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Observation vs. Bracing for Hip Dysplasia

N/A
Recruiting
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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 1 year, 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 1 year, 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acetabular Index
Secondary study objectives
Alpha Angle
Beta Angle
EuroQoL-5D
+5 more
Other study objectives
Centre Edge Angle

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,484,942 Total Patients Enrolled
3 Trials studying Developmental Dysplasia of the Hip
9,075 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
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

Media Library

Pavlik Harness Clinical Trial Eligibility Overview. Trial Name: NCT05869851 — N/A
Developmental Dysplasia of the Hip Research Study Groups: Brace Treatment, Active Monitoring
Developmental Dysplasia of the Hip Clinical Trial 2023: Pavlik Harness Highlights & Side Effects. Trial Name: NCT05869851 — N/A
Pavlik Harness 2023 Treatment Timeline for Medical Study. Trial Name: NCT05869851 — N/A
~343 spots leftby Sep 2027
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