Rijal 2010.
| Study characteristics | ||
| Methods | RCT. 2‐arm, parallel‐group design Randomisation of feet (not participants) |
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| Participants | 38 participants with 60 CTEV feet who presented to 1 outpatient clinic Inclusion criteria: CTEV Exclusion criteria: prior intervention for CTEV, over 2 years old PARTICIPANT CHARACTERISTICS Age mean (SD, range) days: 195.7 (202.81 3 to 720 days) Sex male:female: 29:9 Basline severity: unclear (report states the groups were equal at baseline for age, sex and Pirani scores) Ponseti Characteristics of feet: 30 feet. 10 unilateral, 8 (4 participants) bilateral. The remaining 12 feet (12 participants) were bilateral cases where 1 foot was randomised to each group Kite Characteristics of feet: 30 feet. 6 feet unilateral, 12 feet (6 participants) bilateral. The remaining 12 feet (12 participants) were bilateral cases where 1 foot was randomised to each group |
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| Interventions | Ponseti versus Kite technique in initial treatment of CTEV Casts were changed in both groups at weekly intervals for 10 weeks. Tendo Achilles tenotomy was undertaken in both groups for those with residual equinus deformity. Feet which were not corrected at the end of 10 weeks were subject to surgical correction Follow‐up: end of treatment |
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| Outcomes | Pirani score | |
| Conflicts of interest | Quote: "Conflict of Interest: None" | |
| Funding | Quote: "Source of Support: No" | |
| Notes | Location: Nepal Dates conducted: July 2005 to May 2006 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomized....using computerized random number generation technique on Microsoft Office Excel 2007" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind intervention providers. Participant blinding unlikely to affect outcome |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Observers blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
| Selective reporting (reporting bias) | High risk | Insufficient information on adverse events. Unsure of operative intervention required after each intervention |
| Other bias | Low risk | |