Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants

OrthoCarolina Research Institute, Inc.

Status and phase: Completed; Phase 4

Conditions: Hip Dislocation, Congenital; Congenital Deformity of Hip Joint

Treatments: Other: Pavlik Brace; Other: Plastizote Brace

Study type: Interventional

Funder types: Other

Identifiers

NCT01375218

041101A

Details and patient eligibility

About

The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.

Enrollment: 30 patients

Sex: All

Ages: Under 2 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 0-2 months of age
2. Nonterratological developmental dysplasia of the hip diagnosed by physical exam and standard of care ultrasound

Exclusion criteria

1. Ages greater than 2 months
2. Neurological condition
3. Terratological congenital dysplasia of the hip diagnosed by physical exam and standard of care ultrasound
4. Chromosomal abnormality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Plastizote Brace

Active Comparator group

Treatment:

Other: Plastizote Brace

Pavlik Brace

Active Comparator group

Treatment:

Other: Pavlik Brace