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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01375218
First received: June 15, 2011
Last updated: June 26, 2014
Last verified: December 2013

June 15, 2011
June 26, 2014
June 2011
June 2013   (final data collection date for primary outcome measure)
Resolution of instability [ Time Frame: 3-4 week interval ] [ Designated as safety issue: No ]
Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage
Same as current
Complete list of historical versions of study NCT01375218 on ClinicalTrials.gov Archive Site
Resolution of instability [ Time Frame: 6 month interval ] [ Designated as safety issue: No ]
Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage
Same as current
Not Provided
Not Provided
 
Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants
Efficacy and Satisfaction Comparing Two Braces in the Treatment of DDH in Infants: A Randomized Clinical Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hip Dislocation, Congenital
  • Congenital Deformity of Hip Joint
  • Other: Pavlik Brace
    Pavlik Brace
  • Other: Plastizote Brace
    Plastizote Brace
  • Active Comparator: Plastizote Brace
    Intervention: Other: Plastizote Brace
  • Active Comparator: Pavlik Brace
    Intervention: Other: Pavlik Brace
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
up to 2 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01375218
041101A
Yes
OrthoCarolina Research Institute, Inc.
OrthoCarolina Research Institute, Inc.
Not Provided
Not Provided
OrthoCarolina Research Institute, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP