Global Hip Dysplasia Registry

Congenital Hip Dysplasia Clinical Trial

— GHDR  

Official title:

A Prospective, Global Hip Dysplasia Registry With Follow-up to Skeletal Maturity: An Analysis of Risk Factors, Screening Practices and Treatment Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117685
• Other study ID #: H16-01794
• Status: Recruiting
• Start date: September 1, 2016
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2023
• Source: University of British Columbia
• Contact: Emily K Schaeffer, PhD
• Phone: 6048752359
• Email: emily.schaeffer[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 10 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Congenital Dysplasia of the Hip
• Congenital Hip Dislocation
• Congenital Hip Displacement
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Dislocation Of Hip, Congenital
• Dislocation, Congenital Hip
• Displacement, Congenital Hip
• Dysplasia, Congenital Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Displacement, Congenital
• Hip Dysplasia, Congenital, Nonsyndromic
• Hip, Dislocation Of, Congenital
• Hyperplasia

Intervention

Other:
• Observational
All groups will undergo observational data collection. No interventions will be made to patient care.

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Until study completion in 2028
Primary	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.	Until study completion in 2028
Primary	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.	Until study completion in 2028
Primary	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.	Until study completion in 2028
Primary	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.	Until study completion in 2028
Primary	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.	Until study completion in 2028
Primary	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.	Until study completion in 2028
Secondary	Development of targeted sub-studies within the registry	Using data from the registry, further targeted DDH sub-studies will be developed.	Until study completion in 2028
Secondary	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.	Until study completion in 2028
Secondary	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.	Until study completion in 2028
Secondary	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.	Until study completion in 2028
Secondary	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.	Until study completion in 2028