Status:
WITHDRAWN
Spica Cast Duration for DDH
Lead Sponsor:
Yale University
Conditions:
Dysplasia; Hip
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
This study looks at treatment for developmental dysplasia of the hip (DDH), a condition where there is abnormal development of a child's hip joint. While spica casts are shown to very effective in tre...
Detailed Description
The primary objective of this study is to compare the clinical outcomes of patients who undergo closed reduction of a developmentally dysplastic hip and are treated with six weeks of supplemental cast...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with DDH
- Require closed reduction of the hip and hip spica casting
- between 6-18 months old
- Alpha angle \<60 degrees, beta angle \>55 degrees
- i. Alpha angle is an angle created by lines along bony acetabulum and the ilium, normal is \>60 degrees
- ii. Beta angle is an angle created by lines along the labrum and ilium, normal is \<55 degrees
- c.Have either failed Pavlik harness or have dislocated hip on imaging
Exclusion
- Patients over the age of 18 months
- Patients with DDH who do not require closed reduction surgery
- Patients with DDH who are initially consented for closed reduction surgery but their intraoperative findings necessitate conversion to open surgery
- Families that do not want to participate in the study
- Patients with dysplasia that need open reduction
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06204068
Start Date
May 1 2025
End Date
January 1 2026
Last Update
July 24 2025
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520