Global Hip Dysplasia Registry

NCT04117685 | Recruiting DMC

• 1 other identifier: H16-01794
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

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

Keywords

hip dysplasia; ddh; developmental dysplasia of the hip; congenital hip dysplasia

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Development of targeted sub-studies within the registry

  Until study completion in 2028

• Assessment and analysis of risk factor screening and monitoring protocols for DDH by a non-inferiority randomized controlled trial (RCT)

  Until study completion in 2028

• A comparison of rigid versus dynamic bracing in early treatment of DDH by RCT

  Until study completion in 2028

• A comparison of observation versus bracing in clinically stable, ultrasonographically dysplastic hips by RCT

  Until study completion in 2028

• An analysis of the impact of brace treatment length after hip stabilization by RCT

  Until study completion in 2028

Study Arms (3)

Arm I: Prospective from diagnosis

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

Other: Observational

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.

Other: Observational

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.

Other: Observational

Interventions

Observational OTHER

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

Arm I: Prospective from diagnosis; Arm II: Prior treatment at center; Arm III: Prior treatment at outside center

Eligibility Criteria

• Age: 1 Minute - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Hip Dislocation, Congenital; Hip Dislocation; Developmental Dysplasia of the Hip

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Dislocations; Joint Diseases; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Kishore Mulpuri, FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily K Schaeffer, PhD

CONTACT

6048752359; emily.schaeffer@cw.bc.ca

Ashley L Munoz, BSc

CONTACT

6048752359; ashley.munoz@cw.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 7, 2019
• Study Start: September 1, 2016
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)