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

This study is currently recruiting participants.
Verified January 2012 by OrthoCarolina Research Institute, Inc.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01375218
First received: June 15, 2011
Last updated: June 6, 2013
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hip Dislocation, Congenital
Congenital Deformity of Hip Joint
 Other: Pavlik Brace
Other: Plastizote Brace
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Satisfaction Comparing Two Braces in the Treatment of DDH in Infants: A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plastizote Brace Other: Plastizote Brace
Plastizote Brace
Active Comparator: Pavlik Brace Other: Pavlik Brace
Pavlik Brace

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375218

Locations
United States, North Carolina
OrthoCarolina Research Institute, OrthoCarolina, P.A. Recruiting
Charlotte, North Carolina, United States, 28209
Contact: Susan M Odum, M.Ed     704-323-2265     susan.odum@orthocarolina.com    
Contact: Christi Cadd, MBA     704-323-2260     christi.cadd@orthocarolina.com    
Principal Investigator: Virginia Casey, MD            
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
  More Information

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01375218     History of Changes
Other Study ID Numbers: 041101A
Study First Received: June 15, 2011
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Congenital Abnormalities
Dislocations
Hip Dislocation
Hip Dislocation, Congenital
Wounds and Injuries
 Hip Injuries
Joint Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities

ClinicalTrials.gov processed this record on June 17, 2013