Congenital Deformity of Hip Joint, Hip Dislocation, Congenital
Conditions
Brief summary
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.
Interventions
OTHERPavlik Brace
Pavlik Brace
OTHERPlastizote Brace
Plastizote Brace
Sponsors
OrthoCarolina Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of instability | 3-4 week interval | Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of instability | 6 month interval | Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage |
Countries
United States
Outcome results
None listed