Hui 2014.
Study characteristics | ||
Methods | RCT. Prospective 2‐arm, parallel‐group design Participants were randomised (not feet) |
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Participants | 30 participants (44 feet) who presented to a regional tertiary‐level children's hospital Inclusion criteria: diagnosis of idiopathic CTEV Exclusion criteria: children with non‐idiopathic cause of CTEV ( e.g. arthrogryposis), children previously treated for CTEV, positional deformity PARTICIPANT CHARACTRISTICS Age mean (range): SRF (semi‐rigid fibreglass) group 2 weeks (1 to 11.7); plaster of Paris group 2.3 weeks (0.7 to 5.7) Plaster of Paris casting group Characteristics of feet: 12 participants (18 feet), 6 bilateral Baseline severity: mean Pirani score 4.9 (range 3 to 6) SRF casting group Characteristics of feet: 18 participants (26 feet), 8 bilateral Baseline severity: mean Pirani score 5.3 (range 2 to 6) |
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Interventions | Comparison of cast materials: plaster of Paris versus SRF using the Ponseti method Both plaster of Paris and SRF groups received weekly above‐knee plasters according to Ponseti method. Achilles tenotomy was performed if dorsiflexion was < 15 ° and after sufficient abduction of the foot, approximately 60 ° was achieved. Participants in both groups were fitted with FAO at the end of casting. Follow‐up: mean for SRF group, 35.8 ± 11.3 months, mean plaster of Paris group 23.7 ± 14.4 months |
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Outcomes | Pirani score Number of casts required for correction of clubfoot Need for percutaneous tendo‐achilles tenotomy Total time in casts (weeks) Ease of cast removal Duration of cast removal (minutes) Methods of cast removal Complications relating to the casting material Compliance with post‐correction FAO Deformity relapse Need for repeat Ponseti casting Need for ancillary surgical procedures. |
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Conflicts of interest | Quote: "Competing Interests: None declared" | |
Funding | Not stated | |
Notes | Location: Canada Dates conducted: July 2007 to December 2008 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Low risk | Randomisation was performed using concealed number‐tracked envelopes according to a computer‐generated randomisation list |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was 1 dropout in each group |
Selective reporting (reporting bias) | High risk | Insufficient reporting of relapse data |
Other bias | Unclear risk | The trial report did not include sufficient detail to judge whether there could be other bias |