Congenital Hip Dysplasia Clinical Trial
Official title:
A Prospective, Global Hip Dysplasia Registry With Follow-up to Skeletal Maturity: An Analysis of Risk Factors, Screening Practices and Treatment Outcomes
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01285843 -
Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component
|
N/A | |
Terminated |
NCT00872547 -
Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement
|
Phase 4 | |
Completed |
NCT02162186 -
Clinical and Radiographic Outcomes of the Corin Tri-Fit Total Hip Replacement
|
||
Completed |
NCT00516555 -
EBIS: The Eindhoven Breech Intervention Study
|
N/A | |
Active, not recruiting |
NCT03357445 -
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
|
N/A | |
Active, not recruiting |
NCT03226808 -
Vivacit-E Post-market Follow-up Study
|
N/A | |
Terminated |
NCT00872794 -
A Single Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
|
Phase 4 | |
Active, not recruiting |
NCT03396224 -
Avenir® Cemented Hip Stem - PMCF
|
||
Terminated |
NCT00208351 -
A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement
|
Phase 3 | |
Terminated |
NCT02196818 -
A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup
|
||
Completed |
NCT00872066 -
A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement
|
Phase 4 | |
Completed |
NCT02399007 -
A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China
|
N/A | |
Completed |
NCT00208442 -
A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement
|
Phase 4 | |
Recruiting |
NCT05460715 -
The Medacta Quadra-P Anteverted Study
|
||
Recruiting |
NCT02748408 -
The Medacta International SMS Post-Marketing Surveillance Study
|
||
Terminated |
NCT00873444 -
A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-Metal or a Metal-on-Metal Bearing
|
Phase 4 | |
Terminated |
NCT00208377 -
A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
|
Phase 4 | |
Recruiting |
NCT02783274 -
Actis Total Hip System 2 Year Follow-up
|
N/A | |
Terminated |
NCT01635166 -
Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery
|
Phase 4 | |
Terminated |
NCT00872573 -
A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Total Primary Hip Replacement
|
Phase 4 |