Spica Cast Duration for DDH

NCT06204068 | Withdrawn

• 2 other identifiers: 2000035569000
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (1)

• Family Satisfaction/Burden using Pediatric Outcome Questionnaire

  12 weeks

Study Arms (2)

Hip Spica 6 weeks, Brace 6 weeks

EXPERIMENTAL

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.

Device: Spica cast; Device: Rhino brace

Hip Spica 12 weeks (Control)

ACTIVE COMPARATOR

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.

Device: Spica cast

Interventions

Spica cast DEVICE

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.

Hip Spica 12 weeks (Control); Hip Spica 6 weeks, Brace 6 weeks

Rhino brace DEVICE

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.

Hip Spica 6 weeks, Brace 6 weeks

Eligibility Criteria

• Age: 0 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Dominick Tuason, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Adrienne Socci, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: May 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)