Congenital Hip Dysplasia Clinical Trial
— GHDROfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | British Columbia Children's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
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 |
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