Kim 2019.
| Study characteristics | ||
| Methods |
Design: prospective longitudinal cohort Unit of randomization: hips |
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| Participants |
Location/Setting: clinics of eight staff paediatric orthopaedic surgeons in America (not explicitly stated) Sample size: 80 (107 hips) Number of withdrawals/dropouts: two babies were initially observed and then later treated with a Pavlik harness when they were found to have a persistent ultrasonic dysplasia. Twenty‐seven hips were in the observed group and 44 hips in the Pavlik harness group at 2 year follow‐up (51 babies). Sex: 71 girls, 9 boys Mean age: 3.4 (SD 2.6) weeks (range 2.6 to 11.4 weeks) Graf: not reported Inclusion criteria: < 12 weeks at presentation, with at least 3 or more months of follow‐up; normal hip examination; ultrasonic hip dysplasia, defined as having an alpha angle between 40 to 55 degrees and FHC between 10% to 50% Exclusion criteria: babies with underlying syndromes, teratologic abnormalities, or who received previous treatment for DDH |
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| Interventions |
Intervention (sample size): Pavlik harness (n = 65 hips) Control (sample size): surveillance (n = 42 hips) |
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| Outcomes |
Primary outcome(s): acetabular dysplasia, assessed using a standard anteroposterior pelvis radiograph Secondary outcome(s): need for operative intervention Timing of outcome assessment: 2 years |
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| Notes |
Study start date: 2008 Study end date: 2013 Funding source: not stated Conflicts of interest: "Dr. Kim or an immediate family member has received research or institutional support from Medivir and has received non income support (such as equipment or services), commercially derived honoraria, or other non–research‐related funding (such as paid travel) from 3D Matrix and Genentech. Dr. Sucato or an immediate family member has received royalties from Globus Medical and serves as a board member, owner, officer, or committee member of the Pediatric Orthopaedic Society of North America. None of the following authors or any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this article: Ms. Beckwith, Dr. De La Rocha, Ms. Zepeda, and Dr. Jo." Comment(s)
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