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

Phase 4

Completed

• Conditions: Congenital Deformity of Hip Joint; Hip Dislocation, Congenital
• Interventions: Other: Plastizote Brace; Other: Pavlik Brace

• Registration Number: NCT01375218
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-17
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-12
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plastizote Brace	Plastizote Brace	-
Pavlik Brace	Pavlik Brace	-

Primary Outcome Measures

Name	Time	Method
Resolution of instability	3-4 week interval	Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage

Secondary Outcome Measures

Name	Time	Method
Resolution of instability	6 month interval	Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage

Trial Locations

Locations (1)

OrthoCarolina Research Institute, OrthoCarolina, P.A.; 🇺🇸 Charlotte, North Carolina, United States