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. 2020 May 15;2020(5):CD008602. doi: 10.1002/14651858.CD008602.pub4

Sanghvi 2009.

Study characteristics
Methods RCT. 2‐arm, parallel‐group design
Randomisation of participants to each group (not feet)
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
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
Outcomes Radiographic
Range of movement
Scoring system according to Atar 1992
Conflicts of interest None stated
Funding None stated
Notes Location: India (assumed)
Dates conducted: not stated
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