Selmani 2012.
| Methods | RCT. Two‐arm parallel‐group design | |
| Participants | 100 participants with 150 CTEV feet Inclusion criteria: idiopathic CTEV, less than 3 months of age, initial presentation (no prior treatment) Exclusion criteria: myelocele, meningomyelocele, arthrogryposis multiplex congenital, other neuromuscular causes PARTICIPANT CHARACTERISTICS Ponseti 50 participants Age mean (SD): 35.3 (25.4) days Sex male (%): 60% Characteristics of feet: 76 feet. Baseline severity: Pirani Score mean (SD): 5.2 (0.8) Kite 50 participants Age mean (SD): 32.45 (26.3) days Sex male (%): 56% Characteristics of feet: 74 feet. Baseline severity: Pirani Score mean (SD): 5.1 (0.7) |
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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 until the foot was corrected or the participant was one year of age. 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 years Follow‐up average (SD): 36.2 (3.2) months In the Kite group, toe to groin casts were changed every 7 to 10 days until full correction or the participant was one year of age. 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 years Follow‐up average (SD): 35.1 (2.5) months |
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| Outcomes | Pirani score, range of movement | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random computer number generation |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding (performance bias and detection bias) All outcomes | High risk | Intervention provider could not be blinded. Assessors were blinded. Participant and carer blinding not possible, which could 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 excluded from final analysis |
| Selective reporting (reporting bias) | Unclear risk | Described functional outcome of corrected feet only. Adverse events not documented |
| Other bias | Unclear risk | Unknown if relapsed patients were part of original failure group. Treatment for relapsed cases in the Kite group not stated |