Hip Dislocation, CongenitalGHDRNCT04117685
Global Hip Dysplasia Registry
An observational study of Hip Dislocation, Congenital and Hip Dysplasia, Congenital, Nonsyndromic, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 10 years
- Conditions the study is for
- Hip Dislocation, Congenital, Hip Dysplasia, Congenital, Nonsyndromic, Congenital Dysplasia of the Hip
- What is being tested?
- Observational
- How many people
- 5,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2016to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 10 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
Emily K Schaeffer, PhD, 6048752359, emily.schaeffer@cw.bc.ca
Ashley L Munoz, BSc, 6048752359, eva.habib@cw.bc.ca
About this study
Official 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.
Read the 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
- Being tested
- Observational
- Keywords
- hip dysplasia, ddh, developmental dysplasia of the hip, congenital hip dysplasia
- Medical subject headings
- Hip Dislocation, Congenital, Hip Dislocation, Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
All groups will undergo observational data collection. No interventions will be made to patient care.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Prospective from diagnosis | Patients have been enrolled and followed since diagnosis will be placed into Arm I. Receives: 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. Receives: 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Until study completion in 2028
Secondary outcomes (5)
Development of targeted sub-studies within the registry
Using data from the registry, further targeted DDH sub-studies will be developed.
Measured: 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)
Risk factor screening and monitoring protocols for DDH by a non-inferiority RCT will be assessed and analyzed.
Measured: Until study completion in 2028
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.
Measured: Until study completion in 2028
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.
Measured: Until study completion in 2028
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.
Measured: Until study completion in 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Sep 2016
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Dislocation, CongenitalStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kishore Mulpuri, University of British Columbia
- Investigators
- Kishore Mulpuri, FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117685
- Sponsor's protocol ID
- H16-01794
- Acronym
- GHDR
- Status last verified
- Nov 2024
- First submitted
- 2 Oct 2019
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Global Hip Dysplasia Registry with Follow-up to Skeletal Maturity: an Analysis of Risk Factors, Screening Practices and Treatment Outcomes
- ClinicalTrials.gov ID
- NCT04117685
- Acronym / sponsor ID
- GHDR / H16-01794
- Conditions
- Hip Dislocation, Congenital, Hip Dysplasia, Congenital, Nonsyndromic, Congenital Dysplasia of the Hip, Congenital Hip Dislocation, Congenital Hip Displacement, Congenital Hip Dysplasia
- Keywords
- hip dysplasia, ddh, developmental dysplasia of the hip, congenital hip dysplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I: Prospective from diagnosis | – | Other: ObservationalPatients have been enrolled and followed since diagnosis will be placed into Arm I. |
| Arm II: Prior treatment at center | – | Other: ObservationalPatients 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 | – | Other: ObservationalPatients who have received previous treatment at an outside center but are continuing treatment at a participating center will be placed into Arm III. |
Who may qualify
- Ages
- 1 minute to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalAll groups will undergo observational data collection. No interventions will be made to patient care. | Other | Arm I: Prospective from diagnosis, Arm II: Prior treatment at center, Arm III: Prior treatment at outside center |
Primary outcome
Development of a general, prospective DDH registry with follow-up to skeletal maturity
Time frame: Until study completion in 2028
Data will be collected from patients with or at risk of DDH to create a registry. Patients will be followed up until skeletal maturity.
Identification of variation in DDH screening, diagnosis, and management protocols
Time frame: Until study completion in 2028
Using data from the registry, variation in DDH screening, diagnosis, and management protocols will be identified.
Comparison of brace treatment outcomes within and across diagnostic categories
Time frame: Until study completion in 2028
Using data from the registry, brace treatment outcomes within and across diagnostic categories will be compared.
Comparison of surgical treatment outcomes within and across diagnostic categories
Time frame: Until study completion in 2028
Using data from the registry, surgical treatment outcomes within and across diagnostic categories will be compared.
Identification of optimal timing of both bracing and surgical treatment
Time frame: Until study completion in 2028
Using data from the registry, optimal timing of both bracing and surgical treatment will be identified.
Identification and characterization of risk factors for treatment complications (i.e., AVN)
Time frame: Until study completion in 2028
Using data from the registry, risk factors for treatment complications (i.e., AVN) will be identified and characterized.
Identification of predictors of the need for hip reconstructive surgery in adolescence
Time frame: Until study completion in 2028
Using data from the registry, predictors of the need for hip reconstructive surgery in adolescence will be identified.
5 secondary outcomes
Development of targeted sub-studies within the registry
Time frame: 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)
Time frame: Until study completion in 2028
A comparison of rigid versus dynamic bracing in early treatment of DDH by RCT
Time frame: Until study completion in 2028
A comparison of observation versus bracing in clinically stable, ultrasonographically dysplastic hips by RCT
Time frame: Until study completion in 2028
An analysis of the impact of brace treatment length after hip stabilization by RCT
Time frame: Until study completion in 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kishore Mulpuri, FRCSC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Dislocation, Congenital and Hip Dysplasia, Congenital, Nonsyndromic, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily K Schaeffer, PhD (6048752359, emily.schaeffer@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a general, prospective DDH registry with follow-up to skeletal maturity (time frame: Until study completion in 2028). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.