Developmental Dysplasia of the Hip: Observation vs. Bracing

Comparison of Brace to Observation in Stable, Radiological Developmental Dysplasia of the Hip: A Multi-centre, International Randomized Controlled Non-inferiority Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Dysplasia; Developmental Dysplasia of the Hip; Hip Dysplasia, Congenital; Hip Dysplasia, Developmental
• Intervention / Treatment: Other: Pavlik Harness

Detailed Description

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:

1. Determine whether observation is non-inferior to bracing for infants with radiological dysplasia
2. Provide a strong recommendation for management of this subset of DDH patients
3. Compare findings to those of the Netherlands trial, which is being carried out in older patients (10-16 weeks at diagnosis)

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.

• Study Type: Interventional
• Enrollment (Estimated): 514
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Schaeffer, PhD; Phone Number: 604-875-2359; Email: emily.schaeffer@cw.bc.ca
• Study Contact Backup: Name: Bryn Zomar, PhD; Phone Number: 604-875-2359; Email: bryn.zomar@cw.bc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H3N1
      • BC Children's Hospital
      • Contact: Emily Schaeffer, PhD; Phone Number: 604-875-2359; Email: emily.schaeffer@cw.bc.ca
      • Principal Investigator: Kishore Mulpuri, FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients presenting with radiological dysplasia of a clinically stable hip under three months (12 weeks) of age
• Radiological dysplasia will be defined as a centred hip with an alpha angle between 43 and 60 degrees and a percent coverage of the femoral head (FHC) greater than 35%, as measured on ultrasound exam

Exclusion Criteria:

• Patients presenting with radiological dysplasia older than three months (12 weeks) of age
• Patients presenting with clinical hip instability (Ortolani or Barlow positive)
• Patients with known or suspected neuromuscular, collagen, chromosomal or lower-extremity congenital abnormalities or syndromic-associated hip abnormalities
• Patients who received prior treatment (i.e. Pavlik harness) for DDH

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brace Treatment; Patients randomized to the brace treatment group will be treated with a Pavlik harness for a minimum of six weeks.	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.
No Intervention: Active Monitoring; Patients randomized to the control group will undergo observation only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acetabular Index	A measure of the steepness of the acetabular roof assessed on radiograph.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Percent Femoral Head Coverage	Measured via ultrasound and assesses the percentage of the femoral epiphysis covered by the acetabular roof.	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.	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.	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.	6 weeks, 1 year, 2 years
Parent/Guardian Satisfaction	Assessed using a VAS scored from 0 to 100 with higher scores indicating higher satisfaction.	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.	6 weeks, 6 months, 1 year, 18 months, 2 years (Canadian centres only)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Study Director: Emily Schaeffer, PhD, University of British Columbia; Principal Investigator: Kishore Mulpuri, FRCSC, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Hyperplasia; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: H20-03750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No