Global Hip Dysplasia Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-10
SponsorUniversity of British Columbia

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    All groups will undergo observational data collection. No interventions will be made to patient care.

Treatment groups

5,000 Participants
are divided into 3 treatment groups
Group A: Arm I: Prospective from diagnosis1 intervention
Group B: Arm II: Prior treatment at center1 intervention
Group C: Arm III: Prior treatment at outside center1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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