About this trial
Developmental dysplasia of the hip (DDH) is the most common hip condition affecting infants and children. DDH represents a spectrum of issues affecting the hip joint - a "ball-and-socket" joint. When the femoral head (the "ball) is seated properly in the acetabulum (the "socket"), the hip is stable and can develop normally. However, when the femoral head is not well-seated, the hip can become unstable or dislocate. This instability or dislocation of the femoral head prevents the hip joint from developing normally during infancy and early childhood. If left undetected or untreated, it can lead to debilitating complications later in life.
Development of a comprehensive, prospective international registry for all infants and children with DDH will provide the potential to impact all infants born, not only in British Columbia, but around the world. The purpose of this initiative is to identify best practices and standardize treatment and management strategies in order to optimize clinical and functional outcomes for patients with DDH. This registry includes targeted specific outcomes that will be investigated, in addition to the general collection of data on all patients diagnosed with any form of DDH up to the age of 10 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 0 and 10 years at time of initial diagnosis
Referred for DDH screening due to specific risk factors OR diagnosed with DDH
Diagnosis confirmed with appropriate ultrasonographic or radiographic imaging
Disqualifiers
Known or suspected neuromuscular, collagen, chromosomal or lower extremity congenital anomalies
Teratologic hip dislocation (syndromic-associated dislocations)
Over 10 years of age at initial diagnosis
Received prior treatment for DDH without appropriate imaging or documentation
Trial population
Patients who have been referred to a participating center for DDH risk factors or patients with diagnosed DDH will be included in the registry. Patients will be enrolled during one of their routine clinic appointments at one of the participating centers.
Trial design
Cohort
Prospective
Treatments tested in this trial
Observational
Other interventionAll groups will undergo observational data collection. No interventions will be made to patient care.
Treatment groups
Trial outcomes
Primary outcomes
Development of a general, prospective DDH registry with follow-up to skeletal maturity
Data will be collected from patients with or at risk of DDH to create a registry. Patients will be followed up until skeletal maturity.
Identification of variation in DDH screening, diagnosis, and management protocols
Using data from the registry, variation in DDH screening, diagnosis, and management protocols will be identified.
Comparison of brace treatment outcomes within and across diagnostic categories
Using data from the registry, brace treatment outcomes within and across diagnostic categories will be compared.
Comparison of surgical treatment outcomes within and across diagnostic categories
Using data from the registry, surgical treatment outcomes within and across diagnostic categories will be compared.
Secondary outcomes
Development of targeted sub-studies within the registry
Using data from the registry, further targeted DDH sub-studies will be developed.
Assessment and analysis of risk factor screening and monitoring protocols for DDH by a non-inferiority randomized controlled trial (RCT)
Risk factor screening and monitoring protocols for DDH by a non-inferiority RCT will be assessed and analyzed.
A comparison of rigid versus dynamic bracing in early treatment of DDH by RCT
Rigid versus dynamic bracing in early treatment DDH by RCT will be compared.
A comparison of observation versus bracing in clinically stable, ultrasonographically dysplastic hips by RCT
Observation versus bracing in clinically stable, ultrasonographically dysplastic hips by RCT will be compared.
Sponsors and contacts
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