Sanghvi 2009.
Study characteristics | ||
Methods | RCT. 2‐arm, parallel‐group design Randomisation of participants to each group (not feet) |
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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:female: 13:8 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:female: 14:7 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 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 Browne 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 Scoring system according to Atar 1992 |
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Conflicts of interest | None stated | |
Funding | None stated | |
Notes | Location: India (assumed) Dates conducted: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information on baseline assessment for both groups The details of randomisation were not stated |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to determine whether allocation concealment was undertaken |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind intervention provider. Blinding of participant unlikely to affect outcome |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Assessor not blinded |
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 | The trial report did not include sufficient detail to judge whether there could be other bias |