Sanghvi 2009.
| Methods | RCT. Two‐arm parallel‐group design | |
| Participants | 42 participants with 64 CTEV feet Inclusion criteria: idiopathic CTEV, initial presentation Exclusion criteria: myelocele, meningomyelocoele, arthrogryposis multiplex congenital, other neuromuscular disorders PARTICIPANT CHARACTERISTICS Basline severity: not stated Ponseti 21 participants Age mean (SD): 13.2 (11.9) weeks Sex male (%): 62% Characteristics of feet: 30 feet. 18 bilateral (9 participants): 6 right, 6 left Baseline severity: not stated Kite 21 participants Age mean (SD): 12.2 (10) weeks Sex male (%): 67% Characteristics of feet: 34 feet. 26 bilateral (13 participants): 5 right, 3 left Baseline severity: not stated |
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| Interventions | Ponseti versus Kite technique for treatment of initial CTEV Randomisation of participants to each group (not feet) In the Ponseti group, casts were changed every 7 to 10 days. Achilles tenotomy was performed in those with residual equinus. Bracing in abduction orthosis using Denis‐Brown splints was done with the affected foot at 70° of external rotation and the unaffected foot at 40° to 45° of external rotation. Splints were worn full time until walking age, and then at night only. During the day, shoes with an open toe box, straight medial border. Lateral flaring of the sole and reverse Thomas heels were used until the age of 4 to 5 years In the Kite group, toe to groin casts were changed every 7 to 10 days until full correction. The final position was maintained in full time bracing in a neutral position with a heel lock and straight medial bar. Once the participant began walking, the brace was used at night only. During the day, shoes with an open toe box, straight medial border, lateral flaring of the sole and reverse Thomas heels were used until the age of 4 to 5 years Follow‐up average: 36 months |
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| Outcomes | Radiographic Range of movement |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding (performance bias and detection bias) All outcomes | High risk | Unable to blind intervention provider. Assessor not blinded. Blinding of participant unlikely to affect outcome |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
| Selective reporting (reporting bias) | High risk | Incomplete outcome reporting, e.g. radiographic. Cannot be entered into the meta‐analysis |
| Other bias | Unclear risk | Insufficient information on baseline assessment for both groups |