Global Hip Dysplasia Registry

NCT ID: NCT04117685

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2028-12-31

Brief 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.

Detailed 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.

Conditions

Hip Dislocation, Congenital; Hip Dysplasia, Congenital, Nonsyndromic; Congenital Dysplasia of the Hip; Congenital Hip Dislocation; Congenital Hip Displacement; Congenital Hip Dysplasia; Dislocation of Hip, Congenital; Dislocation, Congenital Hip; Displacement, Congenital Hip; Dysplasia, Congenital Hip; Hip Displacement, Congenital; Hip, Dislocation Of, Congenital

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm I: Prospective from diagnosis

Patients have been enrolled and followed since diagnosis will be placed into Arm I.

Observational

Intervention Type: OTHER

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

Arm II: Prior treatment at center

Patients who have received previous treatment and will continue to receive treatment at the participating center will be placed into Arm II.

Observational

Intervention Type: OTHER

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

Arm III: Prior treatment at outside center

Patients who have received previous treatment at an outside center but are continuing treatment at a participating center will be placed into Arm III.

Observational

Intervention Type: OTHER

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

Interventions

Observational

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kishore Mulpuri

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kishore Mulpuri, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Emily K Schaeffer, PhD

Role: CONTACT

emily.schaeffer@cw.bc.ca

6048752359

Ashley L Munoz, BSc

Role: CONTACT

ashley.munoz@cw.bc.ca

6048752359

Facility Contacts

Emily K Schaeffer, PhD

Role: primary

emily.schaeffer@cw.bc.ca

6048752359

Ashley L Munoz, BSc

Role: backup

eva.habib@cw.bc.ca

6048752359

Kishore Mulpuri, MSc

Role: backup

Emily K Schaeffer, PhD

Role: backup

Other Identifiers

H16-01794

Identifier Type: -

Identifier Source: org_study_id