Upasani 2016.
Study characteristics | ||
Methods |
Design: prospective cohort Unit of randomization and analysis: hips |
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Participants |
Location/Setting: multi (7 institutions); North America, Europe and Australia Sample size: 202 babies (258 hips, 56 bilateral); 159 babies analyzed (204 hips, 45 bilateral) Number of withdrawals/dropouts: 43 babies and 54 hips lost to follow‐up Sex: 44 boys, 160 girls Mean age: 39 (SD 36) days (range 0‐163 days) Graf: < IV = 121, IV = 80 Inclusion criteria: less that 6 months old; new dislocation at rest on US or X‐ray (US femoral head < 30% covered on the coronal view OR International Hip Dysplasia Institute grade III or grade IV on radiographs) Exclusion criteria: enrolled in the study but their family refused treatment; if the dislocation was associated with a syndrome or other congenital hip abnormality; if they had a milder form of DDH, such as a subluxable or dysplastic hip with no dislocation; or if they had received previous treatment for DDH |
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Interventions |
Intervention (sample size): static — brace treatment, with Denis Browne, Von Rosen, Plastazote (n = 14 hips) Control (sample size): dynamic — Pavlik harness (n = 190 hips) |
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Outcomes |
Primary outcome(s): successful treatment Secondary outcome(s): measurement of acetabular index, as determined by radiographs (angle); need for operative intervention to achieve reduction; avascular necrosis (include grading system); femoral nerve palsy Timing of outcome assessment: followed up for minimum 18 months |
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Notes |
Study start date: not stated Study end date: not stated Funding source: not stated, but supported by International Hip Dysplasia Institute (hipdysplasia.org) Conflicts of interest: "REDCap database coordination, maintenance, and support was provided by the International Hip Dysplasia Institute (http://hipdysplasia.org). One or more of the authors checked “yes” to indicate that the author had a relevant financial relationship in the biomedical arena outside the submitted work and “yes” to indicate that the author had other relationships or activities that could be perceived to influence, or have the potential to influence, what was written in this work." Comment(s): none |