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. 2022 Oct 10;2022(10):CD012717. doi: 10.1002/14651858.CD012717.pub2

NCT01375218.

Study name Public title: Efficacy and satisfaction comparing two braces in the treatment of developmental dysplasia of the hip (DDH) in infants
Official title: Efficacy and satisfaction comparing two braces in the treatment of DDH in infants: a randomized clinical trial
Methods Phase 4 parallel RCT, open‐label
Participants 30 babies
Inclusion criteria
  1. 0 to 2 months of age

  2. Non‐terratological 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

Interventions
  1. Pavlik brace (n = not reported)

  2. Plastizote brace (n = not reported)

Outcomes Primary outcome
  1. Resolution of instability at 3 to 4‐week interval: measured by negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage


Secondary outcome
  1. Resolution of instability at 6‐month interval: measured by negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage

Starting date June 2011
Contact information Name: OrthoCarolina Research Institute, Inc
Address: OrthoCarolina Research Institute, OrthoCarolina, PA, Charlotte, North Carolina, United States, 28209
Email: not provided
Notes Comment: completed in June 2013. We contacted OrthoCarolina Research Institute for further information but no reply was received.