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

Gardiner 1990.

Study characteristics
Methods Design: RCT or quasi‐RCT
Unit of randomization: baby
Participants Location/Setting: UK
Sample size: 79
Number of withdrawals/dropouts: none stated
Sex: intervention = 56 girls, 23 boys; control = 54 girls, 25 boys
Mean age: 40 (SD 1.6) weeks
Graf: babies: I = 34, IIa = 50, IIc = 19, III=44, IV = 11; controls: I = 82, IIa = 61, IIc = 6, III = 8, IV = 1
Inclusion criteria: diagnosed within 24 hours of birth; clinically dislocatable hips
Exclusion criteria: clinically dislocated hips (they were splinted)
Interventions Intervention (sample size): splinted immediately, type of splint unclear but follow‐up paper suggests Aberdeen Abduction Splint (n = 41)
Control 1 (sample size): sonographic surveillance group (n = 38). Ultrasound scan repeated at 10 to 14 days in this group. If remained clinically unstable or no sonographic improvement, then splinting was commenced (n = 11) and if improved, then continued without splint for the full 6 weeks (n = 27)
Control group 2 (sample size): matched for sex, first‐born status, fetal presentation, gestational age, and family history of congenital dislocation of the hip in a first‐degree relative (n = 79)
Outcomes Primary outcome(s): hip normal/abnormal
Secondary outcome(s): avascular necrosis; need for operative intervention
Timing of outcome assessment: 6‐8 weeks, 6 months, 1 year
Notes Study start date: 1988
Study end date: 1989
Funding source: financial support from Children Nationwide, Southmead Hospital Research Fund; and the Van Neste Foundation
Conflicts of interest: not stated
Comment(s): babies in the control group were matched but the analysis does not seem to take this into account. “Static hips scans were measured according to Graf’s system, types Ia, Ib, and IIa being classified as normal, and types IIb, IIc, IIIa, IIIb and IV as abnormal. Hips that showed dynamic instability were regarded as abnormal even if the static sonographic morphology appeared normal”. Classified according to Graf. Alpha angles not mentioned (but are integral to Graf)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Judgement comment: babies were randomized by alternate allocation to splinting or surveillance. No information was given on the method used.
Allocation concealment (selection bias) Unclear risk Judgement comment: not stated
Blinding of participants and personnel (performance bias)
All outcomes High risk Judgement comment: caring physician and baby could not be blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Judgement comment: those assessing outcomes were blinded.
Incomplete outcome data (attrition bias)
All outcomes High risk Judgement comment: no causal analysis performed to account for treatment switching, which may lead to bias
Selective reporting (reporting bias) Unclear risk Judgement comment: no protocol/trial registry information available to compare pre‐specified outcomes with reported outcomes. The three outcomes mentioned in the methods section were fully reported.