NCT06204068|Withdrawn
Study Stopped
Lack of enrolment
Spica Cast Duration for DDH
A Prospective Analysis of Optimal Spica Cast Duration Following Closed Reduction for Developmental Dysplasia of the Hip (DDH)
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Lack of enrolment
A Prospective Analysis of Optimal Spica Cast Duration Following Closed Reduction for Developmental Dysplasia of the Hip (DDH)
Sponsor study identifier
Secondary identifiers
OTHER · CTGTY
interventional
0
1 country
1
Study Start
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 treating DDH, and potentially more effective than hip braces alone, other research shows that the outcomes from braces are equivalent to those of spica casts with the added advantage of greater patient satisfaction and less burden on families. Therefore, the 12-week experimental protocol in the study, with the first 6 weeks involving the spica cast and the second 6 weeks the hip brace, was designed to determine if both treatment methods can be combined for an optimal patient experience.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2024
Actual (reported)January 12, 2024
Actual (reported)May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Re-Dislocation Rate
The incidence of DDH re-occurrence in patients over the 12 week course of the casting or bracing for early re-dislocation rate. This will be the main quantitative value that directly measures the effectiveness of the protocols on maintaining the results of the closed reduction surgery.
up to 12 weeks
Patient Satisfaction Scores using Pediatric Outcome Questionnaire
Pediatric Outcome Questionnaire - 86 questions, item scores are summed for a total score. Total score range from 0-100, Higher score means higher satisfaction.
6 weeks and 12 weeks
Complications Rate
The incidence of any complications that occur over the 12 week course.
up to 12 weeks
Hospital Re-Admission Rate
Number of participants re-admitted to the hospital
up to 12 weeks
Mean Time to Hospital Re-Admission
Mean Time to Hospital Re-Admission in days
up to 12 weeks
Family Satisfaction/Burden using Pediatric Outcome Questionnaire
12 weeks
The experimental group will be placed in a hip spica cast for a total of 6 weeks, then will transition to a brace for 6 weeks.
The control group will be placed in a hip spica cast for a total of 12 weeks with a change of spica cast, under anesthesia, at the 6-week mark. This treatment is the accepted standard of care for children who undergo closed reduction of a developmentally dysplastic and dislocated hip.
Spica cast is a cast that is placed while the child is sedated or under anesthesia, covering lower part of belly, waist, and both legs made up of fiberglass, also keeps legs in abduction and flexion. This device will be used as intended and is commonly used for the treatment of DDH.
Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
Dominick Tuason, MD
Yale University
Adrienne Socci, MD
Yale University
0 participants (actual enrollment reported by the registry).
First Submitted
January 2, 2024
First Posted
January 12, 2024
Study Start
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies
Hip abduction brace will be used, which keeps the legs abducted and flexed. A hip brace is a special type of brace that is designed to hold the hips in a flexed and abducted position. This position allows the hip joint to develop properly while it heals. This device will be used as intended and is commonly used for the treatment of DDH.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 24, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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