Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT04117685

Conditions

Hip Dislocation, Congenital

Hip Dysplasia, Congenital, Nonsyndromic

Congenital Dysplasia of the Hip

Congenital Hip Dislocation

Congenital Hip Displacement

Eligibility Criteria

Sex: All

Age: 0 - 10

Healthy Volunteers: Not accepted

Interventions

Observational

Study Details

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

Study ID

NCT04117685

Start date

Sep 1, 2016

Status verified date

Nov, 2024

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 10

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Arm I: Prospective from diagnosis

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

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.

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.

Interventions

Observational

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

Primary outcome measure

  • Development of a general, prospective DDH registry with follow-up to skeletal maturity [ Time Frame: Until study completion in 2028 ]
  • Identification of variation in DDH screening, diagnosis, and management protocols [ Time Frame: Until study completion in 2028 ]
  • Comparison of brace treatment outcomes within and across diagnostic categories [ Time Frame: Until study completion in 2028 ]
  • Comparison of surgical treatment outcomes within and across diagnostic categories [ Time Frame: Until study completion in 2028 ]
  • Identification of optimal timing of both bracing and surgical treatment [ Time Frame: Until study completion in 2028 ]
  • Identification and characterization of risk factors for treatment complications (i.e., AVN) [ Time Frame: Until study completion in 2028 ]
  • Identification of predictors of the need for hip reconstructive surgery in adolescence [ Time Frame: Until study completion in 2028 ]

Central Contacts and Locations

Central contacts

Emily K Schaeffer, PhD

6048752359emily.schaeffer@cw.bc.ca

Ashley L Munoz, BSc

6048752359ashley.munoz@cw.bc.ca

Locations

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Emily K Schaeffer, PhD

6048752359emily.schaeffer@cw.bc.ca

Ashley L Munoz, BSc

6048752359eva.habib@cw.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Nov 18, 2024

Last verified

Nov, 2024

Keywords

  • hip dysplasia
  • ddh
  • developmental dysplasia of the hip
  • congenital hip dysplasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-11-18.