Pittner 2008.
| Methods | RCT. Two‐arm parallel‐group design | |
| Participants | 34 participants with 42 CTEV feet who attended authors outpatient clinics Inclusion criteria: initial presentation of CTEV Exclusion criteria: none stated PARTICIPANT CHARACTERISTICS 3 participants excluded prior to data analysis. 1 lost to follow‐up, 1 had medical complications and 1 switched groups during treatment Fibreglass Age mean (SD) weeks: 1.07 (0.57) Sex male (%): 69% Characteristics of feet: 13 participants. 16 feet: 8 left, 8 right Baseline severity: Dimeglio scale score average: 13.1 Plaster Age mean (SD) weeks: 1.89 (1.88) Sex male (%): 100% Characteristics of feet: 18 participants. 23 feet: 9 left, 14 right Baseline severity: Dimeglio scale average: 12.3 |
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| Interventions | Semi‐rigid (fibreglass) casts versus plaster of Paris casts for Ponseti treatment of initial presentation of CTEV Randomisation was done according to medical record number. Feet were enrolled separately, but participants were randomised, i.e. if a participant had bilateral CTEV, both feet were randomised to the same group In the semi‐rigid (fibreglass) group, casting was done using Scotchcast Softcast (3M). In the control group, plaster of Paris was used Follow‐up: end of treatment |
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| Outcomes | Dimeglio scale Parent satisfaction questionnaire |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Sequence generated by medical record number. Not stated how this was done |
| Allocation concealment (selection bias) | High risk | Sequence generated by medical record number |
| Blinding (performance bias and detection bias) All outcomes | High risk | Unable to blind intervention providers. Assessors not blinded. Participant blinding unlikely to affect outcome |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Several participants were excluded after randomisation or lost to follow‐up. Their data were removed from the study |
| Selective reporting (reporting bias) | Unclear risk | Outcomes not stated at outset but reported in results |
| Other bias | Unclear risk | Insufficient information |