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Observation vs. Bracing for Hip Dysplasia
N/A
Waitlist Available
Led By Kishore Mulpuri, FRCSC
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 1 year, 2 years
Awards & highlights
Study Summary
This trial will look at whether monitoring mild DDH is as effective as bracing in babies less than 3 months old, potentially avoiding unnecessary treatment. Results will impact children and families worldwide.
Who is the study for?
This trial is for babies under three months old with mild Developmental Dysplasia of the Hip (DDH), which means their hip joints are not formed properly. They must have a specific range of hip angles and coverage on ultrasound exams. Babies with more severe DDH or other health issues that could interfere with the study are not eligible.Check my eligibility
What is being tested?
The study is testing if careful observation is as effective as using a Pavlik Harness, which is a brace used to treat babies with DDH. The comparison will help determine if bracing can be avoided in cases of mild DDH without affecting outcomes.See study design
What are the potential side effects?
While this study does not involve medication, wearing a Pavlik Harness may cause skin irritation, discomfort, or limit movement for the baby. Observation has no physical side effects but carries the risk that DDH might not improve on its own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks, 1 year, 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 1 year, 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acetabular Index
Secondary outcome measures
Alpha Angle
Beta Angle
EuroQoL-5D
+5 moreOther outcome measures
Centre Edge Angle
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Brace TreatmentExperimental Treatment1 Intervention
Patients randomized to the brace treatment group will be treated with a Pavlik harness for a minimum of six weeks.
Group II: Active MonitoringActive Control1 Intervention
Patients randomized to the control group will undergo observation only.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,413 Previous Clinical Trials
2,466,447 Total Patients Enrolled
3 Trials studying Developmental Dysplasia of the Hip
9,075 Patients Enrolled for Developmental Dysplasia of the Hip
Kishore Mulpuri, FRCSCPrincipal InvestigatorUniversity of British Columbia
2 Previous Clinical Trials
7,000 Total Patients Enrolled
1 Trials studying Developmental Dysplasia of the Hip
5,000 Patients Enrolled for Developmental Dysplasia of the Hip
Emily Schaeffer, PhDStudy DirectorUniversity of British Columbia
1 Previous Clinical Trials
4,000 Total Patients Enrolled
1 Trials studying Developmental Dysplasia of the Hip
4,000 Patients Enrolled for Developmental Dysplasia of the Hip
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known muscle, collagen, genetic disorder, or hip abnormality.I have been treated for hip dysplasia before.My baby has hip issues detected on an X-ray but is under 3 months old.
Research Study Groups:
This trial has the following groups:- Group 1: Brace Treatment
- Group 2: Active Monitoring
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being accepted for this investigation at present?
"According to information from clinicaltrials.gov, this medical trial is not currently seeking participants; it was initially posted on September 1st 2023 and last modified on May 19th 2023. Nonetheless, there are still 160 other trials actively recruiting patients at the present moment."
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