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

Hip Dislocation, Congenital Clinical Trial

Official title:

Efficacy and Satisfaction Comparing Two Braces in the Treatment of DDH in Infants: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375218
• Other study ID #: 041101A
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2011
• Last updated: January 16, 2015
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Deformity of Hip Joint
• Dislocations
• Hip Dislocation
• Hip Dislocation, Congenital

Intervention

Other:
• Pavlik Brace
Pavlik Brace
• Plastizote Brace
Plastizote Brace

Locations

Country	Name	City	State
United States	OrthoCarolina Research Institute, OrthoCarolina, P.A.	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of instability	Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage	3-4 week interval	No
Secondary	Resolution of instability	Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage	6 month interval	No