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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01375218
• Date of registration: 15/06/2011
• Primary sponsor: OrthoCarolina Research Institute, Inc.
• Public title: Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants
• Scientific title: Efficacy and Satisfaction Comparing Two Braces in the Treatment of DDH in Infants: A Randomized Clinical Trial
• Date of first enrolment: June 2011
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01375218
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Susan M Odum, M.Ed

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: 2 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Congenital Deformity of Hip Joint

Hip Dislocation, Congenital

Intervention(s)

Other: Pavlik Brace

Other: Plastizote Brace

Primary Outcome(s)

Resolution of instability [Time Frame: 3-4 week interval]

Secondary Outcome(s)

Resolution of instability [Time Frame: 6 month interval]

Secondary ID(s)

041101A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors