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Spica Cast Duration for DDH

NCT06204068 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-07-24

No results posted yet for this study

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 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.

Conditions

  • Dysplasia; Hip

Interventions

DEVICE

Spica cast

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.

DEVICE

Rhino brace

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.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Dominick Tuason, MD · Yale University

  • Adrienne Socci, MD · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06204068 on ClinicalTrials.gov