NCT06204068

Spica Cast Duration for DDH

A Prospective Analysis of Optimal Spica Cast Duration Following Closed Reduction for Developmental Dysplasia of the Hip (DDH)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 0 Months – 18 Months
• Healthy volunteers: Not accepted

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.

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 casting to those treated with twelve weeks of supplemental casting. The secondary objectives of this study are to determine if a shorter duration of postoperative casting affects family satisfaction and costs compared to the traditional pathway (12 weeks of spica casting). The physician will meet with the patients during the regular standard of care follow-ups every 2-3 weeks to track patient progress. Following 6 weeks of recovery, the control group will have their spica cast replaced in the operating room, with the child anesthetized, by another cast for 6 weeks. The experimental group will have their cast removed in the clinic without anesthesia and will be placed into a full-time brace for 6 weeks. Participants will be instructed to complete the full 12 weeks of the protocols. Only patients who complete the full length of treatment in either group will be considered for the study. The physicians will keep track of patients during visits to ensure the protocols are being followed.

Conditions

• Dysplasia; Hip

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-01-12
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States