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. 2014 Aug 12;2014(8):CD008602. doi: 10.1002/14651858.CD008602.pub3

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)
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
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