Spica Cast Duration for DDH

Dysplasia; Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06204068
• Other study ID #: 2000035569
• Secondary ID: 000
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Dominick Tuason, MD
• Phone: 2037862579
• Email: dominick.tuason[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 18 Months

Eligibility

Inclusion Criteria:

• 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

1. between 6-18 months old

2. 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 Criteria:

• 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

Related Conditions & MeSH terms

• Dysplasia; Hip

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Complications Rate	The incidence of any complications that occur over the 12 week course.	up to 12 weeks
Primary	Hospital Re-Admission Rate	Number of participants re-admitted to the hospital	up to 12 weeks
Primary	Mean Time to Hospital Re-Admission	Mean Time to Hospital Re-Admission in days	up to 12 weeks
Secondary	Family Satisfaction/Burden 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.	12 weeks