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Completed

NCT Number: NCT01375218

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

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.

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Key information

Conditions

Hip Dislocation, Congenital Congenital Abnormalities Congenital Deformity of Hip Joint Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OrthoCarolina Research Institute, OrthoCarolina, P.A.

Charlotte, North Carolina, 28209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Ages greater than 2 months
  • Neurological condition
  • Terratological congenital dysplasia of the hip diagnosed by physical exam and standard of care ultrasound
  • Chromosomal abnormality

Treatment and study plan

Pavlik Brace

Other

Pavlik Brace

Plastizote Brace

Other

Plastizote Brace

Primary outcomes

  1. Resolution of instability

    Time frame: 3-4 week interval

    Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage

Secondary outcomes

  1. Resolution of instability

    Time frame: 6 month interval

    Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 17, 2011
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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