Elgohary 2014.
| Study characteristics | ||
| Methods | RCT. Prospective 2‐arm, parallel‐group design Participants were randomised (not feet) |
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| Participants | 46 children with 74 feet were managed by Ponseti technique. 5 participants (8 feet) were lost to follow‐up and were excluded; 41 participants with 66 feet with CTEV were included Inclusion criteria: idiopathic CTEV with Pirani score < 4 Exclusion criteria: idiopathic CTEV with previous surgical interference to the affected foot PARTICIPANT CHARACTERISTICS Traditional group Age mean (range) in weeks: 10.7 ± 6.28 (1 to 23) Sex (male:female): 14:6 Characteristics of feet: 14 bilateral, 6 unilateral (4 right and 2 left) Baseline severity: mean (SD) Pirani score 5.7 (0.62) Accelerated group Age mean (range) in weeks: 11.57 ± 6.9 (2 to 26) Sex (male:female): 12:9 Characteristics of feet: 11 bilateral, 10 unilateral (5 right and 5 left) Baseline severity: mean (SD) Pirani score 5.13 (0.61) |
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| Interventions | Ponseti standard protocol versus Ponseti accelerated protocol for treatment of initial CTEV The Ponseti standard group underwent treatment with long leg plaster casts (toe to groin) which were changed weekly. An Achilles tenotomy was performed if dorsiflexion was < 10 °. They then wore abduction bracing for 23 hours a day for 3 months followed by night‐time wear only, until 3 years of age The Ponseti accelerated group underwent the same treatment with the exception that long leg plaster casts were changed twice a week Follow‐up: Traditional group (range): 12 ‐ 48 months (25.25 ± 8.67) Accelerated group (range): 12 ‐ 44 months (23.38 ± 9.21) |
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| Outcomes | Pirani score Number of casts before tenotomy Timing of tenotomy Time from onset to complete correction |
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| Conflicts of interest | Quote: "Conflict of Interest. None" | |
| Funding | Not reported | |
| Notes | Location: Mansoura University Hospital, Egypt Dates conducted: June 2010 to August 2013 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants were assigned odd and even numbers in different groups. It was not stated if allocation of numbers was random |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and personnel was not possible |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were not blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 5 participants (8 feet) were lost to follow‐up and were excluded |
| Selective reporting (reporting bias) | Unclear risk | Unclear risk of minor adverse events |
| Other bias | Unclear risk | The trial report did not include sufficient detail to judge whether there could be other bias |