Spica Cast Duration for DDH

Yale University

Status: Begins enrollment this month

Conditions: Dysplasia; Hip

Treatments: Device: Spica cast; Device: Rhino brace

Study type: Interventional

Funder types: Other

Identifiers

NCT06204068

2000035569

000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: Under 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Hip Spica 6 weeks, Brace 6 weeks

Experimental group

Description:

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.

Treatment:

Device: Rhino brace

Device: Spica cast

Hip Spica 12 weeks (Control)

Active Comparator group

Description:

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.

Treatment:

Device: Spica cast