An observational study in Hip Dislocation, Congenital, Hip Dysplasia, Congenital, Nonsyndromic and Congenital Dysplasia of the Hip, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged 1 Minute to 10 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by University of British Columbia · Observational
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.
DDH is the most common pediatric hip condition, with 1-3% of all newborns diagnosed at birth. However, the true incidence of DDH is difficult to quantify due to significant variations in diagnostic criteria, terminology, screening and monitoring procedures, as well as ethnic and cultural differences. The spectrum of DDH encompasses mild dysplasia or instability of a reduced hip, to a completely dislocated, irreducible hip. If left undetected or untreated, it can lead to debilitating complications later in life. Much of the evidence existing to date in the DDH literature is from retrospective and/or single-centre studies, and the spectral nature of the condition has resulted in inconsistent or ill-defined terminology to classify patients in regard to diagnosis and laterality. Consequently, the patient population is often not clearly defined or reported, making it difficult to compare or combine different study results in order to produce strong evidence to guide treatment and management. This issue was highlighted in the updated clinical practice guidelines released in partnership between the American Academy of Orthopaedic Surgery (AAOS) and the Pediatric Orthopaedic Society of North America (POSNA) in 2014. Of the nine recommendations made, only two were of moderate strength, while the other seven were of low strength.
Discrepancies begin with DDH screening practices. Clinical examination for hip instability is a universal standard practice; however, not all cases are detectable by this method, leading to potential missed diagnoses or late-presentations that are more difficult to treat. Beyond the clinical exam, screening, management and treatment practices are highly variable across surgeons, centres and countries. Some countries, particularly those in Europe, employ universal ultrasound screening, while others use selective ultrasound screening as a supplement to the clinical exam for infants with specific risk factors. Defined risk factors that have currently been deemed to warrant further screening and monitoring include breech presentation, family history of DDH or a clinical history of hip instability. Regardless of screening program, missed or late-presentations still occur, warranting further investigation. Further variability is introduced with primary treatment and management. Bracing is the most common first-line treatment, particularly in younger patients or patients with unstable or reducible hips. Surgical treatment (closed or open reduction) is more often used as first-line treatment in older patients, or patients with more severe dislocations. However, significant variation is seen in practice patterns, complication rates and treatment success with each of these methods, and identification and analysis of prognostic factors have been lacking methodological rigor. Development of a comprehensive, prospective registry will provide a unique and unprecedented platform for examining numerous aspects of the full DDH spectrum, including long-term treatment outcomes and risk factors.
57 studies on the registry are indexed under Hip Dislocation, Congenital; 7 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 175 across 18 observational studies indexed under Hip Dislocation, Congenital.
Browse Hip Dislocation, Congenital 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.
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.
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 have been enrolled and followed since diagnosis will be placed into Arm I.
Other: Observational
Patients who have received previous treatment and will continue to receive treatment at the participating center will be placed into Arm II.
Other: Observational
Patients who have received previous treatment at an outside center but are continuing treatment at a participating center will be placed into Arm III.
Other: Observational
All groups will undergo observational data collection. No interventions will be made to patient care.
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.
Time frame: Until study completion in 2028
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.
Time frame: Until study completion in 2028
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.
Time frame: Until study completion in 2028
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.
Time frame: Until study completion in 2028
Identification of optimal timing of both bracing and surgical treatment
Using data from the registry, optimal timing of both bracing and surgical treatment will be identified.
Time frame: Until study completion in 2028
Identification and characterization of risk factors for treatment complications (i.e., AVN)
Using data from the registry, risk factors for treatment complications (i.e., AVN) will be identified and characterized.
Time frame: Until study completion in 2028
Identification of predictors of the need for hip reconstructive surgery in adolescence
Using data from the registry, predictors of the need for hip reconstructive surgery in adolescence will be identified.
Time frame: Until study completion in 2028
Development of targeted sub-studies within the registry
Using data from the registry, further targeted DDH sub-studies will be developed.
Time frame: Until study completion in 2028
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.
Time frame: Until study completion in 2028
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.
Time frame: Until study completion in 2028
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.
Time frame: Until study completion in 2028
An analysis of the impact of brace treatment length after hip stabilization by RCT
The impact of brace treatment length after hip stabilization by RCT will be analyzed.
Time frame: Until study completion in 2028
Plan to share: No
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Started Sep 2016 (actual). Primary completion is estimated for Dec 2028, 147 months after the start.
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