for approximately six weeks is common to address this radiological dysplasia; however, it is unclear whether this approach provides significant benefit above careful observation by ultrasound. While a conservative, less costly approach, brace treatment is not without potential complications and drawbacks. There are still substantial healthcare costs and resources associated with brace treatment, but there is potentially an under-recognized psychosocial cost in regard to preventing or disrupting mother-infant bonding in the newborn period. Coping with the difficulties of brace treatment can be stressful for families, particularly mothers of newborns, but the ultimate psychosocial impact has been under-researched to date. There is evidence to suggest that events occurring during establishment of breastfeeding may impact the mother's ability to breastfeed. The UK Hip Trial (2005) also found that maternal anxiety and worries about their infant's hip were increased with early brace treatment, but were not elevated by ultrasound monitoring in isolation. Further, bracing can present challenges to daily family life, including dressing, mobility, and the need for specialized furniture, car seats and other equipment. If observation alone is non-inferior to bracing for radiological dysplasia, unnecessary treatment may be avoided, potentially decreasing both the psychosocial impact of disrupted mother-infant bonding and needed healthcare resources and costs.
The investigators propose to utilize the existing collaborations and infrastructure of the Global Hip Dysplasia Registry (GHDR) and leverage their collaboration with a group in the Netherlands performing a similar Treatment with Active Monitoring (TRAM) trial to determine whether observation alone is sufficient for infants with clinically stable radiologically abnormal hips. Specifically, the investigators aim to:
This study will utilize the established infrastructure of the GHDR. GHDR was established in 2016, aimed at collecting longitudinal data on infants and children across the entire DDH spectrum. This specific trial will function as a targeted sub-study within the more extensive registry, and is a multi-centre, international prospective randomized non-inferiority trial designed to evaluate the necessity to treat infants with radiological hip dysplasia. In total, 14 of the centres currently contributing data to GHDR have agreed to participate and randomize eligible patients.
60 studies on the registry are indexed under Developmental Dysplasia of the Hip; 18 are open to participants now.
This study's planned enrollment of 514 is above the median of 59 across 38 interventional studies indexed under Developmental Dysplasia of the Hip.
Browse Developmental Dysplasia of the Hip studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients randomized to the brace treatment group will be treated with a Pavlik harness for a minimum of six weeks.
Other: Pavlik Harness
Patients randomized to the control group will undergo observation only.
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.
Acetabular Index
A measure of the steepness of the acetabular roof assessed on radiograph.
Time frame: 2 years
Alpha Angle
This angle is measured via ultrasound and refers to the angle between the acetabular roof and vertical cortex of the ilium.
Time frame: 6 weeks
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).
Time frame: 6 weeks
Percent Femoral Head Coverage
Measured via ultrasound and assesses the percentage of the femoral epiphysis covered by the acetabular roof.
Time frame: 6 weeks
Number of Participants that Experienced Complications
Including development of femoral nerve palsy or avascular necrosis, progression of hip dysplasia, and need for further treatment.
Time frame: 2 years
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks, 1 year, 2 years
Parent/Guardian Satisfaction
Assessed using a VAS scored from 0 to 100 with higher scores indicating higher satisfaction.
Time frame: 6 weeks, 1 year, 2 years
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.
Time frame: 6 weeks, 6 months, 1 year, 18 months, 2 years (Canadian centres only)
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.
Time frame: 5 years
Plan to share: No — While we will not make individual participant data available for this study, we do intend to disseminate study results to participants, researchers and the broader public. Our team works closely with patient partners, healthcare personnel, our collaborators and the broader medical/scientific community to determine appropriate ways to disseminate study results. We intend to prepare plain language summaries and visual/video abstracts of study results, which will be emailed to participants (those whom provided consent for email contact). These visual abstracts will also be posted to our lab's social media accounts, as well as that of our supporter, the I'm a HIPpy Foundation, who works closely with our patient and family community.
Started Apr 2024 (actual). Primary completion is estimated for Sep 2027, 41 months after the start.
Of 20 interventional studies with no phase under Developmental Dysplasia of the Hip, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 41 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Developmental Dysplasia of the Hip →
University of British Columbia →